Torrent Pharma

You might also like

Download as pdf or txt
Download as pdf or txt
You are on page 1of 33

1 HISTORY OF TORRENT PHARMACEUTICALS

These words sum up the efforts of the Torrent group, which integrates people, processes and potential towards the betterment of mankind. It all began with the toil of one enterprising individual, Shri. U N Mehta, when he ventured on his own to create history in the Indian pharmaceutical industry by implementing successfully the concept of niche marketing. His journey, characterized by ups and downs, reached a milestone in 1970, with the launch of Trinicalm Plus, an effective tranquilizer in the niche segment, central nervous system (CNS). The foundations for Torrent were laid when 'Trinity Laboratories' began operations under the able guidance of Shri Mehta whose efforts are worthy of emulation. 'Trinity' was renamed 'Torrent' and with this not only did the company get a new name, it also focused on establishing its own manufacturing facilities in the early 80s. Torrent augmented its efforts with the expansion of its manufacturing capacity, emphasis on marketing and creating business opportunities through focus on exports. Torrent Pharmaceuticals Limited recorded a quantum leap in the year 1994. It has also been rated India's ninth best company among capital intensive companies in terms of ROCE in a study by ETIG-BCG in 2001. In recognition of the consistent performance Torrent Pharmaceuticals Limited has been receiving accolades from various quarters, such as the President's award for highest pharmaceuticals exports of Rs. 1570 million in 1991-92. The Company that had a humble beginning has now grown to become one of the leading players in pharmaceuticals. It has ambitious plans for the years ahead. The emphasis is on Post-2005 opportunities with greater focus on the international market, in particular the lucrative North American market.

MESSAGE FROM CHAIRMAN


To embark on a journey of success one needs the tools of preparedness, foresight and strategy. These lead to the path of growth and high quality operation. It is imperative to combine these three forces in an industry, where every drop of medicine and every capsule acts like a pivot tilting the pan balance of life in favour of fitness and wellbeing. Realizing the responsibility on the shoulders of each member of Torrent Pharmaceuticals Limited, we endeavour to be one of the most competitive companies in the industry with emphasis on efficiency in operations, reliability for customers and thrust on discovery and development of New Chemical Entities. As the human existence is challenged by incomprehensible diseases and ailments, we attempt to reach the core of scientific processes to unearth their remedy. We are an organization that combines scientific, financial, managerial and operational skills and resources to rejuvenate your life. As our research assets, business infrastructure and human capital integrates to flower a robust performance to provide an impetus to the Indian pharmaceutical industry as whole. We are a company, which was cradled by the most arduous and sincere entrepreneur in the country, benefited with the support of the flourishing economy of the state and the presence of a diligent citizenry eager to attain success. Gearing up for the future, we have the key success factors necessary to withstand the winds of change. The encouragement provided to build a highly skilled and creative research and development team, which is reinforced by the state-of-the-art infrastructure. Our well-recognized market presence with a strong product portfolio, which is being marked up with newer brands. Streamlined and efficient manufacturing capabilities, which boosts of technical prowess, high quality production and cost effectiveness. Also a well monitored marketing and distribution network, which is aimed at attaining brand equity among our wide-reaching customer base. The success and eminence of Torrent Pharmaceuticals Limited began as the dream of one man extended to be transformed into the dream of many. We strive to accomplish our dreams and goals to bring greater effulgence in the future."

Mission: We commit ourselves to total customer care by delivering world-class


products and services.

Vision: To be the leader is in the pharmaceutical industry. Values: A set of core values continue to guide us through the process of transforming
the conglomerate into a high-performing and caring organization for our customers, employees, shareholders and society.

Improving quality of life of our customers, as we believe quality is a way of life. Creating value for our shareholders, for the trust bestowed on us.
Building an empowered and ethical Torrent family, as the foundation for a bright future.

Responsibility towards the society and environment, as we owe our existence to them.

Being innovative in solutions, for being different, counts. Striving for excellence in whatever we do, to follow the exclusive path to leadership. Flexibility and speed shall be our oars for navigating the turbulent seas.

CORPORATE PROFILE
The flagship company of Torrent group, Torrent Pharmaceuticals Limited, is a dominant player in the therapeutic areas of cardiovascular (CV) and central nervous system (CNS) and has achieved significant presence in gastro-intestinal, dialectology, anti-infective and pain management segments. To cater to new niche segments and sharpen its focus among customers, Torrent Pharma has six marketing divisions, each catering to defined therapeutic segment. A 2300 strong field force caters to around 2, 00,000 doctors across the country, which makes it rank fifth in terms of market reach. Torrent Pharmas competitive advantage as a manufacturer stems from its worldclass manufacturing facilities. Its manufacturing facilities at Indrad, Gujarat, comply with WHO, cGMP, MHRA and TGA norms and have received ISO 9001, ISO 14001 and OHSAS 18001 (Occupational Health and Safety Management System) and ISO/IEC17025 certifications. With a view to cater to its growth requirements, Torrent Pharma commissioned a new formulations manufacturing facility at Baddi, Himachal Pradesh, in November 2005. The facility has a capacity to manufacture 3600 million tablets, 400 million capsules and 18 million Oral Liquid bottles, per annum and would cater to the domestic formulations requirement. Torrent has a modern and well-equipped state-of-the-art R&D Centre, built with an investment of US $ 40 million. It is manned by more than 525 highly qualified scientists, with a combined experience of over 2500 scientific man-years in Drug Discovery and Development. Torrent Pharma has earmarked 9% of sales year-after-year for R&D advancement. In the International operations arena, Torrent Pharma exports to more than 50 countries around the world with over 1000 product registrations. The international business has been broadly divided into five zones- USA, Latin America, Russia and CIS, Western Europe and CEE and Rest of the World (ROW). For its export excellence in International Business, Torrent Pharma has won several prestigious export awards. Torrent Pharma is now gearing up to enter the advanced highly regulated international markets. Torrent Pharma has incorporated Zao Torrent Pharma in Russia, Torrent Do Brasil Ltda in Brazil, Torrent Pharma GmbH in Germany, Torrent Pharma Inc. in USA and Torrent Pharma Philippines Inc. in Philippines. These wholly owned subsidiaries will become a springboard for entry into several regulated and less regulated international markets.

QUALITY POLICY
Since its establishment Torrent's manufacturing facilities have maintained the highest standards of quality control and assurance adhering to the self enunciated SOPs (Standard operating Procedures) for efficient and hazard-free operations. In a similar way, Torrent Research Center has various departments and personnel monitoring the manufactured products and processes. We adjust and adapt to the changing needs of our customers and remain dedicated in our efforts to serve them to the best of our ability. We at Torrent firmly believe that customer is the king. We work together to bring in health and happiness and enhance the quality of life. "WE THE EMPLOYEES OF TORRENT PHARMACEUTICALS LIMITED ARE COMMITTED TO ACHIEVE EXCELLENCE IN QUALITY STANDARDS AND ALWAYS SUPPLY PRODUCTS AS PER GLOBAL REQUIREMENTS. WE SHALL CREATE AN ENVIRONMENT WHERE EACH EMPLOYEE CONTRIBUTES TO ALL ASPECTS OF OUR BUSINESS PROCESSES. WE SHALL STRIVE FOR CONTINUOUS IMPROVEMENT TO MEET WITH CUSTOMER SATISFACTION."

CODE OF BUISNESS CONDUCT


(A) Introduction (B) Corporate and Organizational Values 1) Integrity 2) Gifts 3) Conflict of Interest 4) Legal Compliance 5) Respect for People 6) Environmental Commitment 7) Safety 8) Confidential and Proprietary information 9) Financial Information Company Assets, Computer Network Use and 10) Security 11) Records Maintenance and Management (C) Compliance with the Code (D) Certification

5 (A) Introduction: 1. This Code is approved by the Board of Directors in their meeting dated 26 July 2005 pursuant to the requirements of Clause 49 sub clause I D of listing agreement (SEBI code on corporate governance). 2. The Code is applicable to: Members of the Board Senior Management Cadre comprising CEO's / Executive Directors (not member of the Board), Vice Presidents and General Managers both together referred to as "Employees" hereafter. 3. The Code with the exception of clause D (Certification) is also applicable to all other employees not covered as above. 4. The Code of Business Conduct (Code) lays down important corporate values that shape the Companys value system and business practices and represents cherished values of the Company. 5. The Code provides guidance to employees in recognizing and dealing with important ethical and legal issues and fosters a culture of honesty and accountability. 6. This Code is not intended to cover every legal or ethical issue that may arise in course of the business. When required, advice or guidance must be taken from the appropriate person in the Senior Management Cadre. (B) Corporate and Organizational Values: 1. Integrity - doing what is right: Personal integrity, upheld on a day-to-day basis, is the unshakable foundation for corporate integrity. Long-term, trusting business relationships are built by being honest, open and fair. Employees are expected to uphold the highest professional standards. 2. Gifts: Employees will not solicit any gifts from their business relationships. Employees shall reject unsolicited gifts that may be perceived as intended to influence any business decision. Any gift which is consistent with customary business practices, inexpensive gifts, corporate gifts, infrequent business meals, celebratory events and entertainment, provided that they are not excessive or create an appearance of impropriety, do not violate this policy. Acceptance of cash gift is prohibited. 3. Conflict of Interest: Employees, whether dealing in personal or official capacity, are expected to avoid activities, agreements, positions, business investments or interests, and other situations that are in conflict or appear conflicting with interests of the Company or that may interfere with their individual performance.

6 Concerns about conflicts of interest may be addressed through either:


Prior approval in writing of or Complete and timely disclosure to appropriate organizational authority.

It is always conflict of interest to work simultaneously for a competitor, material customer or supplier. 4. Legal Compliance: The Companys policy on legal compliance requires every employee to adhere to the legal and regulatory requirements, in all material respects, that affect his or her job. Employees must adhere to this policy on legal compliance and associated reporting. It is essential that information provided to the regulators is accurate and not misleading. 5. Respect for People: Employees are expected to treat co-employees and business associates fairly and, irrespective of hierarchical level, with dignity and respect. Being treated fairly means that employees shall be judged on merits. Senior Management Cadre must maintain an open line of communication and to listen to all employees. 6. Environmental Commitment: The Companys business will be conducted in an environmentally friendly and responsible manner. Employees shall: ensure compliance with the spirit and intent of environmental laws, regulations and standards; Incorporate environmental protection as an integral part of the design, production, operation and maintenance of Company's facilities. 7. Safety: Company assigns highest priority to the safety of its employees. No job is important enough to justify unsafe operations. Supervisors and managers are responsible for monitoring the use of all reasonable safeguards in the workplace including Company procedures, safe work practices, and personal protective equipment. However, ultimately all employees are responsible for their own safety. Every employee must, for his or her own and fellow workers' health and welfare, abide by the Company procedures and safe work practices, and use all appropriate personal protective equipment. 8. Confidential and Proprietary Information: Company information, including self generated computer software applications, may be confidential or proprietary. Employees have to be careful about disclosure of such information to people outside the Company or to employees who need not know or possess the same.

7 When there is a legitimate business need to share confidential or proprietary information with outsiders, it may be disclosed after prior approval of appropriate authority and under an appropriate confidentiality agreement protecting such information. Confidential and proprietary information must not be treated casually or left unprotected. Employees are prohibited from using Companys property or information, or their position within the Company, for personal gain. 9. Financial Information: Financial information on Companys operations and performance provided to shareholders, equity analysts, creditors, newspapers and such others, whether statutory or voluntary, must be accurate and reliable. Disclosure of financial and business information to the public at large or to any interested person shall be governed by the Code of Corporate Disclosure Practices for Prevention of Insider Trading prescribed by SEBI. Communication to the Press or such other media will be organized by the Corporate Communications Department and Employees should not talk about Company matters with a reporter, either on or off the record. In order to protect the investing public, securities laws make it illegal for those with unpublished price sensitive information to buy or sell securities (stocks, bonds, options, etc.). Employees must not indulge in insider trading and abide by the Companys Code of Conduct for Prevention of Insider Trading. 10. Company Assets, Computer Network Use and Security: Employees must make responsible use of Company assets in their personal possession such as telephones, computers and other hardware, software, internet connection, networks and the information that runs on them in a responsible manner. Employees must: Use telephone, computers and peripherals and internet responsibly and primarily for legitimate business purposes and personal uses should be reasonable and kept to a minimum. Protect the security of computer systems. Not engage in communications that might be considered offensive, derogatory, defamatory, harassing, obscene or otherwise vulgar. Not use Company communications systems to improperly disseminate copyrighted or licensed materials, or proprietary information. Not use Company communications systems to transmit chain letters, advertisements or solicitations (unless authorized). Not visit inappropriate Internet sites; and Always protect information used to access computers, networks or systems.

8 Companys electronic communications system and information will be monitored for compliance with Company policy and applicable laws. Employees must note that they are not entitled to privacy privilege in respect of the same. 11. Records Maintenance and Management: Employees must maintain and manage appropriate records and information pertaining to affairs of the Company under their purview, including records and information in electronic form like e-mails, computer files etc. (C) Compliance with the Code: As a condition of employment / association with the Company, Employees are expected to comply with and strictly adhere to the standards of conduct contained in this Code and underlying policies and procedures. When in doubt, this Code casts the responsibility on the Employee to seek clarification and guidance as to the proper course of conduct from relevant authority. Employees who are aware of any misconduct under this Code, illegal activity, fraud or abuse of Company assets must report such matters to the Managing Director. The employees reporting any misconduct shall be suitably protected and no unjust action will be taken against any such employee for making such a report. (D) Certifications: Employees to whom the Code is applicable shall every year affirm to the Board of Directors their compliance with the Code in the format attached herewith as Annex A. The Managing Director will make a declaration in the annual report for each year that the above affirmations have been received from the Employees.

DOMESTIC OPERATION
Torrent, true to its tradition, barring a lull in the late nineties, has rapidly introduced a slew of new products. Alprax, an anxiolytic product, is Torrent's number one brand with turnover exceeding Rs.289 million (US$ 5.8 million) is also a market leader. The other Torrent brands, which figure in the top 200 Indian Brands, are Dilzem (Diltiazem), Domstal (Domperidone), Droxyl (Cefadroxyl) and Listril (Lisinopril). In 2001-02, it launched 31 new products, notable among them being Moxif (Moxifloxacin), Lefra (Leflunomide), Nexpro (Esomeprazole), Adcef (Cefdinir), Feliz (Citalopram), Neasyn SR (Nicotinic acid) and Zaplon (Zaleplon), some of these are first time launches in the Indian market. Torrent has made its remarkable presences in Antibacterial field by introducing Quintor (Ciprofloxacin), Uroflox (Norfloxacin), Droxyl (Cefadroxil), and Moxif (Moxifloxacin). It is a leader in the range of cardiovascular products market including Dilzem (Diltiazem), Listril (Lisinopril), and Nikoran (Nikorandil), Deplatt (Clopidogril). In Gastro intestinal range Torrent has its key products like Topcid (Famotidine), Omizac (Omeprazole), and

9 Ranitin (Ranitidine). Diclogesic (Diclofenac Sodium & Paracetamol) are the leading brands in the NSAID segment. Cardiovascular Therapy Anti-hypertensive Anti-anginal Lipid Lowering Agent Anti-platelet

Anti-diabetic NeuronPsychiatric Therapy Anti-psychotic Anti-epileptic Anti-parkinsonism Anti-depressant Anxiolytic Dementia Hypnotic Mood Stabilizers For Improved Brain Metabolism

Antimicrobial Therapy Gastrointestinal Therapy

Anti-bacterials Anti-fungal Anti-viral Anti-ulcerant Anti-emetic Gastroprokinetic Anti-diarrhoeal Irritable Bowel Syndrome Ulcerative Colitis

Pain Therapy Miscellaneous

Analgesic and Anti-inflammatory Erectile Dysfunction For De-addiction Anti-Hemophilic Anti-BPH Anti-asthmatic Anti-obesity Vitamins For Dysfunctional Uterine Bleeding For Postmenopausal Osteoporosis

10

MANUFACTURING
Overview: Torrents manufacturing facility at Indrad, Gujarat, was set up in 1989. Today, the Indrad facility is at par with international standards. It complies with WHO, cGMP, MHRA and TGA norms and has received ISO 9001, ISO 14001 and OHSAS 18001 (Occupational Health and Safety Management System) certifications; adequately reflecting Torrents commitment towards quality and safety. Attainment of such standards have also opened the key to gaining footholds in regulated, lucrative markets like the US and EU for Torrent Pharma. Torrent firmly believes that quality can not be talked into a product, but has to exist inherently. Its efforts towards realizing world-class quality standards came into limelight with the Quality Excellence Gold Award received from the Indian Drug Manufacturers Association (IDMA) for four consecutive years viz. 2000, 2001, 2002 and 2003. Infrastructure:

Land - 178,000 sq. metres Built-up Area - 50,000 sq. metres for Formulations, 10,000 sq. meters for API Excellent Support Services Finished Products - Oral Dosage Form, Injectables, Freeze Dried Sterile Injections API - Multi Product, Versatile Facility, Upgraded to International Standards Hygiene Zones Process step dependent special zones created for each type of activity

Manufacturing Capacities (per annum) :: Formulations - Tablets, capsules 6,000 and vials million Bulk Drugs/API 15,000 kg Tie-up with neither Novo nor disk: We have signed an agreement with Novo Nordisk India in August 2005 and part of our parenteral facility is dedicated for the formulation and packaging of Insulin, exclusively for Novo Nordisk. The facility will cater to the increased demand for Novo Nordisk Insulin products in India and will incorporate state of art technology in formulation, filling, inspection and packaging of Novo Nordisk insulin formulations. This facility will have the requisite flexibility to expand and the production will be done with the same state of the art technology and quality standards as practiced across the world by Novo Nordisk. We have been manufacturing Insulin for Novo Nordisks India requirement for more than 15 years now. Our parenteral site for insulin production is dedicated for Novo Nordisk

11 products, and complies with their worldwide norms. On numerous occasions, we have won the award for Best Maintained Manufacturing Site of Novo Nordisk worldwide.

FACILITIES
(a) Tablet Facility:

Tablet facility: Modernized / Upgraded to Meet International Standards. Department has following Hygiene Zones: o 'O' Area - Products exposed to environment o 'E' Area - Products in close containers o Entry from 'E' to 'O' area is restricted by separate gowning procedure. Area-wise personnel and material movement through separate air lock. All manufacturing area has 100% fresh air to avoid cross contamination.

Equipments:

Wet Granulation Dry Compaction / Granulation Pellet Coating Film Coating Enteric Coating Sugar Coating Bilayer Tablet

Equipments: MACHINE Mechanical Sifter Committing mill Drum Blender Jacketed Mixer TOTAL QTY 6 4 1 CAPACITY 100 Kg / Hr 150 Kg / Hr 100 Kg

Planetary 2 & 1/1 1 1/1 1/1 2 Bed 1 (Glatt 320 Lit 450 Lit / 900 Lit 100 Kg / Hr 160 Kg. / 300 Kg. 160Kg. / 300 Kg

Rapid Mixer Granulators Roll Compactor Fluid Bed Dryers Cage Blenders Turbo Sifters Fluidized Processor Gmbh)

Lifting & 1/1 Positioning Device

160 Kg. / 300 Kg

12 Tipplers Compression Machines Coaters 2 8 1 4 150 Kg / Hr 6.0 Million Tabs / Shift 300 Kg 160 Kg

(b) Capsule Facility:


ENCAPSULATION Hard Gelatin o Pellet Filling o Tablet Filling o Combination of Powder/Pellet & Powder / Tablet Filling Soft Gelatin

(c) Parental Facility: Facility has been designed under technical guidance of M/s. Novo Nordisk, Denmark which Complies International Regulations?

VIAL : INSULIN AMPOULE FREEZE DRYING AREA GREEN : BLUE RED CLASS 10,000 & CLASS 100 UNDER LAF : CLASS 1,00,000 CONTROLLED : ENVIRONMENT

Equipments: MACHINE TOTAL CAPACITY QTY Sealing 1 7200 Vials / Hr. 6600 Ampoules / Hr 1200 Vials / Cycle 10000 Vials / Shift

Vial Filling & Compact Line Ampoule Filling & Sealing 3 Compact Line Vacuum Freeze Dryer 1 Semi-Automatic Vial 1 Filling & Sealing Line

13 (d) Quality Control Facility: Major Instruments:


TOC Analyzer Gas Liquid Chromatograph with Head Space with Auto Sampler attachment to estimate very trace level (ppm) of organic volatile /toxic solvents to meet ICH guidelines Total Organic Carbon analyzer with SSM for Cleaning Validation of manufacturing equipment to ensure that product is practically free (ppb level) from previous product. Ultra Pure Water Purification system for HPLC grade water (TOC< 10 ppb and particles < 0.22 micron, Endotoxin < 0.001 cfu/ml.) Video Microscope for monitoring the crystallinity of Insulin products. Fourier Transform Infra Red Spectrophotometer to ensure total identity/ genuineness of the product. Slit to Agar to monitor Viable Count / Area monitoring to ensure that the Production, QC and Stores areas are meeting international standards. Seri Test, a closed concept membrane filtration system for sterility testing to reduce the rate of false positive results. Automatic Glass Ware Washing and Drying Machine to ensure right quality of cleanliness of the glass wares. High Performance Liquid Chromatographs - 6 Nos. High Performance Liquid Chromatographs with Low Temperature cooling and Auto sampler attachments for very precise and accurate analysis of Insulin products

Other Instruments: UV / Visible And IR Spectrophotometers Metrohm Auto Titrator High Performance Thin Layer Chromatograph Atomic Absorption Spectrophotometer Electronic Micro And Semi Microbalances Met One Particle Counter For Non Viable Count Coulter Counter For Suspended Particle Analysis Dissolution Test Apparatus Disintegration And Friability Testers Digital Conductivity, TDS And Ph Meters Digital Polarimeter Auto Clave, LAF, DHS, Depyrogenator 3 2 1 1 6 1 1 6 3 6 1 6

14 (e) Packaging Facility:


Aluminium - PVC / PVDC (Blister) Aluminium - Aluminium Foil (Strips) Aluminium - Aluminium (Cold forming) Bulk Packaging Pouch Packaging (triple laminated foil) Vials / Bottle Packging

Area Design:

Primary Packaging ('O' Area) - 100% Exhaust Each machine in closed cubicle Connected to Dust Extraction System Controlled environment (low RH - selective) Secondary Packaging ('E' Area) Segregation of each packaging line Stringent checks and controls at final packaging. MACHINE Blister Machine Packing TOTAL QTY 5 CAPACITY / SHIFT 5.0 Million Per Shift 2.5 Million Per Shift 6000 Carton Per Shift 30000 Pouch / Shift 0.6 Million / Shift QTY MODEL (4) (2) (1) (2) (1) M/C (2) (3) (1)

Strip Pack Machine 3 Carton Printing 4 Machine Pouch Pack 2 Machines Alu-Alu Blister 1 Machine

DESCRIPTION OF MAKE M/C & MODEL FPM 240 CH P.G.L. (BLISTER) FMP 230 T P.G.L FMP 230 T P.G.L STRIP PACK M/C HEMSON STRIP PACK M/C GANSONS SAMS STRIP PACK M/C TOOLS AUTO CARTON NIMECH CODING M/C AUTO LABELLING NIMECH M/C

15 BLISTER / STRIP PLH TAB ENTERPRISES RECOVERY M/C P.G.L TR0PICAL DEHIMIDIFIER MPRTEC LEAK TEST UNIT TOSHNIWAL OUTER LABEL OF LIBRA M/C WT.BALANCE (30 LIBRA KG) WT.BALANCE (100 LIBRA KG) ON LINE SHRINK SHRINK PACK. PACK LTD ON LINE CODING KLAAS M/C MARKETING CONVEYOR BELT BAKLANCE (1 TO 2 LIBRA KG) STRAPPING M/C NOVEL STRAPPING M/C NOVEL (Manually) FPM 230 A P.G.L ALM AMBA LAB.M/C ALM A.H.IND AMBICA VLM LAB.M/C AMBICA LAB PALLET TRUCK M/C (f) Active Pharmaceutical Ingredients Plant Facility: As a backward integration to the Formulation Division, a separate API Plant located in same premises having their own utility and raw material store facilities. API production plant is divided in two part, Technical plant and Pharma area. Technical plant is provided with once through filtered air while Pharma area is provided with once through filtered air-conditioned air. Technical Plant is equipped with SS and Glass Lined reactors having capacity 160 Lit. to 5000 Lit., SS and MS Rubber Lined Centrifuges, Tray dryer, Filters etc. There are separate Store Rooms (2 Nos.) for storage of Intermediates, out of which one is airconditioned. In our Pharma area, we have equipments for handling finished product like Tray Dryer, Air Jet Mill, Sifter, Blender, Multi Mill and packing area. Pharma Area is also has separate storage facilities to store materials at different stages.

(3)

(1) (1) (1) (1) (2) (10) (3) 8 (9) (1) (1) (1) (3) (3) (2) -3

16 Department has 5 Nos. 100 Lit. Glass Assemblies to carry out production of API in small batch size. A separate Process Development Lab is available for backup of our production department. API has separate utility facilities for utility like Steam, Brine, Air, Chilled water, Hot water, Hot Oil and Vacuum and also separate D.G. set to backup with GEB power failure. There is a separate Raw Material Store for storage of raw materials of API. It has separate Tank Farm area for storing solvents like Methanol, Acetone, IPA, Toluene and also for acids like HCl, Sulphuric and Spent acid and have also separate store for hazardous chemicals. Under the expansion program, the Pharma Area would be equipped with 3 separate modules where 3 separate products could be processed at the same time maintaining all GMP and FDA norms. Upply Chain Management Facility: Supply Chain Management activities at the manufacturing plant mainly include: Production Planning / Inventory Control / Warehousing / Information Technology. It coordinates with the Procurement Division for timely availability of inputs and with Marketing Department to make all products available timely, as per the requirements, and distribution of products to C & F Agents all over the country, and of finished goods to Cargo Handling Agents for exports.

Production Planning and Control:


It is one of the core functions of all the manufacturing activities. Activities include

Production Planning Indent of raw material and packaging material. Inventory monitoring to meet with marketing requirements

Raw Material Stores: RM Stores has 100% controlled environment storage for active and inactive raw materials. Dispensing of raw material as per prevailing cGMP norms and SOPs. Facilities

Separate Areas like Receipt, Under Test and Approved raw materials. 3 Separate Sampling Booths with Reverse Laminar Air Flow System. 4 Dispensing Booths with Reverse Laminar Air Flow System.

17 Packing Material Store:


Separate area for Receipt/ Under test and Approved Materials All packaging materials are stored as per cGMP guidelines and procedures laid down in SOPs. Maintaining controlled environment for primary packaging materials. Dispensing batch-wise as per SOPs.

Bonded Store Room (BSR):


Formulations and API are kept in BSR in controlled environmental conditions. Facilities are also available for cold chain products The finished products are dispatched from BSR to Duty Paid Store for Domestic sales after compliance of Central Excise Duty formalities. Dispatches of finished goods to Cargo Handling Agents for Exports

Duty Paid Store (DP Store):


Storage facility available for controlled condition and cold chain products. Country wide 22 C & F Agents catered by DP stores. Promotional inputs dispatches to concerned Marketing Field Force.

Active Pharmaceutical Ingredients Store (API Store):


Activities similar to raw materials stores of formulation plant are undertaken Caters to the requirements of API manufacturing facilities. Handles bulk storage of various chemicals, solvents and hazardous materials Facility available to store the RMs in controlled environment Utmost care, safety precautions to maintain better working conditions.

Information Technology (I.T.):


Helps to maintain manufacturing and distribution activities. EIS and MIS reports generated for analysis and decision making

Engineering Services Facility: The department works as a support function for the entire plant activity, including new project, formulation and API production, administration, estate upkeep, environmental controls and ensures compliance of all statutory as well as regulatory directives. This calls for multi disciplinarily technical expertise and constant knowledge update to keep pace with changing trends in the industry. Facilities: A) Generation Double RO system B) Circulation loops Distribution C) Sanitation At 90c

18

HVAC Vacuum cleaning UPS Electrical Other:


Product specific design For equipment cleaning and house keeping For computers and all critical process equipment In-house power generation capacities

Energy monitoring instruments Testing and calibration instruments Application software for process controller Mechanical workshop Auto CAD System with Plotter

Major Equipment Capacity: Power Transformers Diesel Generators Steam Boilers Chilled Water Plants Chilled Brine Plants HVAC Systems Air Compressors Purified Water R.O. System (USP 25 Quality) Purified Water D. M. System Utility Water R.O. System Effluent Treatment Plant 5700 KVA 3750 KVA 20 TON 1750 TR 360 TR 60 Nos. 2000 CFM 12 m3 / hr.

45 m3 / Reg. 38 m3 / hr. 600 m3 / day

Services Offered by Engineering Services Department: Project Engineering:


Study of current trends Evaluation of existing equipment / facilities Conceptual design Layout and equipment design Preparation of Technical Specifications and Tender Vendor evaluation & development Installation of the designed system and facilities System automation

19 Maintenance Engineering Equipment, Building and Premises:

Preventive maintenance o Breakdown maintenance and failure analysis o Machinery modification o System validation Instrument calibration o Energy audit

Safety and Environmental Protection Facilities:

Effluent Treatment Plant o Gas scrubber o Dust collectors o Fire hydrants and extinguishers Personnel protective accessories

Systems:

On site / Off site emergency plan Work permits Environmental air quality monitoring Treated effluent water quality monitoring Environmental audit Fire drills

Torrents manufacturing facilities at Indrad meet cGMP guidelines and comply with WHO, cGMP, MHRA and TGA norms. Regulatory Approvals: The Finished Dose Formulation facility at Indrad, Gujarat (India) caters to the growing demand for exports of branded generic products. The facility has been approved by following regulatory authorities:

cGMP (EU) BFDA (Taiwan) MHRA (UK) BfArM (Germany) TGA (Australia) Anvisa (Brazil) MCC (South Africa) Ministry of Health (Latvia) MCAZ (Zimbabwe) NDA (Uganda) Anvima (Columbia) National Institute of Pharmacy (Hungary)

20 Quality Certifications:

ISO 9001-2000: Quality Management System ISO 14001: Environment Management System OHSAS 18001: Occupational Health & Safety Management System ISO/IEC- 17025 by NABL Quality Excellence Gold Award, IDMA (Indian Drug Manufacturers Association)

The Active Pharmaceutical Ingredient (API) manufacturing plant at Indrad (Gujarat, India) has been approved by European authorities.

QUALITY CONTROL DEPARTMENT


We have a modern and well-equipped Quality Control (QC) laboratory, which ensures that our products are pure, safe and effective and are released only after thorough analysis as per stringent specifications, methods and procedures developed according to international guidelines viz. EU cGMP, MHRA, WHO, TGA, etc. Ours QC Lab is a one of its kind laboratory and amongst the first few pharma companies to get the NABL accreditation. It is also the first in India Pharmaceutical industry to successfully pass the re-accreditation by NABL. Our QC department has all necessary instruments for analysis of API, finished products, packaging and related materials used. Low Chart - RM / PM Inspection:

21 Flow Chart - Finished Products Inspections:

Flow Chart - In process Checks ::

QUALITY ASSURANCE DEPARTMENT


Torrent's quality policy is mandated and supported by the Executive Management and coordinated by an independent Corporate Quality Assurance (CQA) Department. Highlights:

First Indian pharmaceutical plant to get ISO 9001, ISO 14001 & OHSAS 18001certification. Quality Assurance is independence of Manufacturing. In-Process quality is checked during manufacturing. Validation of facilities, equipments, process, products & cleaning as per Master Plan. Complaint Handling. Storage of quality record and control samples. Stability Studies. Registration Documents (DMF)

22 Quality Assurance Department handles the following activities: Technology Transfer:


Receipt of product design documents from Torrent Research Centre (TRC). Distribution of documents received from TRC. Checking & approval of documents generated based on TRC documents i.e. Batch Manufacturing Record. Scale-up and validation of product

Validation:

Preparation of validation plans for facility / equipments / process including cleaning. Approval of protocols for validation of facility / equipment / product / process. Team member for execution of validation of facility / equipment / product / process.

Documentation Control:

Controlled distribution and archiving of documents. Control of changes made by proper change control procedure. Approval of all documents

Assuring Quality of Products:


cGMP training SOP compliance Audit of facility for compliance Line clearance In-process counter checks Critical sampling Record verification Release of batch for marketing Investigation of market complaints Stability of products

Quality Improvement Plans:


Feedback received from the compliance team Proposals for corrective & preventive actions Annual products review Trend Analysis of various quality parameters for products, environment & water.

23

PRODUCTS
Highlights:

Leaders in Cardiovascular and Central Nervous System areas. Significant presence in Gastrointestinal, Anti-Infective, Anti-diabetics and pain management segments.

Products manufactured include:


TABLETS CAPSULE PARENTERAL

List of APIs Manufactured:


Nicorandil Risperidone Venlafaxine Hydrochloride Ropinarole Hydrochloride Duloxetine Hydrochloride Ormeloxifen Hydrochloride Nebivolol Hydrochloride Lamotrigine Sertraline Hydrochloride Clopidogrel bisulphate

Recent Level 1 area product


Atomoxatine Hydrochloride Rivastigmine Hydrogen tartrate Esomeprazole Sodium Awards :: Quality Award Quality Award Quality Award Quality Award Excellence Torrent Ltd. Excellence Torrent Ltd. Pharmaceuticals 1990 Pharmaceuticals 1993

Excellence Torrent Gujarat Biotech 1997 Ltd. Baroda Excellence Torrent Ltd. Pharmaceuticals 1999 Pharmaceuticals 2000 Pharmaceuticals 2001 Pharmaceuticals 2001

Quality Excellence Torrent Award Gold Trophy Ltd. Quality Award Excellence Torrent Ltd. Torrent Ltd.

ISO 9001:2000

24 ISO 14001:1996 OHSAS 18001:1999 Torrent Ltd. Torrent Ltd. Pharmaceuticals 2002 Pharmaceuticals 2002

Entrepreneurship :: The Indian Drug Torrent Laboratories Pvt. 1979-89 manufacturing Ltd. th Association (10 Annual Celebrations) Aanant Award Rotary Club Ahmedabad (North) Shri U.N. Mehta of Shri U.N. Mehta 1991 1994-95

Global Trust Bank (On Shri U. N. Mehta Torrent 1996-97 Occasions of Ahmedabad Group Branch) Gujarat Business of the Shri U.N. Mehta Torrent 1997 year Award Group Ahmedabad Management Shri U.N. Metha Torrent 1997 Association Award Group Udyog Rattan Shri U.N. Mehta Torrent 1997 Group

Others :: Gold APICON ASICON 1996 Medical Field :: Annual Conference of Torrent Laboratories 1980 Indian Psychiatric Pvt. Ltd. Society AIIMS, New Delhi Torrent 1991 1993 Annual Conference of Torrent Neurological Society of Pharmaceuticals Ltd. India Mental Health Torrent Education & Research Trust and Family Planning Association All India Congress of Torrent obstetrics & Gynecology Scientific Exhibition Torrent Ltd. 1995 Torrent Pharmaceuticals Ltd. 1996

1995

1997

25

INTELLECTUAL CAPITAL
An organizations blueprint for success is designed by its employees. At Torrent, we take pride in what we do and more so in those who make it happen for us. Engaging the best minds in the business, nurturing them with care in a professional environment and bringing out the best in them is our continuous endeavor. We strive to build teams of professionals specialized in various fields to function effectively as a team and we encourage them through a conducive work culture.

Baddi Plant:
Set up with an investment of over Rs. 130 crores, the Baddi Plant is a most modern, stateof-the-art facility that will cater to the requirements of domestic markets. The Plant commenced operations in November 2005 and has a capacity to manufacture 3600 million tablets, 400 million capsules and 18 million Oral Liquid bottles, per annum. Other operations at the Plant have been streamlined, with the critical machines and operations already functional at the Plant. Production of most of the domestic products has already been shifted to Baddi.

Infrastructure:

Land 82, 237 sq. metres Built-up Area 23, 000 sq. metres Finished Products: Capsules, Liquids, construction): Tablets,

- Oral Dosage Forms (Main Plant): Tablets, - Oral Dosage Forms (Cephalosporins Plant under Capsules, Dry Powder Suspension, Insta use liquids.

Hygiene Zones - 'O' Open Product Area, 'E' Closed Product Area, 'F' Non Production Area

The Plant has been approved by ISO/IEC 17025 in May 2006. The Chemical and Biological testing Labs have been accredited by NABL and the QC Lab attested by NABL to be in accordance with the international standards.

RESEARCH AND DEVELOPMENT


Torrent R & D Centre has a team of over 560 scientists, who continue to offer dedicated services in the areas of Discovery Research, Generic Drug Development and New Drug Delivery Systems/Value added generics. Thereby transforming discoveries into the highest quality therapeutic products.

26 Set up at an investment of over US $ 40 million, the R&D Centre conforms to international quality standards and houses the most advanced and up to date equipments. It has one of the most advanced infrastructures for both basic and applied research. Currently, Torrent has seven discovery projects in pipeline 3 in Diabetes & related complications, 1 in cerebro-vascular, 2 in obesity and 1 in cardio-vascular. Torrent has filed 219 patents for NCEs in all major markets worldwide; the patent offices of USA, Japan, Europe, Czech Republic, Australia, Hong Kong, Russia and India have granted / accepted 123 patents so far. Opportunities for undertaking contract and collaborative research are being actively pursued. There would be a distinct focus on out-licensing of its NCEs for development and global marketing. The Establishment:

Total land area: 125,000 sq mts Built-up area: 38,000 Sq mts o Laboratories: 24,000 Sq mts o Support services: 14,000 Sq mts Investment: US $ 40 million

Unique Architectural Feature: It was specially designed with passive downdraft evaporative cooling which saves the airconditioning plant capacity by about 150 T.R. Goals: To develop safe and effective therapeutic options for undiscovered and unmet medical needs.

To be the most productive Research and Development Centre. Quality remains an essential attribute in all aspects and activities at the R&D Centre.

Objectives:

To develop capabilities to design and synthesize new chemical entities based on advances in patho-physiology and therapeutic modalities in selected treatment areas and provisions for out licensing them at the appropriate stage of development. To evaluate their therapeutic and safety profile and guide the lead entities through the process of development to a stage of clinical application. To provide "incremental innovation" for existing products i.e. to look for new indications, to develop innovative, therapeutically beneficial formulations to extend the product life and the market segment. To develop methods of analysis, lay down specifications and work out quality assurance norms in relation to all the above activities and in doing so, to facilitate the process of scaling up from laboratory scale to plant and towards regular production.

27

To assess developments and advances worldwide with a view to licensing in or buying in technologies at an early date and to assimilate and improve upon them for commercial production. To build and maintain a good scientific reputation and provide intellectual stimulation for the Torrent staff through continuous interaction with academia and contribution to science and to inculcate a "Scientific Temper" amongst its technical members. To be conversant with advances in all spheres of healthcare and to evaluate the desirability of venturing into new areas.

National / International Alliances: The Torrent R&D Centre is focused on developing safe and effective therapeutic options for undiscovered and unmet medical needs. Complementing Torrents advanced R&D infrastructure and facilities, are its alliances with several leading institutions/pharma majors. Astra Zeneca, Sweden, U.K Birla Institute of Technology, Pilani M. S. University, Baroda University of Pune, Pune

DISCOVERY AND DEVELOPMENT


Development: Within a span of 5 years, the major achievements to the credit of the Torrent Research Centre are the development of world class fermentation technology for Pen-G, synthesis of Omeprazole, Sparfloxacin, Nicorandil, Lamotrigine, Sertraline, Sildenafil Citrate, Repaglinide, Rosiglitazone, Clopidogrel, Sibutramine and Cerivastatin and the introduction of low dose combination of Lisinopril and Hydrochlorothiazide(Listril Plus/Forte), matching international quality standards. This rational combination was specifically formulated keeping in mind the needs of Indian patients. First Time Introduction by the Centre:

Fluconazole 0.3% Eye drops for the first time in the world. Esomeprazole (20,40mg) Multi Unit Particulate System (Pellets compressed in the form of tablet) for the first time in India. Rosiglitazoe 2mg/4mg Immediate Release + Metformin 500mg Sustanded Release Dual Retard Technology launched in the form of Inlay Tablet for the first time of India. Few Non-Conventional Dosage Forms Developed.

Dilzem CD (Diltiazem)

Controlled Release Pallets Sustained Release + Alprax Plus (Alprazolam Immediate Release Bi SR + Sertraline) Component Capsule Lamitor DT Dispersible Tablet

28 (Lamotrigine) Calcigard (Nifedipine) Valparin Alkalets (Sodium Valproate) Valparin Chrono (Sodium Valproate) Fegem (Iron Polymaltose Complex) Droxil Ready (Cefadroxil) Dilzem Inj (Diltiazem) Nikoran IV (Nicorandil) Nexpro (Esomeprazole) Enselin (Rosiglitazone Metformin SR) Discovery Portfolio: Under the discovery program, the centre has found some very promising molecules and patent applications for these molecules have been filed in India, under the PCT and the US.

Soft Gelatin Capsule Enteric Coated Tablet Sustained Release Matrix Tablet Chewable Tablet Ready To Use Suspension Life Saving Injectable Lyophilized Injectable Pellets compressed Tablet

in

MF Dual Retard Technology in IR+ form of Inlay Tablet

SOCIAL RESPONSIBILITY
The mantle of service, earlier the prerogative of few, has been extended to a larger part of society, the business community. There has been a call for corporate entities to put in resources and services for the betterment of society. Service to the community through the establishment of facilities, infrastructure and uplift plans for those in need is also an agenda with the corporate of the 21st century. In the course of doing business, corporations are also taking keen interest in implementing their social responsibility. Whether at international, national, regional or local levels their activities and operations are carried out keeping their social responsibility objectives in mind. Realizing its commitment to society Torrent has been contributing to the goodwill of the community. Torrent has at all times provided dependable products for its customers, as a good reputation is a brand in itself. In its pursuit to imbibe these values, Torrent aims at becoming a reliable and dependable partner in nation-building, rising to any occasion at times of crisis. Torrent donated Rs. 1 crore to the Prime Ministers National Relief Fund to rebuild the lives of Tsunami victims. Torrent was among the first to rush in aid immediately after the 2001 earthquake in Gujarat. Torrent Power AEC and Torrent Power SEC restored power supply in the region

29 in double quick time. Torrent also helped in the construction of a fully equipped 60-bed hospital in Kutch, the only one of its kind to be fully geared for psychological rehabilitation in the region. Realizing the need for specialized hospitals, Torrent has established and manages medical institutions such as the U. N. Mehta Institute of Cardiology and Research Centre. It contributed substantially to the Chief Ministers Relief Fund during the drought of 2000 in Gujarat. Reconstructed Primal Garden, Ahmedabad, from a neglected garden to a haven for nature lovers and fitness enthusiasts. Torrents Public Health Awareness Campaign, the first of its kind in the country, received the Public Service Campaign award. Torrent's other significant contributions include establishment and financial support to dispensaries, health foundations, community centers and hostels for meritorious students.

MILESTONE
2006 The API and formulations manufacturing facilities located at Indrad (Gujarat, India) got US FDA approval 2006 Entered into an in-licensing deal with Tasly of China to market its Cardiotonic pill in India 2006 Torrent Pharma Japan Co., Ltd. incorporated in Japan 2005 Torrent Australasia Pty Ltd. incorporated in Australia 2005 New manufacturing unit at Baddi, Himachal Pradesh, set up to cater to domestic formulations market. Torrent Pharma signed an agreement with Novo Nordisk India to establish a new, dedicated formulation and packaging facility for Insulin, exclusively for Novo Nordisk. Acquired Heumann Pharma GmbH & Co Generica KG, a Pfizer group company, in Germany. Two new marketing divisions- AXON and NEURON set up to cater to neuropsychiatry segment.

30

Entered into research collaboration with AstraZeneca for developing novel antihypertensive drug. 2004 Torrent Pharma Philippines Inc. set up. Torrent Pharmas manufacturing facility at Indrad received MHRA (UK) and TGA (Australia) approvals Restructuring of marketing divisions addition of new division, Delta. and

2003 Brazilian Sanitary Surveillance Agency accredited Torrents R&D Centre with ANVISA, authorizing it to conduct Bioequivalence Studies. IDMA Quality Excellence Award Gold Trophy for its formulations and API facilities. Torrent Pharma Inc. set up in USA. GMP Certification received from European Union by Torrent Pharmaceuticals Manufacturing Plant MCC South Africa approval received by Torrent Pharmaceuticals manufacturing plant. 2002 Acquisition of a small Brazilian company, renamed "Torrent do Brasil Ltda." Discovered and patented AGE (Advanced Glycosylation End-products) molecule. Torrent Pharmas manufacturing certified with ISO 14001:1996. facilities

Torrent Pharmas manufacturing facilities accredited with OHSAS 18001:1999. Torrents R&D Centre received ISO/IEC 17025:1999 for its facilities by National Accreditation Board for Testing and Calibration Laboratories (NABL). Addition of a new marketing division, MIND 2001 Torrent Pharmas manufacturing facilities

31 received ISO 9001:2000 Certificate. IDMA Quality Excellence Award Gold Trophy for its formulation facility. Torrent Pharma ranked in the top 10 Indian Companies in terms of Return on Capital Employed (ET - BCG Study Feb - 2001). 1999 Restructuring of Torrent Pharmaceuticals Ltd. through formation of three new divisions Prima, Vista, Psycan. 1998 Torrent Exports renamed as Torrent Ltd. as part of restructuring and consolidation exercise. 1997 India Infusions Ltd. merged with Torrent Pharmaceuticals Limited. 1996 State-of-the-art R&D Centre commissioned. Torrent Pharmaceuticals Limited acquires pharma related investments and business of Torrent Exports Limited. 1995 Torrent Gujarat commissioned. Biotech Limited plant Torrent.

1989 Second manufacturing plant of Pharmaceuticals Limited at Chhatral. 1983 First Export Order

1980 First major manufacturing facility of Torrent Pharmaceuticals Limited at Vatva. 1971 Trinity Laboratories renamed Pharmaceuticals Limited. as Torrent

1959 Mr. U.N.Mehta started pharma operations.

AWARDS
2002-03 Torrent Pharma bagged the Gold Trophy for IDMA Quality Excellence Award 2003 for both Formulations and API manufacturing facilities 2001-02 Torrent Pharmaceuticals bagged the 'Best Suppliers' award by the Sri Lankan State Pharmaceutical Corporation.

32 Torrent Pharma bagged the Gold Trophy for IDMA Quality Excellence Award for its Formulations facility and Silver Trophy for its API manufacturing facility

2000-01 Torrent Pharma bagged the Gold Trophy for IDMA Quality Excellence Award for its Formulations facility 1999-00 GCCI Export Appreciation Award. Torrent Pharma bagged the Gold Trophy for IDMA Quality Excellence Award for its Formulations facility. 1996-97 Corporate Business Man of the year Award to Shri U.N.Mehta. 1992-93 Torrent Pharmaceuticals Limited received IDMA Quality Excellence Award. 1991-92 Torrent Exports Limited received Export Award from Govt. of Gujarat. Torrent Exports Limited received National Export Award. 1990-91 Torrent Exports Limited received Export Award from Govt. of Gujarat. Pride of Asia International award for excellence in Pharmaceuticals Products by international Friendship. 1989-90 Torrent Exports Limited received Chemexcil Trishul Award for highest Pharma Exports. Torrent Pharmaceuticals Limited received IDMA Quality Excellence Award. 1988-89 Torrent Laboratories Limited received Chemexcil Export Award. 1987-88 Torrent Laboratories Limited received Chemexcil Export Award. Torrent Exports Limited received Export Award from Govt. of Gujarat. 1986-87 Torrent Laboratories Limited received Chemexcil Export Award. Torrent Laboratories Limited received IDMA Quality Excellence Award. Torrent Exports Limited received Export Award from Govt. of Gujarat.

33 1985-86 Torrent Laboratories Limited received Chemexcil Export Award. Torrent Laboratories Limited received IDMA Quality Excellence Award. Torrent Exports Limited received Export Award From Govt. of Gujarat. Torrent Laboratories Limited received IMC Golden Jubilee Endowment Award for Export Performance. 1984-85 Torrent Laboratories Limited received Chemexcil Export Award. Torrent Laboratories Limited received Udyog Ratna Award. CERTIFICATIONS 2005-06 Torrent Pharmas QC department at Chhatral manufacturing plant accredited with ISO/IEC-17025 by NABL Torrent Pharmas Chhatral plant certified by TGA, Australia. 2004-05 Torrent Pharmas Chhatral plant certified by MHRA of UK. 2003-04 Brazilian Sanitary Surveillance Agency accredited Torrents R & D Centre with ANVISA, authorizing it for conducting Bioequivalence Studies. 2002-03 Torrent Pharmaceuticals Ltd. Manufacturing Facilities received ISO 14001:1996 Certificate. Pharmaceuticals Ltd. Torrent Manufacturing Facilities received OHSAS 18001:1999 Certificate. Torrent Research Centre received ISO/IEC 17025:1999 for its facilities by National Accreditation Board for Testing and Calibration Laboratories (NABL). 2001-02 Torrent Pharmaceuticals Ltd. Manufacturing Facilities received ISO 9001:2000 Certificate. 2000-01 Torrent Research Centre received OECD Standards of Good Lab. Practices Certificate from Dutch Health Ministry.

You might also like