Industrial Pharmaceutics

CA:502T
Tenzin Palden
12018353

ABOUT:

Dr. Reddy's Laboratories is an Indian multinational pharmaceutical

company located in Hyderabad, Telangana, India. The company was
founded by Kallam Anji Reddy, who previously worked in the mentor
institute Indian Drugs and Pharmaceuticals Limited. Dr. Reddy's
manufactures and markets a wide range of pharmaceuticals in India and
overseas. The company has over 190 medications, 60 active pharmaceutical
ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and
biotechnology products.
Dr. Reddy's began as a supplier to Indian drug manufacturers, but it soon
started exporting to other less-regulated markets that had the advantage
of not having to spend time and money on a manufacturing plant that
would gain approval from a drug licensing body such as the U.S. Food and
Drug Administration (FDA). By the early 1990s, the expanded scale and
profitability from these unregulated markets enabled the company to
begin focusing on getting approval from drug regulators for their
formulations and bulk drug manufacturing plants - in more-developed
economies. This allowed their movement into regulated markets such as
the US and Europe. In 2014, Dr. Reddy Laboratories was listed among 1200
of India's most trusted brands according to the Brand Trust Report 2014, a
study conducted by Trust Research Advisory, a brand analytics company.
By 2007, Dr. Reddy's had seven FDA plants producing active
pharmaceutical ingredients in India and seven FDA-inspected and ISO 9001
(quality) and ISO 14001 (environmental management) certified plants
making patient-ready medications – five of them in India and two in the UK.
In 2010, the family-controlled Dr Reddy's denied that it was in talks to sell its
generics business in India to US pharmaceutical giant Pfizer,which had
been suing the company for alleged patent infringement after Dr Reddy's
announced that it intended to produce a generic version of atorvastatin,
marketed by Pfizer as Lipitor, an anti-cholesterol medication. Reddy's was
already linked to UK pharmaceuticals multinational Glaxo Smithkline.

CEO:

Israeli graduated from Midrasha Art School of Beit Berl College.

He received a post-graduate degree from the Bezalel Academy of Art and
Design in 2005. In his works, Israeli emphasizes the idea of preserving Israel
identity - collective as well as personal. He thinks about war, terror,
religious freedom - the main tensions existing in Israeli society and creates
a visual concept around them.
PROFESSIONAL PROFILE:

Erez Israeli became Group Executive Vice President & Chief Business
Process Officer in November 2012. As of February 2014, he also serves as
Interim Head of Global Quality.

From 2009 to 2012, Mr. Israeli served as President of Teva’s API Division.

Previously, from 2006 until 2008, Mr. Israeli was VP Asia Operations, with
responsibility forestablishing TAPI’s operational infrastructure in India and
China. From 2002 until 2006, he was Vice President Sales & Marketing of
Teva API in North America.

Mr. Israeli joined Teva in 1994. From 1994 until 2006 he held various
leadership positions, including Director of, Generic Business & Sales to
Health Funds at Teva Israel and Director of Finance, Monitoring and
Control at Teva Israel.

LOCATION,PRODUCTION UNIT & RnD:

Reddy's Laboratories is an Indian multinational pharmaceutical

company located in Hyderabad, Telangana, India.
MARKETED PREPARATION:

Venusia cream (aloe vera, squalene, vitamin E) is a moisturizer.

Glimy 1/2/3/4 (Glimepiride 1/2/3/4 mg) tablets belong to a group of drugs

called sulfonylureas (SUs).
Telsartan 20/40/80 (Telmisartan 20/40/80 mg)
tablets belong to a group of drugs called angiotensin receptor blocker.

COMPETITOR OF DR.REDDY’S:
Dishman Carbogen Amcis Ltd. Divi's Laboratories Ltd.
Elantas Beck India Ltd. Eris Lifesciences Ltd.

FAILURE:
US FDA warns Dr Reddy's Laboratories of ban
if flaws are not fixed

HYDERABAD: The US Food and Drug Administration has threatened to ban all
products made at certain facilities of Dr Reddy’s Laboratories, India’s second
largest drugmaker, unless they conform to prescribed global manufacturing
standards. The US regulator may also withhold approval of new applications
from Dr Reddy’s if it fails to complete all corrections, it said in a letter dated
November 5 that was posted on its website on Wednesday.

While making several critical observations pertaining to failures of Dr Reddy’s

to contain recurrent violations, the FDA made it clear that it was not satisfied
with nine responses submitted by the Indian drugmaker between December
2014 and September 2015.

The FDA said its inspection teams had "identified significant deviations from
current good manufacturing practice (CGMP) for the manufacture of active
pharmaceutical ingredients" at Dr Reddy’s plants located at Srikakulam in
Andhra.

SUCCES:

In the year 2000 Cheminor Drugs Ltd a group company merged with the
company and thus the company became India's third largest pharma
company. In the year 2001 the company launched Fluoxetine capsules. They
became the first Indian company to win 180-day exclusivity for a generic drug
in the US.

July 30 — Remembering the Founder of the

Cancer Institute (WIA), Dr. Muthulakshmi
Reddy
 July 30, 2022, marks the 136th birth anniversary of the Founder of the Cancer
Institute (WIA), Dr. Muthulakshmi Reddy. As a faculty member of the Institute, I
reflect on the stories of this resilient and indomitable changemaker in the field of
oncology in India. Through her learnings as the first woman legislator of the
erstwhile Madras Presidency and as the Founder of the Avvai Home, Dr. Reddy
built up a wealth of interdisciplinary knowledge that played an important role in
the establishment of the Cancer Institute along with the Women’s Indian
Association (WIA). Dr. Reddy was the first secretary of the WIA and later
became its Life President.

Dr. Muthulakshmi Reddy made several appeals to set up a

specialized cancer centre in the city of Madras.

Dr. Reddy made several appeals to set up a specialized cancer centre in the city of Madras.
Among the several appeals, the most noteworthy was an appeal made to the members of
the King George V Memorial Fund Committee in 1935 driven by her on behalf of several
Women’s Associations in the city of Madras, including the WIA, the Madras Presidency
Muslim Ladies’ Association, Sri Sarada Ladies’ Union, the Young Women’s Christian
Association, and the Madras branch of the All-India Women’s Conference. Dr. Reddy
always regarded the value of collaboration across disciplines to help achieve her goals and
dreams. Through these appeals, Dr. Reddy expressed the importance of setting up a
specialized cancer centre equipped with modern infrastructure to establish training and
research activities for the prevention and treatment of cancer. Along with the WIA, Dr.
Reddy was able to setup the Women’s Indian Association Cancer Relief Fund; her
untiring efforts in making appeals continued to be presented to relevant Ministries in
power until the hospital was first setup in 1954.

Reference: wikipedia:[https://en.wikipedia.org/wiki/Dr._Reddy%27s_Laboratories ]

ABOUT:
Novartis AG is a Swiss-American multinational pharmaceutical corporation
based in Basel, Switzerland and Cambridge, Massachusetts, United States
(global research).[1] It is one of the largest pharmaceutical companies in the
world.
Novartis manufactures the drugs clozapine (Clozaril), diclofenac (Voltaren;
sold to GlaxoSmithKline in 2015 deal), carbamazepine (Tegretol), valsartan
(Diovan), imatinib mesylate (Gleevec/Glivec), cyclosporine
(Neoral/Sandimmune), letrozole (Femara), methylphenidate (Ritalin;
production ceased 2020), terbinafine (Lamisil), deferasirox (Exjade), and
others.
In March 1996, the companies Ciba-Geigy and Sandoz merged to form
Novartis; the pharmaceutical and agrochemical divisions of both
companies formed Novartis as an independent entity. Other Ciba-Geigy
and Sandoz businesses were sold, or, like Ciba Specialty Chemicals, spun
off as independent companies. The Sandoz brand disappeared for three
years, but was revived in 2003 when Novartis consolidated its generic
drugs businesses into a single subsidiary and named it Sandoz. Novartis
divested its agrochemical and genetically modified crops business in 2000
with the spinout of Syngenta in partnership with AstraZeneca, which also
divested its agrochemical business.

CEO:
 Vasant Narasimhan
Narasimhan received his bachelor's degree in biological sciences from
University of Chicago, his M.D. from Harvard Medical School and his
master's degree in public policy from the John F. Kennedy School of
Government.
Narasimhan has previously served as Global Head of Biopharmaceuticals
& Oncology Injectables at Sandoz International.
Narasimhan joined Novartis in 2005. From 2014 to 2016, he served as the
Global Head of Development for Novartis Pharmaceuticals. From 2016 to
2018, he held the role of Global Head of Drug Development and Chief
Medical Officer within the company.On September 5, 2017, he was named
the successor of Joseph Jimenez as CEO of Novartis.
He is a member of the U.S. National Academy of Medicine and a member of
the board of fellows of Harvard Medical School. He also serves on the
boards of African Parks, a nonprofit conservation organization, and of the
Pharmaceutical Research and Manufacturers of America.

LOCATION:
Cambridge, MA, USA (Headquarters)

Our offices in Cambridge are located in the midst of multiple renowned academic research
institutions and innovative biotech companies. The headquarters is home to research in the
areas of oncology, ophthalmology, and cardiovascular and metabolic-related diseases.

Basel, Switzerland

Co-located with our corporate world headquarters, our research facility in Basel is an integral
part of the BioValley, Europe's biotechnology hub. Drug discovery here focuses on
autoimmunity, transplantation, and inflammation, as well as musculoskeletal diseases,
neuroscience and oncology

East Hanover, NJ, USA

Located on the same campus as our US Pharmaceuticals Division headquarters, our East
Hanover location focuses on research in cardiovascular and metabolic diseases. It is also home
to information analysis, preclinical safety, and metabolism and pharmacokinetics groups.

Emeryville, CA, USA

Located in the San Francisco Bay area, the Emeryville campus focuses on early discovery and
research activities as a hub for infectious disease research, with additional expertise in structural
and biophysical chemistry, computer-aided drug design and protein engineering across disease
areas.
Shanghai, China

Novartis has an integrated biomedical Research & Development center in Shanghai’s

Zhangjiang Hi-Tech Park in the midst of an emerging cluster of innovative academic, biotech
and pharmaceutical research institutions. Research focuses on infectious causes of cancer
primarily found in Asia and includes efforts in discovery chemistry and biomarker research.

Novartis Institute for Tropical Diseases

As a small-molecule drug discovery research institute, NITD combines the drug-discovery

expertise and cutting-edge technologies of Novartis to fight infectious tropical diseases.

Friedrich Miescher Institute for Biomedical

Research

Founded in 1970, the Friedrich Miescher Institute is devoted to fundamental biomedical research
and focuses on epigenetics, growth control and neurobiology.

The Genomics Institute of the Novartis

Research Foundation
Located in San Diego’s BioMedical research center, GNF is well-known for developing novel
technology to drive cutting-edge drug discovery research, identify new biological pathways and
discover mechanisms underlying human disease.

PREPARATION:

Clozaril