Glossary of terms

A R&D Analytical Research &Development

Abbreviated New Drug Application (ANDA) Filed for the launch of a generic version of an existing approved drug
Active Pharmaceutical ingredient (API) It is the substance of a pharmaceutical drug that is biologically active
A biologic is a medicinal product such as a vaccine, blood or blood component, allergenic, somatic cell, gene
Biologics therapy, tissue, recombinant therapeutic protein, or living cell that is used as a therapeutic to treat diseases

Biosimilars Subsequent versions of innovator biopharmaceutical products made by a different sponsor; Generic versions
of Biologics
Chemical Tech Operations (CTO) API manufacturing facility
COBE Code of Business conduct and Ethics
CPS Custom Pharmaceutical Services
DCGI Drug Controller General of India
DMPK Drug Metabolism and Pharmacokinetics
DoE Design Of Experiments
DQA Developmental Quality Assurance
Dr. Reddy's Foundation (DRF) Non-profit partner of Dr. Reddy’s
A document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the
Drug Master File (DMF) appropriate regulatory authority in the intended drug market
European Agency for the Evaluation of Medical Controls regulations across Europe. EMEA coordinates the drug approval process across different national
Product (EMEA) regulatory agencies in Europe
Excipient A pharmacologically inactive substance used as a carrier for the active ingredients of a medication
EVP Employee value proposition
Formulation Tech Operations (FTO) Generic drug manufacturing facilities of Dr. Reddy’s
GDC Global distribution centre
Generic drug A replica of Innovator drug. It has the same active ingredient, strength, and dosage forms
GG Global generics
GMP Good Manufacturing Practices
IPDO Integrated Product Development Organization
IPM Intellectual Property Management
May be defined as biological products, for example, proteins, peptides, antibodies, viruses and vaccines,
New Biological Entity (NBE) used to prevent or treat disease.
The compound with potential to treat a disease. It is a drug that contains no active moiety that has been
New Chemical Entity (NCE) approved by the FDA.
Comprises of:
• Written reports of each individual study,
New drug application (NDA) • Manufacturing data,
• Summary of all available information on safety and efficacy of the drug
• At least two pivotal trials, with one of them conducted in the U.S.
NME New Molecular Entity
PACE Program to Achieve Cost and Capabilities Excellence
PDT Product Development Team
Proprietary Products Focus areas are New Chemical Entities, Differentiated Formulations and dermatology
PSAI Pharmaceutical Services and Active Ingredient
QbD Quality by Design
RA Regulatory Affairs
A small number of people with complementary skills who are committed to a common purpose, performance
Self Managed Teams (SMTs)
goals, and approach for which they hold themselves mutually accountable.
TDC Technical development centre
Regulatory authority in the US. It reviews and approves / rejects any NDA / sNDA / ANDA submitted by
US Food and Drug Administration (USFDA) pharmaceutical companies.