Research & Development

Research and development (R&D) is the foundation for discovering innovative medicines and vaccines that change patients’ lives. Pfizer’s R&D program is designed to develop safe and effective breakthroughs for patients across the globe.

Generally, the R&D process includes basic and translational research, in addition to medicines and vaccine development:

Basic research: Investigates the biological underpinnings of disease and potential therapeutic targets. Performed by academic research centres, government agencies, and industry, often in close collaboration with one another.
Translational research: Connects new knowledge about a process or compound to a practical medical application or therapy. Typically performed by biopharmaceutical companies.
Medicine and vaccine development: Investigates the safety and efficacy of new medicines and vaccines through clinical trials. Typically performed by biopharmaceutical companies.

Our Strengths
1. Excellent infrastructure :-
The Centre is well equipped to handle various developmental challenges in the areas of oral and parenteral medications. Specifically, the available infrastructure includes:

• Dedicated area and labs to handle potent substances like hormones.
• Process Development and Scale-up Labs attached to the manufacturing unit.
• An NDDS laboratory with specialized capabilities like nano-technology, hot melt extrusion, etc.
• A unit to develop parenteral dosage forms ranging from vials to ampoules to pre-filled syringes to large volume parenterals.
• A unit to develop opthalmic and nasal products using the BFS technology.
• Supporting dedicated packaging development labs with multifeeder BQS machinery capable of various packs including multi-product-in-a-blister.
• Dedicated analytical laboratories with UPLC’s, ion chromatography, an amino acid analyser, particle size and particle surface area analyser, hot stage microscopy, USP Type III and Type IV apparatus etc.
• A bio-equivalence laboratory approved by various regulatory bodies like USFDA, MHRA and WHO etc.

2. Excellent talent pool:-

• A team of over 500 scientists dedicated to development of generic formulations, many of which are first-to-file.
• More than 180 patent applications have been filed by a dedicated IP team.
• The scientific team is supported by two separate project management teams dedicated to oral solids and parenteral portfolios. A group of more than 150 supports all regulatory filings across various geographies.

Our Achievements and Capabilities:-
The Centre is capable of developing, scaling up and commercializing various dosage forms spread across tablets, capsules, soft gels, oral liquids, injectables (solutions, suspensions, lyophilized, etc.), and ophthalmic (three piece and BFS) and nasal delivery systems.The focus is to develop products for the US and EU followed by other international markets, including specialized markets like Japan.We can develop complex in-vitro analytical as well as bio- analytical methods for various molecules including extremely potent drug combinations to support the formulation development team.The R&D Centre has developed products and filed more than 200 ANDA’s, around 124 EU Dossiers for products and hundreds of Dossiers in other countries including Brazil, South Africa, Australia and China.The product range covers various pharmacological categories with special focus on anti-retroviral, anti-biotic, CNS and CVS drugs.