R&D
The R&D team was established in 2002 and covers all areas of product development from formulation sciences, analytical services, regulatory expertise and support services. The facilities are spread over an area of ~ 57.000 Sq ft. The team has an enviable track record of successful development of generic medicines, high-barrier products and complex generics.
Formulation development - a team of 50 highly qualified Formulation Scientists with expertise in the development of a wide range of dosage forms
- Tablets, Capsules, ER/SR/CR/MR/DR formulations, EVT Tablets, Pellets, Controlled release pellets
- Parenterals (Lyophilized & Liquid), Solutions, Suspensions, Emulsions
- Topicals (Ointments/creams/eye drops)
- New Drug delivery systems (Oral and parenteral)
- Excellent capabilities in Development of Cytotoxic & Potent drugs
- Handling Special Delivery Systems & Complex Manufacturing processes
- Scale up in Class 100.000 pilot manufacturing area
- Analytical Development - a team of 180 experienced analyst with expertise in:
- API characterization
Analytical Method Development & Validation
- Dissolution Profiling
- Impurity Profiling
- Stability Study (ICH & Custom Condition)
The scientists are supported by 60 regulatory personnel with expertise in dossier compilation and additional regulatory procedures compliant to EMA, FDA, ANVISA and other regulatory agencies.
The R&D group have developed numerous novel technologies, formulations and processes covered by 27 international patents.