R&D

back

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.

Capabilities

Formulation development - a team of 50 highly qualified Formulation Scientists with expertise in development of 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 developed numerous novel technologies, formulations and processes covered by 27 international patents.