Research & Development
Generic Drug product development services for regulatory and semi regulatory markets (USA, EU, canada, MENA regions, Turkey, Brazil etc.)
Analytical method development and validation services with stability studies as per ICH guidelines.
Identifying product opportunities, Developing innovative pharmaceutical solutions and suitable tie-ups with partners in the respective markets.
Developing Para IV / NCE-1 & 505 (b) (2) opportunities leading to possible tie-ups with Innovator/Generic companies.
Conventional and modified release (sustained release, delayed release and targeted release etc) dosage forms development. Intermediates for further processing like functional coated drug granules/pellets, blend, core tablets etc.,
Scale-up, Technology transfer, Exhibit batches Manufacturing, Clinical studies, Complex IP and Regulatory services.
The R&D laboratory is well equipped with various ultramodern equipment and technologies required for conducting high quality research activities.
Patent non-infringing, stable, bioequivalent and feasible formulations for a wide range of sensitive, low soluble and “highly bio variable” molecules.
Patent evaluation, Pre formulation, formulation development, Pharmaceutical equivalence, pilot BE, ICH stability studies, scale-up, technology transfer and submission batches.
Conventional wet and dry granulation technology, extrusion-Spheronization, fluid bed process – wurster – drug loading, drug layering, Pelletization, bilayered tablets, hard gelatin capsules and tablet in capsule.