Introduction_Formulation development

Our formulation team can develop and deliver a full range of dosage forms used for treatment of various indications as per global quality standards -

Biologics production facility

• Generic Drug Development: Drug products both categorized as toxic and non – toxic where manufacturing involves isolation of personnel eliminating exposure incl., integrated manufacturing lines and isolator technology
• R&D team has vast experience in selection of product for development with respect to market, sales, volume, and therapeutic requirement as part of the strategy for generic drug product portfolio development. This includes selection of molecules with biowaiver (where no clinical or bioequivalence studies are required), by establishing Q1, Q2 and Q3 level similarity thereby minimizing cost of development
• Differentiated Product Portfolio – The team is experienced in the development of differentiated products. Incl., line extensions and product life – cycle management ensuring patient safety as well as product sales. Our experience spans development of liposomes, lipid emulsions, nano – suspensions, extended-release products, targeted delivery systems such as oral and parenteral route of administration
• Re – purposing of drug molecule for different indication – Development of an existing molecule for a new indication or treatment option, for example, where a drug product is reported to have hair growth as a side-effect but is approved for treatment of benign hyperplasia, can be developed for treatment of androgenic alopecia
• Considering the active metabolites of the drug as molecules of interest and developing the product which will lead to better efficacy at reduced dose and targeted action
• Pre – clinical & clinical program – Our approach is to minimize exposure of test products to human subjects with maximum evidence generation as part of study outcome. This assists in reducing cost of clinical trials and faster time to market
• State of the art facility & experienced team in developing analytical tools for drug product characterization along with evaluation of leachable & extractables of the packing components used for drug product storage, incl., nitrosamine impurity evaluation and control
• Team has experience drafting communications and discussing with regulatory agencies as part of the scope of development and getting issues addressed well in advance, to ensure we move development on the right path from initiation.