Research & Development

Our Company has a dedicated R&D center with Three units located in IMT Manesar, Gurugram, Haryana & One in Mumbai for inhalation products Thane, Maharashtra. One unit of this R&D center is recognized by the DSIR, and one unit is in compliance with WHO GMP and has been inspected by the USFDA. We also have two additional R&D centers which are operated through our non-wholly owned Subsidiaries, including the COPMED Research Centre in Dehradun, Uttarakhand and the Mediforce Research Centre at Paonta Sahib, Himachal Pradesh.

As of March 2024, we have made 60 filings for abbreviated new drug applications (ANDAs) with the USFDA (including Paragraph IV filings), Out of which 41 have been approved & additionally 3 tentatively approved. In rest of the world (ROW) countries, we have filed 729 drug product applications, out of which we have received 504 approvals and remaining 225 applications are under review at various jurisdictions.

As of March 2024, Mankind Pharma has submitted 26 API drug master files (DMFs) in USA, and 7 in other markets including Australia, Canada and UK. Also, 11 API Certificate of Suitability (CEPs) have been filed in Europe and all are approved. Further, Mankind Pharma has also submitted 40 DMFs in ROW markets for more than 10 APIs in support of registration of more than 40 drug product applications.