Our Company has a dedicated R&D center with four units located in IMT Manesar, Gurugram, Haryana and 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 December 31, 2022, we have made 54 filings for abbreviated new drug applications (“ANDAs”) with the USFDA (including ten Paragraph IV filings), out of which 29 have been approved, three have received tentative approval and 22 are still undergoing assessment. We have filed for 645 drug product, out of which we had received 451 drug product approvals and we have 194 applications pending under review in various jurisdictions. Four out of 25 API drug master files (“DMFs”) which were submitted in the United States had received the ‘Adequate’ letter from the USFDA. We have also submitted one DMF in Canada, which is currently under review. Further, we have received seven approvals out of 11 API certificates of suitability (“CEPs”) submitted in Europe.