Our Company has a dedicated R&D center with three units located in IMT Manesar, Gurugram, Haryana. All three units of this R&D center are recognized by the DSIR, one unit has implemented WHO cGMP and one unit 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 15th September 2022, we had made 47 filings for abbreviated new drug applications (“ANDAs”) with the USFDA (including eight Paragraph IV filings), out of which 17 have been approved, two have received tentative approval and 28 are still undergoing assessment. As of the date of this Draft Red Herring Prospectus, we had filed for 587 drug product approvals, out of which we had received 401 drug product approvals and had 186 applications pending under review in various jurisdictions including India. As of the date of this Draft Red Herring Prospectus, two out of 24 API drug master files (“DMFs”) which were submitted in the United States had received the ‘Adequate’ letter from the USFDA. Further, as of the date of this Draft Red Herring Prospectus, we had received five approvals out of 11 API certificates of suitability (“CEPs”) submitted in Europe.