Medicamen Biotech Ltd (MBL) has filed its first Abbreviated New Drug Application (ANDA) in eCTD format for ‘BORTEZOMIB FOR injection 3.5 MG/VIAL” with the US Food and Drug Administration (USFDA). This accomplishment marks a significant milestone for the company, and is expected to prompt a USFDA audit in the future.
MBL’s Research and Development team has internally developed the BORTEZOMIB Active Pharmaceutical Ingredient (API). Shivalik Rasayan Ltd, MBL’s holding company, is responsible for manufacturing the API and has filed the Drug Master File (DMF) of the BORTEZOMIB API with the USFDA. They have also authorised Medicamen Biotech Ltd to use the API for manufacturing BORTEZOMIB injection (3.5 MG/VIAL).
Medicamen Biotech’s shares went up by 5.12 per cent to Rs 755.30 at 01:32 p.m. on BSE.