Medicamen Biotech files ANDA for Bortezomib for injection with USFDA

Written by Ruchika Sharma Published On 2023-07-19T16:18:35+05:30 | Updated On 19 July 2023 4:18 PM IST

Medicamen Biotech files ANDA for Bortezomib for injection with USFDA

New Delhi: Medicamen Biotech Limited has announced that the company has successfully filed the first ANDA in eCTD format for BORTEZOMIB for injection 3.5 MG/VIAL with US Food and Drug Administration (USFDA).

"This is major milestone for the Company which will trigger USFDA Audit in due course of time," Medicamen stated in a BSE filing.

The BORTEZOMIB API has been developed in house by its R&D and the API is being manufactured by Shivalik Rasayan Ltd (Holding company of MBL) who has already filed DMF of BORTEZOMIB API with USFDA and have authorised Medicamen Biotech Limited to use the API for manufacture of BORTEZOMIB injection 3.5 MG/VIAL.

Medicamen BiotechbortezomibUSFDAShivalik Rasayan

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751