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...
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.
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