Shivalik Rasayan issues LOA to Medicamen Biotech to use its DMF grade Bortezomib API

Shivalik Rasayan Limited has issued LOA (Letter of Authorisation) to Medicamen Biotech Limited, to use its DMF grade Bortezomib API for formulation of Bortezomib injection 3.5mg/ vial. Medicamen Biotech Limited has filed its first ANDA with USFDA today.

Dr. Reddy's Laboratories’ API facility at Srikakulam completes USFDA inspection successfully

The United States Food & Drug Administration (USFDA) today completed a Pre-Approval Inspection (PAI) and a routine GMP inspection at Dr. Reddy's Laboratories Limited's API manufacturing facility in Srikakulam, Andhra Pradesh, India (CTO-6). The inspection was conducted from 10th July, 2023 to 19th July, 2023. The inspection closed with zero observations and a classification of No Action Indicated (NAI).