Shivalik Rasayan Limited has issued LOA to Medicamen Biotech to use its DMF grade Bortezomib API for formulation of Bortezomib injection 3.5mg/ vial
The inspection closed with zero observations
Dr. Reddy's Laboratories has been issued a Form 483 with four observations
The company will be submitting the responses to US FDA observations within stipulated timeline
The inspection concluded with no observations
Cipla has received 8 inspectional observations in Form 483
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
The plant at Raleigh, North Carolina, USA owned by Aurolife Pharma has received an establishment inspection report (EIR)
The unit has filed 2 Derma products and 1 MDI product.
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