Briefs: Aurobindo Pharma and Granules Pharmaceuticals

Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection

USFDA inspection at Biocon Biologics' manufacturing facility in Johor, Malaysia

Zydus receives EIR for injectables manufacturing facility at Zydus Biotech Park, Ahmedabad

The inspection was a cGMP Inspection and had ended with NIL observations

Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations

The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.

USFDA concludes inspection at Solara's Cuddalore facility with Zero 483 inspectional observations

Briefs: Shivalik Rasayan and Dr. Reddy's Laboratories

Shivalik Rasayan Limited has issued LOA to Medicamen Biotech to use its DMF grade Bortezomib API for formulation of Bortezomib injection 3.5mg/ vial

USFDA completes inspection at Dr Reddy's Laboratories' Bollaram API unit

The inspection closed with zero observations

Briefs: Dr. Reddy's Laboratories and Max Healthcare Institute

Dr. Reddy's Laboratories has been issued a Form 483 with four observations

Briefs: Dr. Reddy's Laboratories

USFDA has issued Form 483 with one observation

Shilpa Medicare gets 2 minor observations from USFDA for Unit VII, Analytical Services Division

The company will be submitting the responses to US FDA observations within stipulated timeline