Briefs: Dr. Reddy's Laboratories and Ami Organics

Dr. Reddy's Laboratories gets Form 483 from USFDA with 4 observations for API facility

USFDA completes inspection of Lupin's Dabhasa facility with no observations

The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations

Briefs: SMS Pharmaceuticals and Vimta Labs

EDQM conducts GMP inspection of SMS Pharmaceuticals’ API facility

Supriya Lifesciences received GMP certification from ANVISA Brazil

The clearance of this audit marks the successful registration of 8 APIs with CADIFA

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