USFDA conducts product specific pre-approval inspection at Lupin’s Aurangabad facility

Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe

FDA completes inspection at Biocon Biologics' facility in Bengaluru

The U.S. FDA issued a Form 483 with five observations

SMS Pharmaceuticals receives EIR from USFDA for Central Laboratory Analytical Services

The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations

Hikal reports Q1 FY26 consolidated loss of Rs. 22.4 Cr

Hikal has reported total income of Rs. 381.4 crores during the period ended June 30, 2025

Briefs: Emcure Pharmaceuticals and Gland Pharma

Emcure Pharmaceuticals successfully completes USFDA PAI of Oncology facility

Shilpa Medicare Unit VI facility at Dabaspet receives GMP certification from SFDA

This was a full GMP inspection of the entire facility with specific focus on Ondansetron Oral Film drug product

Shilpa Pharma Lifesciences Unit-1 inspected by ANVISA

The audit has been concluded with no major observations

SMS Pharmaceuticals completes USFDA inspection at Central Laboratory Analytical Services

The inspection concluded with zero Form 483 observations

USFDA concludes inspection of NATCO’s Pharma Division, Kothur

The company received seven observations in the Form-483

USFDA concludes inspection at Zydus' oncology injectable plant at Ahmedabad