Search result for 'gmp inspection'

Dr Reddy's Laboratories received two observations from the USFDA following an inspection of its API facility in New York. The observations were related to Good Manufacturing Practices (GMP).

Glenmark Pharmaceuticals reported a consolidated profit after tax of Rs 348 crore in Q3 FY25, driven by strong regional performance. The company also announced a USFDA inspection at its Indore...

Dr Reddy's Laboratories received seven observations from the USFDA following an inspection of its Bollaram facility. The company will address the observations within the stipulated timeline.

Aurobindo Pharma's Hyderabad-based biosimilars facility receives GMP certification from the European Medicines Agency, paving the way for approvals for three biosimilars.

Torrent Pharmaceuticals received a Form 483 with one observation from the USFDA after an inspection of its Pithampur manufacturing facility. The observation is procedural in nature and the company...

Biocon's Q1 profit jumps six-fold to Rs 660 crore, driven by a one-time gain from the Biocon Biologics and Eris Lifesciences collaboration. Revenue also grew slightly.

Biocon Biologics receives approval from the EMA to manufacture biosimilar Bevacizumab at its Bengaluru facility, expanding capacity for European markets. The company also received GMP certificates...

Biocon received four observations from the USFDA after an inspection of its API facility in Visakhapatnam, Andhra Pradesh. The company will address the observations within the stipulated time.

Torrent Pharmaceuticals received a Form 483 with five observations from the USFDA after an inspection of its Gujarat manufacturing plant. The company will respond to the observations within the...