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

Zydus Lifesciences gets 4 USFDA observations for Jarod Injectable facility

Zydus will work closely with the USFDA to address and resolve the observations in an expeditious manner

FDA completes inspection at Biocon Biologics' facility in Bengaluru

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

Aarti Pharmalabs inaugurates phase 1 of greenfield manufacturing facility

Phase 1 has a total reactor capacity of 440 kL with 63 reactors

Apitoria Pharma receives 5 observations from USFDA for API facility

At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported

Eris Lifesciences receives ANVISA approval for sterile injectable facility

Roche’s US subsidiary Genentech breaks ground on $700 million manufacturing facility in North Carolina

The $700 million project is part of Roche’s $50 billion investment in US manufacturing, infrastructure and R&D

Cohance to invest Rs. 23 crore on cGMP Oligonucleotide facility at Hyderabad

This strategic investment strengthens Cohance's integrated oligonucleotide platform

Sandoz to acquire Just–Evotec Biologics facility for $300 million

The companies will now begin detailed contract negotiations and proceed with necessary consultations and approval processes

Concord Biotech successfully completes Russian GMP inspection at its API facility

The inspection was conducted from July 22-25, 2025