News | May 07, 2026
CARBOGEN AMCIS Shanghai site clears unannounced NMPA GMP inspection
Successful inspection outcome strengthens company’s regulatory compliance and manufacturing standards in China
Successful inspection outcome strengthens company’s regulatory compliance and manufacturing standards in China
The US FDA completed a pre-license inspection of Biocon Biologics’ biosimilars manufacturing site at Biocon Park between April 20 and April 29, 2026
The US regulator conducted an inspection at the Amaliya manufacturing plant between April 20 and May 1, 2026
The Puducherry facility, dedicated to Ibuprofen and its derivatives, is equipped with advanced infrastructure to serve both domestic and international markets
Patalganga plant received zero observation from USFDA earlier
The company stated that it will work closely with the regulator to address the observations within the stipulated timeframe
Zero-observation outcomes strengthen global credibility and accelerate CDMO ambitions
The inspection concluded with zero observations, confirming the facility's compliance with current Good Manufacturing Practices
The inspection concluded with one minor observation in Form 483
Granules Consumer Health serves as Granules’ front-end division for OTC products in the US
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