USFDA completes regulatory inspection of Natco's Vizag formulation facility

At the end of the inspection, the facility received two observations, one on written production process control procedure and the other on investigation procedure

Biocon Biologics receives 5 procedural observations after US FDA inspection at Bengaluru facility

The US FDA completed a pre-license inspection of Biocon Biologics’ biosimilars manufacturing site at Biocon Park between April 20 and April 29, 2026

Wanbury's Patalganga site clears Korea FDA inspection with zero observations

Patalganga plant received zero observation from USFDA earlier

Frontage Laboratories expands China presence with Teddy Lab acquisition

OneSource secures GMP approval from Brazil for its flagship facility in Bengaluru

This approval marks a significant milestone in OneSource’s ongoing commitment to quality and regulatory compliance

Biocon Biologics embarks on a three-stage strategic journey

Successfully transformed the organization from a two-country operation focused on development and manufacturing to a fully integrated company with a strong commercial engine bringing us closer to patients in over 120 countries

CDSCO, NRAI meets WHO international standards for vaccine regulations

India has been declared ‘functional’ against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI

Shilpa Medicare Bio Analytical unit gets "No Action Indicated" classification from USFDA

This Unit of Shilpa Medicare is engaged in testing biological samples of clinical studies

Carbogen Amcis (Shanghai) completed ANVISA Audit

A five-day inspection was concluded successfully with no critical and no major observations raised

Shilpa Medicare Unit IV, Jadcherla has cleared TGA, Australia GMP inspection

This inspection is the fourth major regulatory inspection (after Russia, Canada and Brazil), cleared by this site in the past two years