Tag Archives: Form 483

USFDA slams Form 483 to Torrent Pharma’s Dahej facility, official action initiated

DAHEJ | AHMEDABAD | MUMBAI | RAJKOT – In a regulatory filing submitted to the Indian Bourses late on Wednesday night, Ahmedabad headquartered pharma major Torrent Pharmaceuticals Ltd said of the company having classified as Official Action Initiated by US food & drugs regulator. The Dahej facility of the company was inspected in March 2019

US FDA issues form 483 to Alembic Pharma’s Panelav facility for oral solids

VADODARA (BARODA) | MUMBAI | RAJKOT – In a regulatory update filed to the Indian Bourses on Friday, Alembic Pharmaceuticals Ltd said of having got their Panelav facility manufacturing general oral solids inspected by US FDA (Food & Drugs Administration) and the regulator having slammed Form 483 to the facility, after inspection. The United States

European Agencies inspect, clear and certify – Biocon’s Bangaluru facility

BENGALURU | MUMBAI | RAJKOT – Kiran Majumdar Shaw promoted Biocon Ltd’s Bengaluru based durg manufacturing facility has been inspected and certified by European Union agencies for adopting and adhering to the the European Union Good Manufacturing Practice and standards, the company said in the filing submitted to the Exchanges in India. Attributing the version

Biocon shares dip on news of US, Euro regulators inspection at Bangalore facility

BANGALORE | MUMBAI | RAJKOT – Biocon Ltd’s Bangalore based sterlite drug product manufacturing facility has been inspected by US and European regulators, the company statement said. US Food & Drug Admnistration (USFDA) has completed pre-approval inspection of Biocon’s Bangalore based sterlite drug product manufacturing facility in this week. The US regulator issued Form 483