Tag Archives: USFDA Inspection

USFDA inspection at Alkem’s St. Louis (US) facility concluded with observations, regulators indicate official action

ST. LOUIS (US) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Exchanges, Mumbai headquartered Indian Pharam company Alkem Laboratories Ltd said of the USFDA (US Food & Drugs Administration) concluded inspection at St. Louis (US) facility of the company and that the company will close out all observations

#DLGGujaratConnect | VIAGRA Manufacturer – “Pfizer” shuts Aurangabad & Chennai units in India, impacting 1,700 jobs

MUMBAI | AURANGABAD | CHENNAI | NEW DELHI | AHMEDABAD | RAJKOT –  Following a thorough evaluation of the Aurangabad (Maharashtra) and Irungattukottai (Tamilnadu) plant, Pfizer Ltd has finally decided to shutdown the two facilities in India, on grounds of long-term loss of product demand, making manufacturing at this sites “unviable”, the three page handout

USFDA successfully inspects Alembic’s JV facility Aleor Derma

VADODARA (BARODA) | MUMBAI | RAJKOT – In a press release submitted to the Exchanges in India on Monday, in wee hours before the trading session kicked-off on the Indian Bourses, Alembic Pharmaceuticals Ltd said of Aleor Dermaceuticals Ltd’s facility, getting successfully inspected by USFDA. Aleor Dermaceuticals Ltd. (Aleor), a 60:40 Joint Venture between Alembic

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

US FDA inspection at Moraiya facility of Cadila Healthcare done, no observations issued

AHMEDABAD | MUMBAI | RAJKOT – US Food Drug Administration conducted inspection at Moraiya facility of Cadila Healthcare Ltd between February 6 – 15, 2017, the global food and drug regulatory agency has not issued any observations vide the 10 days inspection conducted at facility, the company update said. Investors and markets cheered the news