BackCipla gets 4 observations from US FDA for its three plants in Goa
The US FDA has been issuing Form 483 observations and warning letters to Indian drug makers for failing to meet good manufacturing practice standards laid down by it
Premium
Hyderabad: Drug maker Cipla Ltd on Friday informed stock exchanges that said it got four observations from US Food and Drug Administration (US FDA) for three of its manufacturing facilities in Goa.
“US FDA recently concluded audit of our three manufacturing facilities at Goa and has issued four observations across these three facilities," the company said.
The company didn’t specify the nature of the observations.
Cipla said the observations were primarily “procedural in nature" and the company has already responded to these observations.
“We continue to operate our facilities with a high-level of compliance and control," Cipla said.
Cipla shares which were down by as much as 7% recovered and were trading at Rs583.50 at 2.90% decline at 12.51pm, the benchmark Sensex dropped 0.24% to 27,748.55 points.
US FDA inspected Cipla’s Goa facility last week. Cipla has over 35 state-of-the-art manufacturing facilities for API and formulations in India.
The US drug regulator conveys its concerns on manufacturing practices through Form 483. Companies that receive its observations must respond in writing with a corrective action plan and implement it quickly. If the company fails to meet the regulator’s expectations, a warning letter may be issued.
The US FDA has been issuing Form 483 observations and warning letters to Indian drug makers for failing to meet good manufacturing practice (GMP) standards laid down by it.
Indian generic exports account for roughly a fifth of the $119.1 billion spent on generic drugs in the US in the last calendar year.
Unlock a world of Benefits! From insightful newsletters to real-time stock tracking, breaking news and a personalized newsfeed – it's all here, just a click away! Login Now!
