Sun Pharma site hit with second Form 483 in 3 years
An Indian pharma with a manufacturing site in Gujarat has been slapped with a Form 483 from the FDA after inspections that ended yesterday resulted in 10 observations.
The inspection was carried out from April 26 to May 9 at Sun Pharma’s Halol facility in Gujarat, and shares were down 3% following the release of the news. The details of the observations have not yet been revealed.
“The company is preparing the response to the observations, which will be submitted to the US FDA within 15 business days,” Sun Pharma said in a letter to the National Stock Exchange of India. “The company is committed to addressing these observations promptly. The company remains committed to working closely with the US FDA and continues to enhance its GMP compliance on an ongoing basis.”
An analyst told Business-Standard that the site is responsible for roughly 5-6% of the company’s turnover and that the site has become smaller over the years.
Sun was forced to recall 100,000 bottles of its generic erectile dysfunction tablet back in October. It also pulled more than 22,000 packs of extended-release loratadine-D tablets. The site got hit with a Form 483 back in December 2019, when it was slapped with eight observations.
Just in March, the pharma was forced to pay a big settlement in lieu of claims of misconduct against its Ranbaxy generics unit. The pharma agreed to shell out $485 million to settle the class-action suit, without admitting to the charges. Charges accuse Ranbaxy of including false information in its applications to make generics of Genentech’s antiviral drug Valcyte, Novartis’ Diovan — which is used for blood pressure — and Nexium, the acid reflux drug from Pfizer. As a result of the first approvals, the company gained 180 days of exclusivity on the market.