Shares of Zydus Lifesciences were trading in the red and 3% lower on 19 July after the company announced that its Jarod unit received OAI classification from the USFDA.  

The US Food Food and Drug Administration (USFDA) conducted an inspection at the company’s Jarod injectables manufacturing facility between 15 April and 23 April. The US regulator concluded the inspection by issuing a Form 483 with ten observations. However, the observations issued by the USFDA were not rectified by the company, leading to the ‘Official Action Indicated’ (OAI) classification of the company’s Jarod unit. 

The OAI classification is the most stringent among the three issued by the US FDA. A facility is classified as OAI when serious compliance issues are identified that, if unresolved, could result in export, regulatory, or administrative restrictions.

To receive clearance, Zydus Lifesciences must address the concerns raised by the FDA and undergo a re-inspection before it can launch or file new drugs from the facility.

Moreover, the US health authorities have given the pharmaceutical company final approval to market Zituvimet XR (sitagliptin and metformin hydrochloride) extended-release tablets.

With this, the company now has approval for all three NDAs of Sitagliptin (base) and combination franchise. The company added, “Notably, all the three NDAs achieved first-cycle approval (FCA).”

Zituvimet XR extended-release tablets, which include sitagliptin and metformin hydrochloride, are recommended as a dietary and exercise supplement for individuals with type 2 diabetes mellitus in order to improve glycemic control.

The drug will be manufactured at Zydus Lifesciences’ formulation manufacturing facility in the Ahmedabad Special Economic Zone.

At 2:54 pm, the shares of Zydus Lifesciences were trading 3.64% lower at Rs 1,142.50 on NSE.