Shares of Zydus Lifesciences Ltd were trading in the red and 3% lower on 18 June after the company’s injectable manufacturing facility in Ahmedabad, Gujarat received the Official Action Indicated (OAI) status from the US Food and Drug Administration (USFDA). 

In its regulatory filing, the company said that the US regulator has granted a teleconference Regulatory Meeting for discussing all the implemented and proposed actions. 

The USFDA conducted an inspection between 18 March to 27 March at its injectables manufacturing facility, Pharmez Special Economic Zone, Matoda, Gujarat. 

The company added that it will work closely with the agency to resolve this regulatory status at its facility. 

On 14 June, the company secured tentative approval from the USFDA to market Azilsartan Medoxomil and Chlorthalidone Tablets, 40 mg/12.5 mg and 40 mg/25 mg. Azilsartan Medoxomil and Chlorthalidone is an angiotensin II receptor blocker and a thiazide like diuretic combination product, which is used to treat high blood pressure (hypertension) to lower blood pressure. 

The Azilsartan Medoxomil and Chlorthalidone tablets will be manufactured at its formulation manufacturing facility in Ahmedabad SEZ – II. 

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

At 11:26 am, the shares of Zydus Lifesciences were trading 2.40% lower at Rs 1,082.90 on NSE.