Shares of Zydus Lifesciences Ltd were trading in the green and 1% higher on 12 June after the company secured the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA).
In its regulatory filing, the company said, “Zydus Lifesciences has received the Establishment Inspection Report (EIR) report from the USFDA for the inspection conducted at its API manufacturing facility located at Ankleshwar.”
This plant was inspected between 10 and 14 March 2025, and the inspection was classed as No Action Indicated (NAI). The USFDA has “closed” this inspection, it added.
Earlier this month, the company made a strategic foray into the worldwide biologics contract development and manufacturing organization (CDMO) market, acquiring two biologics manufacturing sites in the United States from Agenus Inc. and Agenus West LLC.
The transaction includes a $75 million upfront payment, as well as a potential payment of up to $50 million over three years if certain revenue goals are met. In addition, the company gained approval from the US health agency to market medicine for the treatment of irritable bowel syndrome with diarrhoea in adults.
The company has acquired preliminary approval from the US Food and Drug Administration (USFDA) for Rifaximin Tablets (550 mg), according to a regulatory filing. Rifaximin tablets are used to treat irritable bowel syndrome with diarrhoea (IBS-D) in adults.
At 11:43 am, the shares of Zydus Lifesciences were trading 0.17% higher at Rs 980.45 on NSE.
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