Shares of Zydus Lifesciences were trading in the red and 5% lower on 24 April after the company’s injectables production plant received ten observations from USFDA.

In its regulatory filing, the company said that the US Food and Drug Administration (FDA) conducted an inspection at its injectables production plant in Vadodara, Gujarat, between 15 April and 23 April and concluded the inspection with ten observations. 

The company faces delays in drug launches and will not be allowed to submit new drug applications from the facility unless it addresses issues raised by the FDA.

In an exchange filing, the company stated that it would work closely with the FDA to address and respond to the observations as soon as possible. 

Earlier this week, the company announced launching the generic version of the bladder control medication Mirabegron in the US, improving market sentiments. 

The company was among the first providers to qualify for 180 days generic medication exclusivity.

According to IQVIA data (IQVIA MAT February 2024), the US annual sale of mirabegron, both 25 mg and 50 mg, was $2.42 billion.

During the exclusivity period, Incred projects that Zydus Lifesciences can generate an estimated $75–80 million from this product opportunity, or around Rs 4 per share in EPS.

At 1:45 pm, the shares of Zydus Lifesciences were trading 2.33% lower at Rs 937 on NSE.