Ipca Labs undergoes crucial US FDA inspection at Ratlam facility amid import alert

Pharmaceutical company Ipca Laboratories, is currently undergoing a US FDA inspection at its API facility in Ratlam. This inspection holds significant importance for Ipca as the facility has been under an import alert since FY15, resulting in a halt in the company's supplies to the United States. Three of Ipca's major facilities, at Ratlam, Silvassa, and Pithampur, remain under import alert.

In April 2023, the US FDA conducted an inspection of Ipca's formulation facility in Silvassa, which resulted in the company receiving three observations in Form 483. The ongoing inspection of the Ratlam facility is even more crucial for Ipca, especially considering its recent acquisition of a 34 percent stake in Unichem Labs and the open offer made to acquire an additional 26 percent stake.

A report by Motilal Oswal in May 2023 highlighted that Ipca's in-house manufacturing of API (active pharmaceutical ingredients) for most of its approved ANDAs (abbreviated new drug applications) makes regulatory compliance at the Ratlam facility pivotal for any recovery in the US generics business.