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U.S. FDA Flags Operational And Procedural Lapses At Cipla’s Goa Unit


Goa, the brokerage said, accounted for about $60 million (Rs 475 crore) in sales. This included products such as gPulmicort (asthma), Cipla’s second-largest product in the market currently. “We, however, think sales contribution from the Goa site has reduced since, due to price erosion in the base portfolio and site transfer of products like gPulmicort to Indore. The company has also suspended operations of some sterile lines at the site following the September 2019 inspection.”

Cipla has not shared the number of pending ANDAs from the site, said Nomura. But the management mentioned that gAbraxane (breast cancer) was one key filing from the site. The company might be making site transfer efforts due to uncertainty on timeline for clearance of the Goa site. Given the outcome of the recent inspection, which included three repeat observations and high sensitivity around contamination in sterile products, the site may remain classified under “official action initiated”.

The drugmaker has yet to respond to BQ Prime’s emailed queries on the implications of the observations and their impact on future approvals and launches. It’s also yet to comment on the steps being taken to address these issues and the expected timelines.

Since Aug. 26, shares of Cipla have gained 4.5% compared with a 1.4% rise in the benchmark Nifty 50.





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