US FDA plant observations at Cipla cause 6-month delay in product launches: CEO

The US Food and Drug Administration (US FDA) observations at Cipla's plants in Pithampur and Goa are delaying the launch of products by almost six months, the management said in a press meet following its Q2 results.

"We are delayed by six months, from where we could launch, to the time we will," said MD and Global CEO Umang Vohra while addressing journalists. He mentioned that the process of shifting the manufacturing of the products to other plants has been ongoing for the past 4-5 months.

The biggest product being manufactured at the Pithampur facility is Advair. "We are in the process of shifting it to Hauppauge in Long Island," Vohra stated. Advair, which is used in the treatment of asthma and chronic obstructive pulmonary disease, is expected to have significant revenue potential, with analysts expecting it to bolster Cipla's financials.

The drug commands a market size of $700 million, and Cipla is leading the race to launch the first generic version, despite the delays. Only select generic players have a presence in the respiratory space, with the most active ones being Cipla, Lupin, Teva, Vitaris, and Hikma. Although Lupin is also in the race to launch gAdvair, brokerage firm Jefferies doesn't expect it to launch the drug anytime soon, leaving Cipla with an open field.