Cipla's major drug launches hit new delays as regulatory hurdles persist

Cipla released better-than-expected Q2 numbers on October 29.

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26 Aug, 2025 12:21

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Drugmaker Cipla continues to struggle with regulatory challenges which have caused delays in the launch of two key drugs--respiratory medication Advair and chemotherapy drug Abraxane- yet again. The two crucial drugs, originally targeted for a launch in FY25 have faced multiple delays as Cipla's manufacturing facilities at Pithampur and Goa got embroiled in regulatory hurdles.

In Cipla’s Q2 earnings call, MD and Global CEO Umang Vohra provided updates on the expected launch timelines for Advair and Abraxane. Vohra projected a mid-FY26 launch for Advair, while Abraxane’s timeline remains tied to regulatory clearance of Cipla’s Goa facility, which is designated to produce the drug.

As for Advair, the product will now be filed from Cipla's Hauppauge plant in Long Island, US, instead of the originally planned Pithampur unit. This was after Cipla's Pithampur unit got a warning letter from the US Food and Drug Administration. It was the regulatory challenges at the Pithampur unit that led to the delay in Advair's launch in the first place.

The drug is seen as one of the blockbuster launches for Cipla, pinned on the fact that it commands a market size of $700 million, and the drugmaker is leading the race to launch the first generic version, despite the delays.

Meanwhile, the prolonged regulatory hurdles at Cipla's Goa plant have continually pushed back the launch of Abraxane, giving competitors a chance to gain ground. Cipla's Goa facility, which was to manufacture Abraxane, is currently under USFDA's 'Official Action Indicated' status.

Recently, a China-based pharmaceutical firm received approval for Paclitaxel, a generic version of BMS’s Abraxane, making it as the first interchangeable variant. This development could allow the competitor to capture a sizable market share and drive prices down, potentially undermining Cipla's lead, according to Citi.

Also Read | Citi warns further regulatory delays at Goa facility could erode Cipla's Abraxane opportunity

Citi also noted that any significant price erosion before Cipla’s launch could severely reduce Abraxane's revenue potential for the company.

Adding to the woes, Cipla is also facing supply challenges for its tumor drug Lanreotide which it recently launched in the US. Vohra, in the earnings call, also stated anticipating continued pressure on Lanreotide sales in Q3 as well. However, Vohra further clarified that sales were to see a sharp recovery from Q4 aided by improved capacity on the back of capacity expansion from Cipla's partner.

According to IQVIA (IMS Health), Lanreotide generated around $898 million in US sales for the 12 months ending March 2024.

On October 29, shares of Cipla settled 2 percent lower despite the company's reporting better-than-expected Q2 numbers.

Also Read | Cipla Q2 net profit jumps 15% on-year to Rs 1,303 crore, beats estimate

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