On April 11, 2025, shares of Cipla Pharmaceuticals surged by 5% following the announcement that the company secured approval from the U.S. Food and Drug Administration (USFDA) for its cancer drug, Paclitaxel Protein-bound Particles for Injectable Suspension. The approval was granted for the Abbreviated New Drug Application (ANDA) submitted for this product, which is a generic version of Bristol Myers Squibb’s Abraxane. This news sent Cipla’s stock to an intraday high of ₹1,488.80, reflecting a strong market response to the company's latest development.
The USFDA’s approval, granted on April 10, 2025, marks a significant milestone for Cipla, as the company plans to launch the product in the first half of fiscal year 2025-2026. Paclitaxel is widely used in the treatment of various cancers, including metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer (NSCLC), and metastatic adenocarcinoma of the pancreas. The announcement has been seen as a positive surprise for investors, as noted by brokerage firm Elara Capital, which had anticipated a later approval timeline.
At 11:30 a.m. on the same day, Cipla’s shares were trading at ₹1,452.55, nearly 2.6% higher than its previous close of ₹1,415.60. The current market capitalization of Cipla stood at ₹1,19,857.01 crore, indicating a robust position in the market. Analysts have been optimistic about Cipla’s growth prospects, with 24 out of 37 analysts rating the stock as a 'Buy'.
In addition to the recent approval, Cipla's financial performance has been impressive. For the third quarter of the fiscal year 2024-25, the company reported revenue from operations of ₹7,073 crore, a 7% increase year-on-year from ₹6,604 crore. The net profit surged by 49%, reaching ₹1,571 crore compared to ₹1,056 crore in the same quarter last year. The earnings before interest, tax, depreciation, and amortization (EBITDA) margin also improved to 28.1%, up from 26.3% in the same quarter of the previous year.
Segment-wise, Cipla's revenue showed varied performance across regions. In India, revenue grew by 10%, reaching ₹3,146 crore, driven by strong demand in respiratory and urology therapies. However, revenue from North America declined by 1% year-on-year, totaling $226 million. Emerging markets and Europe reported a 20% year-on-year revenue growth, while South Africa's revenue increased by 21%.
In a regulatory filing, Cipla confirmed, “We hereby notify that the company has received final approval from the United States Food and Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) submitted for Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound), 100 mg/vial, Single-Dose Vial.” This product is expected to be a significant addition to Cipla's portfolio, as it is an AB-rated generic therapeutic equivalent of Bristol Myers Squibb’s Abraxane.
Looking ahead, analysts predict that Cipla could generate significant revenue from the new product, estimating potential earnings of up to $50 million from the U.S. market, despite existing competition from other generic players. The approval comes at a crucial time for Cipla, which has been focusing on expanding its product offerings and maintaining its leadership in the pharmaceutical sector.
Furthermore, in March 2025, Cipla entered into an exclusive licensing deal with Formosa Pharmaceuticals to commercialize APP13007, showcasing its commitment to innovation and growth in the pharmaceutical landscape.
As for investment recommendations, the consensus from analysts on Trendlyne indicates a favorable outlook for Cipla’s shares, with 46% suggesting to buy, 22% recommending to hold, and only 3% advising to sell. The average target price for Cipla’s shares is estimated at ₹1,707.30, representing a potential upside of 17.55% from the recent trading price.
In response to concerns about potential tariffs on pharmaceutical imports, Cipla’s CEO, Umang Vohra, has previously cautioned against making large infrastructure investments based solely on short-term trade policies. He emphasized that such tariffs should not dictate the commercial strategies of Indian pharmaceutical companies.
With its strong financial performance and promising product approvals, Cipla continues to position itself as a key player in the global pharmaceutical market. The company’s commitment to providing affordable healthcare solutions, especially in emerging markets, remains a cornerstone of its operations.
As Cipla prepares to launch its new cancer treatment in the U.S. and navigates the complexities of international trade and market dynamics, investors and healthcare professionals alike will be watching closely to see how this development impacts the company’s trajectory in the coming years.
