Zydus Lifesciences Gains Momentum Following Regulatory Nod
Zydus Lifesciences Shares witnessed a sharp rise on March 6, 2025, after securing final approval from the United States Food and Drug Administration (USFDA) to manufacture Dasatinib tablets. The company’s stock surged as much as 6.80% during intraday trading, reaching a high of Rs 947.95 per share.
The regulatory approval allows Zydus Lifesciences to produce Dasatinib tablets in multiple strengths, including 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. The medication is widely used in the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL).
In an official exchange filing, Zydus Lifesciences confirmed the USFDA approval, stating that the drug is equivalent to the reference-listed Sprycel tablets available in the same strengths. The development is expected to strengthen the company’s oncology portfolio and enhance its presence in the U.S. pharmaceutical market.
Dasatinib’s Market Potential and Manufacturing Plans
Dasatinib is a crucial therapy for patients diagnosed with Ph+ CML in the chronic phase and those who have developed resistance or intolerance to previous treatments, including imatinib. The drug is also used to treat patients with Ph+ ALL facing similar treatment challenges. With this approval, Zydus Lifesciences Shares are set to cater to a significant market demand in the oncology segment.
The company announced that the manufacturing of Dasatinib tablets will be undertaken at its Special Economic Zone (SEZ) facility in Ahmedabad. The decision aligns with Zydus Lifesciences’ strategy to expand its global footprint in high-value therapeutic areas.
According to IQVIA data from January 2025, annual sales of Dasatinib tablets in the U.S. reached approximately $1,807.7 million, underscoring the market potential of the drug. Zydus Lifesciences aims to capitalize on this opportunity by offering a cost-effective alternative to existing treatments.
The latest approval marks another milestone for Zydus Lifesciences, which has now secured 415 approvals from the USFDA and has filed 483 Abbreviated New Drug Applications (ANDAs) since initiating its filing process in FY 2003-04.
Zydus Lifesciences: A Global Healthcare Leader
Zydus Lifesciences, formerly known as Cadila Healthcare Ltd, is a prominent player in the global life sciences industry. Headquartered in Ahmedabad, Gujarat, the company specializes in the research, development, manufacturing, and marketing of healthcare solutions across various medical domains.
The company’s diverse portfolio includes finished dosage formulations, active pharmaceutical ingredients (APIs), biosimilars, vaccines, and consumer wellness products. Its therapeutic areas range from gastrointestinal and cardiovascular health to oncology, neurology, and women’s health.
With a strong presence in key markets, including the U.S., Europe, South Africa, Japan, and Brazil, Zydus Lifesciences continues to expand its international footprint. As of the latest data from BSE, the company’s market capitalization stood at Rs 91,028.96 crore, placing it within the BSE 200 category.
At 11:30 AM on March 6, 2025, Zydus Lifesciences shares were trading 1.93% higher at Rs 904.65 per share, while the BSE Sensex was marginally up by 0.02%, trading at 73,748.65 points.
