Zydus Lifesciences Limited has achieved another milestone with the final approval from the United States Food and Drug Administration (USFDA) for its Ketoconazole Shampoo, 2%. This approval allows Zydus to manufacture and market the antifungal medication in the U.S. market.
About Ketoconazole Shampoo, 2%
Ketoconazole shampoo is widely used to treat dandruff, fungal infections, and other skin conditions. It is a generic version of Nizoral Shampoo, 2%, known for its effectiveness in treating scalp-related fungal issues. The product will be manufactured at Zydus’ topical manufacturing site in Changodar, Ahmedabad.
Market Potential
According to IQVIA MAT data (January 2025), the Ketoconazole Shampoo, 2% market in the United States had an annual sales value of USD 68.89 million. This approval positions Zydus to tap into a significant market segment in the U.S. pharmaceutical industry.
Official Statement and Regulatory Update
A formal communication from Zydus Lifesciences Limited confirmed the approval in an official press release dated March 10, 2025. The company has requested stock exchanges to bring this news to the attention of their members and the investor community.
It was also mentioned that the submission of the press release was delayed due to stakeholders being spread across different global time zones.
Zydus’ Regulatory Achievements
With this latest approval, Zydus now has 418 USFDA approvals and has filed 483 Abbreviated New Drug Applications (ANDAs) since it began its regulatory filing process in FY 2003-04. This underscores the company's commitment to expanding its portfolio and strengthening its presence in the U.S. market.
The USFDA approval for Ketoconazole Shampoo, 2% marks another success for Zydus in its journey to provide affordable and effective healthcare solutions. With a strong pipeline and continued regulatory achievements, the company is set to expand its global footprint further.
Disclaimer:
The information provided in this article is for informational purposes only and is based on the official press release issued by Zydus Lifesciences Limited. While efforts have been made to ensure accuracy, we do not guarantee the completeness or reliability of the details mentioned. Readers are advised to verify information from official sources before making any investment or business decisions. This article does not constitute financial, medical, or legal advice.
