Last Updated on March 13, 2025 by The Health Master
USFDA Approval
The United States Food and Drug Administration approval (USFDA approval) has been granted to Zydus Lifesciences to manufacture and distribute Ketoconazole Shampoo, 2%.
This development paves the way for Zydus to enter a lucrative market, directly competing with the reference listed drug (RLD), Nizoral Shampoo, 2%.
This USFDA approval is a regulatory milestone as well as a strategic move into the high-demand dermatological market.
Targeting Common Skin Conditions
Ketoconazole shampoo is an antifungal medicine used to treat seborrheic dermatitis, which is commonly known as dandruff.
Ketoconazole is also effective against other fungal infections of the skin, e.g., tinea versicolor.
The Ketoconazole shampoo having 2% concentration is widely known for its safety and efficacy.
This approval allows Zydus to provide a more accessible and potentially cost-effective alternative for patients suffering from these prevalent conditions.
Key Applications:
- Dandruff (Seborrheic Dermatitis)
- Tinea Versicolor
- Other fungal skin infections
Manufacturing in Ahmedabad
The manufacturing of Ketoconazole shampoo will be done at Zydus Lifesciences’ manufacturing facility situated in Changodar, Ahmedabad, Gujarat.
This manufacturing facility has advanced manufacturing techniques that adhere to stringent quality control standards laid down by the regulatory authorities.
Q: What is the use of Ketoconazole shampoo?
A: Ketoconazole shampoo is mainly used to treat dandruff and other fungal infections of the skin.
Q: Where will Zydus Lifesciences manufacture the shampoo?
A: At their topical manufacturing site in Changodar, Ahmedabad.
Q: How large is the market for Ketoconazole shampoo in the US?
A: According to IQVIA MAT January 2025, the annual sales are $68.89 million.
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