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Zydus Lifesciences gets USFDA approval for acne treatment cream
KV Prasad Jun 13, 2022, 06:35 AM IST (Published)
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Summary
Zydus Lifesciences informed the stock exchanges that the production of the Tretinoin Cream will be carried out at the company’s Changodar facility in Ahmedabad, Gujarat.
Zydus Lifesciences Ltd announced on Friday, April 26, that it has obtained final approval from the United States Food and Drug Administration (USFDA) for the marketing of Tretinoin Cream USP 0.1% in the United States.
The cream, also known as Retin-A Cream, is primarily used for the treatment of acne and other skin diseases. The drug will be produced at Zydus group’s topical manufacturing facility in Changodar, Ahmedabad, the company informed the stock exchanges in a filing.
The pharma major informed the bourses that Tretinoin Cream USP, 0.1%, had annual sales of $54.8 million in the United States, as per the IQVIA data for the 12-month period ending February 2024.
Zydus Lifesciences said that with this nod from the USFDA, the group’s total approvals now stand at 394, having filed over 460 ANDAs since the inception of the filing process in FY 2003-04.
Earlier this week, Zydus Lifesciences announced that its injectable manufacturing site in Jarod, near Vadodara, Gujarat, received 10 observations from the US health regulator following an inspection. The inspection at the manufacturing facility was conducted from April 15 to April 23. In response, the company stated in a stock exchange filing that it would collaborate closely with the USFDA to address and respond to the observations.
On April 22, the pharma company also announced the launch of Mirabegron Extended-Release, 25 mg, tablets in the United States market. The tablet is used in the treatment of overactive bladder condition.
Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is a leading player in the pharmaceutical industry. The Ahmedabad-headquartered company’s portfolio includes pharmaceuticals, diagnostics, herbal medicines, skin care products and other over the counter drugs.
Shares of Zydus Lifesciences Ltd were trading at ₹946.8 apiece, down 0.44%, on the BSE at 2:58 pm.
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