Zydus Lifesciences Limited has informed the Exchange regarding a press release dated May 23, 2025, titled "Zydus receives final approval from USFDA for Isotretinoin Capsules USP, 10 mg 20 mg, 25 mg, 30 mg, 35 mg and 40 mg".
ZYDUSLIFE · price
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Awaiting price reaction for this filing.
Zydus Lifesciences has received final approval from the USFDA to market Isotretinoin Capsules USP in six strengths — 10 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg. The drug is used to treat severe nodular acne and is a generic equivalent of Absorica® Capsules. The product will be manufactured at the company's Moraiya facility in Ahmedabad. Isotretinoin capsules have annual US sales of USD 115.4 million (IQVIA MAT March 2025), representing a sizeable market opportunity. Zydus now holds 427 cumulative ANDA approvals and has filed 492 ANDAs since FY 2003-04.
Positive — adds a new revenue-generating product to Zydus's US generics portfolio targeting a USD 115+ million market. Strengthens the company's US business pipeline and supports long-term growth in the lucrative dermatology segment.