Hot Pursuit     19-Jun-23
Zydus Lifesciences gets final USFDA nod for Minocycline Hydrochloride tablets
Zydus Lifesciences said that it has received final approval from US Food and Drug Administration (USFDA) for Minocycline Hydrochloride tablets.
The said drug is equivalent to reference listed drug product, Solodyn tablets. Minocycline Hydrochloride is used to treat moderate to severe acne in people 12 years and older. Minocycline belongs to a class of drugs known as tetracycline antibiotics. The product will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad (India).

According to IQVIA MAT April 2023, Minocycline Hydrochloride tablets USP, 55 mg, 65 mg, and 115 mg had annual sales of $0.7 mn in the United States.

As on 31 March 2023, the group has 372 approvals and has so far filed over 442 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company's consolidated net profit (from continuing operations) tumbled 27.55% to Rs 298.8 crore despite of 31.66% jump in total revenue from operations to Rs 5,010.6 crore in Q4 FY23 over Q4 FY22.

The scrip rose 0.86% to Rs 555 on the BSE.

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