Zydus Lifesciences Receives USFDA Approval for Acne Gel

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Zydus Lifesciences shares rose nearly 1% on September 21 after the company announced receiving final approval from the USFDA for Clindamycin Phosphate Gel USP, a skincare gel used to treat acne.

Clindamycin is an antibiotic that works by stopping the growth of bacteria and helps to decrease the number of acne lesions. It had annual sales of USD 37 million in the United States as per July 2023 figures of IQVIA MAT.

The drug will be manufactured at the group’s topical manufacturing facility at Changodar, Ahmedabad.

This is the latest in a series of approvals for Zydus Lifesciences from the USFDA. On September 19th, the company announced having received establishment inspection report (EIR) from the US drug regulator with ‘nil’ observations for its formulations manufacturing facility in Ahmedabad. This is expected to enable the pharma-company to receive approvals for pending abbreviated new drug applications (ANDA).

Brokerage Jefferies has a ‘hold’ rating on Zydus Lifesciences stock with the target price set at Rs 630 per share. The company’s management believes that it will continue to do well in its current business operations. New drivers for growth will be based on vaccines, biosimilars, and complex generics.

Zydus Lifesciences is engaged in the business of development, manufacturing, and marketing of a wide range of pharmaceutical products.


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