Zydus Lifesciences gains on USFDA’s final approval for skin-care topical

“We have received final approval from the USFDA for Clindamycin Phosphate Gel USP. Clindamycin is an antibiotic which works by stopping the growth of bacteria and helps to decrease the number of acne lesions,” Zydus Lifesciences said in a regulatory filing at the exchanges.

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Zydus Lifesciences shares were trading a percent higher in the morning trade on September 21 after the pharma-company announced having received final approval from the United States Food and Drug Administration (USFDA) for a skincare gel used to treat acne.

“We have received final approval from the USFDA for Clindamycin Phosphate Gel USP. Clindamycin is an antibiotic which works by stopping the growth of bacteria and helps to decrease the number of acne lesions. It had annual sales of USD 37 mn in the United States as per July 2023 figures of IQVIA MAT,” the company said in a regulatory filing on September 20th.

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

Zydus Lifesciences on September 19th had announced having received establishment inspection report (EIR) from the US drug regulator with ‘nil’ observations.  The company said they had received for  this EIR for its formulations manufacturing facility in Ahmedabad. This is expected to enable the pharma-company now to receive approvals for pending abbreviated new drug applications (ANDA).

At 9.30 am on the NSE, the Zydus Lifesciences stock was quoting at Rs 630.55 apiece, up Rs 5.80, or 0.93 percent.

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In its results for the April-June quarter, the company reported a 26.19-percent YoY (year-on-year) increase in revenue from operations at Rs 5,140 crore. Net profit for the quarter was up 96.87 percent YoY at Rs 1,134 crore. The operating profit margins for the quarter expanded by 900 basis points on a yearly basis to 29 percent.

Brokerage Rating

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. Especially new chemical and biological entities apart from complex generics will be the growth drivers for its business in US,” it said.

Zydus Lifesciences is engaged in the business of development, manufacturing, and marketing of a wide range of pharmaceutical products, including generic drugs and active pharmaceutical ingredients (APIs).

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