Zydus Lifesciences receives final approval from USFDA to market Tretinoin Cream

Zydus Lifesciences said on Friday it has received final approval from the United States Food and Drug Administration (USFDA) to market Tretinoin Cream USP, 0.1%. Shares of the company closed 0.4% lower on Friday.

Tretinoin cream, which is used to treat acne, had an annual sales of $54.8 million in the United States. Zydus Lifesciences said that the drug will be manufactured at the group’s topical manufacturing facility at Changodar, Ahmedabad.

Zydus Lifesciences informed the stock exchanges earlier this week that the USFDA conducted an inspection at the injectable manufacturing site situated at Jarod, near Vadodara. The inspection was conducted from April 15 to April 23, 2024, and closed with 10 observations, it said. The company stated it will closely work with the USFDA to address and respond to the observations in an expeditious manner.

The company recently announced that China has accepted the new drug application of its drug Desidustat tablets by China Medical System Holdings.

The firm said that the China Phase III trial of the product has demonstrated positive results. CMS International Development and Management, a wholly-owned subsidiary of China Medical System Holdings (CMS), obtained an exclusive license for the product from Zydus in 2020. Desidustat is being marketed by the group in India under the brand name Oxemia.

During the third quarter of fiscal year 2024 (FY24), the company reported a 6% increase in its operating revenue at ₹4,505.2 crore. Earnings before interest, tax, depreciation and amortisation (EBITDA) grew 15% year-on-year (YoY) to ₹1,102.4 crore. EBITDA margin for the quarter improved 200 basis points YoY to 24.5%.

Net profit rose 27% YoY to ₹789.6 crore during the quarter. Zydus had stated that capex for the quarter stood at ₹213.7 crore.

Shares of Zydus Lifesciences have gained over 37% since the beginning of the year. The stock has gained nearly 86% in the last one year.