Prominent Pharma Player Zydus Lifesciences Limited made a significant announcement on Friday, April 26th disclosing that it has secured final approval from the United States Food and Drug Administration (US FDA) for the marketing of Tretinoin Cream USP 0.1% in the United States. This cream, commonly recognised as Retin-A Cream, is primarily utilised for treating acne and various skin diseases. The Manufacturing facility is in Changodar, Ahmedabad, as per the company’s filing with the stock exchanges.
Also Read | Sun Pharma’s Dadra Facility Classified as Official Action Indicated by USFDA
Expanding Market Presence
The USFDA approval brings the total number of approvals for this group to 394, making it one of the most robust in the pharmaceutical industry. According to Zydus Lifesciences annual sales data for IQVIA for the 12 months ending in February 2024, USP (0.1%) generated USD 54.8 million in annual sales. Since the filing of the first Abbreviated New Drug Application [AANDA] in the fiscal year 2003-04 (FY 2003-04), Zydus Lifesciences has submitted more than 460 AANDAs.
Addressing Regulatory Concerns
However, earlier this week, the company encountered regulatory challenges when its injectable manufacturing site in Jarod, near Vadodara, Gujarat, received 10 observations from the US health regulator post-inspection. The inspection, conducted from April 15 to April 23, prompted Zydus Lifesciences to reassure stakeholders through a stock exchange filing that it would work closely with the USFDA to address and respond to the observations promptly.
Also Read | Aurobindo Pharma’s Injectable Facility Receives Observations from US FDA
Recent Market Ventures
In further developments, Zydus Lifesciences unveiled the launch of Mirabegron extended-release, 25 mg, tablets in the United States market on April 22. These pills are indicated to treat overactive bladder conditions, which is another strategic move by the company to diversify product offerings and meet emerging medical needs.
Company Profile
Rewind the time and you remember, it was then known as Cedilla Healthcare Limited and has now been rebranded as Zydus Lifesciences Limited. Its head office is in Ahmedabad and it also has a wide range of products which includes drugs and medicines, diagnostics, herbal medicine, and cosmetics to name a few.
