The US Food and Drug Administration (USFDA) has issued Form-483 with zero observations for Solara Active's Cuddalore facility in Tamil Nadu. The US FDA inspected facility between July 31 and August 4, 2023.

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Shares of Solara Active Pharma Sciences Ltd rallied nearly 4 percent in Monday's trade. The stock opened at Rs 389 apiece and went on to hit an intra-day high of Rs 403 on the NSE. On a year-to-date basis, Solara shares have fallen 9 percent while it gained 10 percent in the last one year.

"We would like to update you that Solara Active Pharma Sciences Limited (Solara) has successfully completed the inspection carried out by the US Food and Drug Administration (US FDA or Agency) at its Cuddalore facility (Tamil Nadu)," the drug firm said in a statement.

The Agency, with its designated investigators, inspected the Cuddalore facility between July 31, 2023 – August 4, 2023. The inspection established that the facility is in an “Acceptable State of Compliance” with Zero Form 483 inspectional observations from the Agency, it said.

With this successful inspection outcome, the current inspection classification of Cuddalore site shall be reinstated to NAI (No Action Indicated), the company informed the stock exchanges.

"“We are happy with the outcome of the FDA inspection with Zero 483 inspectional observations. This is the third consecutive successful regulatory inspections outcome (USFDA, EU-GMP and WHO-GMP inspections) at our Cuddalore site and gives us confidence in our quality systems and oversight of our manufacturing infrastructure. The result of these inspections demonstrates our commitment to regulatory excellence at our global manufacturing sites and our relentless focus on world-class quality and compliance," said Poorvank Purohit (MD and CEO).

This facility has also successfully completed the regulatory inspections carried out by the World Health Organization (WHO) between January 23 – 26, 2023 and EU-GMP Inspection carried out jointly by the “State Institute for Drug Control (SUKL), Ministry of Health of the Czech Republic” and “National Authority of Medicines and Health Products (INFARMED), Portugal” between February 07 – 09, 2023.

The Cuddalore API site is a multi-product facility, caters wide range of APIs to various regulated markets across the globe, including US, Europe, Japan and other markets.

According to USFDA, the Form 483 is issued to a firm management if there are violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The FDA Form 483 notifies the company’s management of objectionable conditions.

First Published:Aug 7, 2023 11:06 AM IST