Solara Active Pharma Science, Cuddalore facility has been issued Form-483 with zero observation from the USFDA (the United States Food and Drug Administration).

The USFDA inspected the facility between 31 July – 4 August 2023 and established that the facility is in an “Acceptable State of Compliance”.

The company said they had completed the inspection carried out by the USFDA at its Cuddalore facility in Tamil Nadu.

The company’s Cuddalore facility is a multi-product facility that caters to a wide range of APIs in various regulated markets, including the US, Japan, and Europe.

MD and CEO Poorvank Purohit said, “We are happy with the outcome of the FDA inspection with Zero 483 inspectional observations. This is the third consecutive successful regulatory inspection outcome 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,”

The Cuddalore facility has also completed the regulatory inspections carried out by World Health Organisation (WHO), 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 7-9 February 2023.

At 2:00 pm, the share of Solara Pharma was trading at Rs 392.50 or 0.18% below its previous close of Rs 393.20 on NSE.