Strides Pharma's Chennai Facility Receives USFDA Approval

19 Aug 2024 , 03:21 PM

Strides Pharma Science Ltd announced that its subsidiary, Strides Alathur Private Ltd, received an Establishment Inspection Report (EIR) from the USFDA for its Alathur facility in Chennai.

The EIR follows a successful Good Manufacturing Practices (GMP) inspection conducted by the USFDA from April 1-5, 2024.

The Alathur facility received a “Voluntary Action Indicated” (VAI) classification, meaning that while issues were noted, they do not require regulatory action and can be voluntarily addressed by the company.

The Alathur facility is key to Strides’ global operations, especially in the US and other regulated markets, specializing in the production of tablets and capsules.

On May 22, 2024, Strides Pharma received USFDA approval for the generic version of Sucralfate Oral Suspension, equivalent to Carafate 1gm/10mL by AbbVie, used to treat stomach ulcers.

In Q1 FY2024-25, Strides Pharma reported a net profit of ₹68.3 Crore, a significant recovery from a loss of ₹9.4 Crore in the same quarter the previous year.

The company’s revenue increased by 16.6% to ₹1,087.5 Crore in Q1 FY25, compared to ₹929.9 Crore in the same period last year. Strides Pharma’s EBITDA rose by 28.7% to ₹217 Crore, up from ₹168.6 Crore in the corresponding quarter of the previous year. US revenues reached an all-time high of $70 million in Q1 FY25, marking a 24.5% year-over-year growth from $65 million.