Strides Puducherry facility receives Establishment Inspection Report from USFDA

Strides Pharma Science Limited (Strides or Company) has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its Puducherry manufacturing facility (Facility), stating the inspection conducted between February 20-24, 2023 has been closed. The USFDA has classified the facility from Official Action Indicated (OAI) to Voluntary Action Indicated (VAI).

The USFDA had classified Strides Puducherry facility as OAI in May 2019 followed by issuing a warning letter to this site in July 2019.

Strides Puducherry facility caters to the U.S., other regulated markets, and institutional businesses and produces finished dosage formulation products across multiple dosage formats. Consequent to this reclassification by the USFDA, the filed ANDAs from this facility will now start receiving approvals.

The Company remains committed to the highest standards of compliance and will continue to focus on manufacturing high-quality pharmaceutical products for the Global markets.

Shares of Strides Pharma Science Limited was last trading in BSE at Rs. 359.40 as compared to the previous close of Rs. 370.95. The total number of shares traded during the day was 22866 in over 987 trades.

The stock hit an intraday high of Rs. 373.25 and intraday low of 355.05. The net turnover during the day was Rs. 8345777.00.

Source : Equity Bulls

Keywords

StridesPharmaScience INE939A01011 USFDA EIR Puducherry ManufacturingFacility