Strides Pharma Science gets USFDA EIR for Puducherry facility
Bengaluru: Strides Pharma Science Limited has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its Puducherry manufacturing 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.
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"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," the company stated in a BSE filing.
Medical Dialogues team had earlier reported that the company had successfully completed the inspection carried out by the World Health Organization (WHO) at its Puducherry facility.
Read also: Strides Pharma Science successfully concludes WHO inspection at Puducherry facility
Strides is a global pharmaceutical company headquartered in Bengaluru, India. The Company mainly operates in the regulated markets and has an “in Africa for Africa” strategy and an institutional business to service donor‐funded markets. The Company’s global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi), and the United States (New York).
Read also: Strides Pharma Science Bangalore facility gets USFDA inspection closure
