Strides Pharma Science arm gets USFDA EIR for Alathur facility
Bengaluru: Strides Alathur Private Limited, a wholly-owned subsidiary
of Strides Pharma Science Limited has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its formulations facility at
Alathur, Chennai thereby successfully concluding the Good Manufacturing Practices (GMP)
inspection conducted between April 1-5, 2024.
classification of this facility is “Voluntary Action Indicated” (VAI). VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
manufactures tablets & capsules and supports several current and future products for the US
markets.
Strides, a global pharmaceutical company headquartered in Bengaluru, India, is listed on the BSE Limited (532531) and National Stock Exchange of India Limited (STAR). 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), Italy (Milan), Kenya (Nairobi), and the United States (New York). The Company focuses on “difficult to manufacture” products sold in over 100 countries.
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