Strides Pharma Science arm gets USFDA EIR for Alathur facility

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-08-20T11:25:45+05:30 | Updated On 20 Aug 2024 11:25 AM IST

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.

USFDA has determined that the inspection 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.

Strides Alathur facility caters to the U.S. and Other Regulated Markets. The facility manufactures tablets & capsules and supports several current and future products for the US markets.

Read also: Strides Pharma Science arm incorporates company in New Zealand

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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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751