Strides Pharma Science gets USFDA EIR for Puducherry facility

Published On 2023-05-19 06:54 GMT | Update On 2023-05-19 06:55 GMT

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.

"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.

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).

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

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

Comments Policy

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Strides Pharma Science gets USFDA EIR for Puducherry facility

Similar News

Shilpa Pharma Lifesciences Unit-1 successfully completes GMP inspection from Brazilian regulatory authority

Lupin rolls out Nasal spray for rhinorrhea relief in US

Pfizer Told To Conduct Phase IV Trial of Abrocitinib in Indian Adolescents with Atopic Dermatitis

CBI Cracks Down on PCI Chief Montu Patel in College Bribery Scandal

Submit Full Adverse Event Data from Lenvatinib Phase IV Liver Cancer Trial: CDSCO Panel To Eisai Pharma

Over 700 bottles of Codeine Cough Syrup seized, 2 arrested

Massive Rs 1.2 crore Oxytocin seizure in Lucknow, 3 held

High-Alcohol Medicinal Preparations to Come Under Schedule H1: Govt Panel Approves Rule Change