Sun Pharma Halol facility gets OAI status from USFDA

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-09-11 11:30 GMT   |   Update On 2025-09-11 11:30 GMT
Advertisement

Mumbai: Sun Pharma has received "Official Action Indicated" (OAI) classification from the U.S. Food and Drug Administration (USFDA) for the Company's Halol facility.

 A Good Manufacturing Practices (GMP) inspection was conducted from 02 June to 13 June 2025.

This means the FDA considers the facility to be not fully compliant with regard to certain current good manufacturing practices (CGMP).

Advertisement

The Halol facility is under Import Alert, resulting in the refusal of shipments from the facility into the US, barring certain exemptions due to drug shortage, until the facility becomes fully compliant with FDA and CGMP standards.

"Sun Pharma remains committed to working with the FDA and maintaining CGMP standards at all of its facilities to provide high-quality medicines to patients globally," the company stated in a BSE filing.

Read also: Sun Pharma Gets CDSCO Panel Nod for Phase IV Trial of Esomeprazole Dual Release Tablets 80 mg

Sun Pharma is a specialty generics company with a presence in specialty, generics and consumer healthcare products. Sun Pharma’s global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. Its manufacturing facilities are spread across six continents.

Read also: Sun Pharma Gets CDSCO Panel Nod to Manufacture, Market Enzalutamide for Prostate Cancer

Tags:    

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.

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 .

Similar News