Sun Pharma Halol facility gets OAI status from USFDA
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).
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.
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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
