India Pharma Outlook Team | Wednesday, 10 September 2025
Sun Pharmaceutical Industries declared that the US Food and Drug Administration (USFDA) has moved its Halol manufacturing plant in Gujarat to Official Action Indicated (OAI). The decision follows by the detailed examination.
The company told the stock exchanges that the OAI status indicates that the facility does not meet non-mutual CGMP requirements. The Halol site, a major location for India’s biggest drugmaker, has always been under the watchful eye of the authorities. This location is already on the import alert list that prohibits the US from receiving products from this site, unless it is for the drugs shortage cases, where the medicines are going to be used.
Upon recognition of the evolution, Sun Pharma once more assured the commitment to the regulators concerns. "CGMP is the umbrella under which the company operates, thus, high-quality drugs are delivered to the worldwide patients," it stated but didn’t stop there by adding that with the USFDA, they will continue to engage until the last hurdle is removed.
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The term OAI makes clear the point of serious non-compliance in the Halol facility. Looking from the perspective of the USFDA, this is wilklind a status indicating that a visit by a law enforcement officer may occur if further steps to solve the problem at the agency’s satisfaction are not carried out.
This is yet another hard blow to the Halol plant resulting from USFDA inspections. The site of the company is still to be compliant to be able to keep on selling the products in the American market which is a major concern for Sun Pharma.
