Sun Pharma: USFDA classifies Halol facility as Official Action Indicated
Mumbai: Sun Pharma has announced that the company has received communication from the USFDA indicating that the Halol facility has been classified as "Official Action Indicated" (OAI). The OAI classification implies interalia that the USFDA may withhold approval of any pending product applications or supplements filed from this facility until the outstanding observations are resolved.
"The Company continues to manufacture and distribute existing products for the US market, thereby not likely to have any adverse impact on current business from the facility" Sun Pharma stated
"Sun Pharma continues to cooperate with the USFDA and will undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the Company's remedial action," Sun Pharma said
"Sun Pharma remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally", Sun Pharma added
Sun Pharma had previously stated in a communication dated December 13, 2019, regarding the USFDA inspection at the Company's Halol (Gujarat) facility from December 03-13, 2019 and issuance of Form 483 by USFDA with eight observations.
Sun Pharma is the world's fourth-largest specialty generic pharmaceutical company. A vertically integrated business and a skilled team enable it to deliver high-quality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Its global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities.
Sun Pharma fosters excellence through innovation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 7% of annual revenues in R&D.