The US drug regulator has classified the pharma major's Halol facility in Gujarat as Official Action Indicated (OAI).
In an exchange filing made on Sunday 29 March 2020, Sun Pharmaceutical Industries said that OAI classification implies that the United States Food and Drug Administration (USFDA) may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved. There are 19 abbreviated new drug applications (ANDAs) and 2 new drug applications (NDAs), which were filed from the Halol facility, currently awaiting approval for the US market.
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. US supplies from Halol, as of now, contribute approximately 3-4% of the company's consolidated revenues .
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. It remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally.
On 13 December 2019, the company had informed about the inspection conducted by the US drug regulator at its Halol (Gujarat) facility from 3 to 13 December 2019 and issuance of Form 483 by USFDA with eight observations.
Shares of the drug maker ended 0.12% lower at Rs 338.15 on Friday.
Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.
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