FDA Closes Two-Year Inspection on Sun Pharma’s Injectables Manufacturing Facility

The US Food and Drug Administration (FDA) has issued an Establishment Inspection Report (EIR) to Sun Pharmaceutical Industries, a Mumbai, India-headquartered pharmaceutical company, for Sun Pharmaceutical’s injectables facility in Gujarat, India and has closed its inspection. With the issuance of this report, the product approval process will resume at the facility.

The company has been taking steps to remediate the facility since receiving a Warning Letter from the FDA in December 2015. The FDA issued a Warning Letter to Sun Pharma as a result of a September 2014 inspection for the company’s facility located at Halol, Gujarat in India, which manufactures injectable products for the US market. Following the September 2014 inspection, the FDA withheld future product approvals from the Halol facility.

“This is an important development for Sun Pharma. We remain committed to following the highest levels of quality and 24×7 cGMP compliance at all our manufacturing facilities globally,” said Dilip Shanghvi, Managing Director at Sun Pharma, in a June 12, 2018 company statement.

Source: Sun Pharmaceutical Industries


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