Sun Pharma’s Dadra manufacturing unit gets US FDA clearance
Mumbai: Sun Pharmaceutical Industries Ltd, India’s largest drug maker, said on Wednesday that the US Food and Drug Administration (FDA) has cleared its manufacturing facility at Dadra, which was issued a Form-483 by the regulator earlier this year due to violation of good manufacturing practices (GMP).
The US FDA issues a Form-483 if its investigators spot any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related laws.
The company has received an Establishment Inspection Report (EIR) from the US FDA for its Dadra unit, which means that the April inspection is closed, Sun Pharma said in an exchange filing.
During an inspection in April, the US FDA found 11 quality lapses at the Dadra unit, which included incomplete laboratory records, failure to create accurate duplicates of key records, and improper investigation of drug batches that did not meet specifications.
In March, the US FDA had decided to lift an import alert on Sun Pharma’s manufacturing plant at Mohali in Punjab. The import ban was issued in 2013. The Mohali plant came into the Sun Pharma fold when it acquired Ranbaxy Laboratories Ltd in 2015.
However, the company’s plant at Halol in Gujarat continues to be under a warning letter from the US regulator. Other units of Ranbaxy at Dewas in Madhya Pradesh, Paonta Sahib in Himachal Pradesh and Toansa in Punjab are also under US FDA’s import alert.
On Wednesday, shares of Sun Pharma ended down 0.3% at Rs525.80 on the BSE, while the benchmark Sensex index closed down 0.3% at 31,833.99 points.