India’s Sun Pharmaceuticals said the FDA has cleared its manufacturing facility at Dadra that had been cited with a warning letter from the agency earlier this year for violations of good manufacturing standards.
The company said in a notification to the Bombay Stock Exchange and reported by Livemint, that the company received an Establishment Inspection Report from the FDA for the plant that was inspected in April, meaning the facility is cleared.
During that inspection, the FDA found 11 quality issues that included incomplete laboratory records, failure to create accurate duplicates of key records and improper investigation of drug batches that did not meet specifications.
The inspection of the Dadra plant came a month after the FDA lifted a 2013 import alert on Sun Pharma’s manufacturing plant at Mohali in Punjab. Sun inherited that facility when it acquired Ranbaxy Labs in 2015.
Sun’s Halol plant in Gujarat continues to remain under FDA scrutiny, as do several other facilities the company picked up in the Ranbaxy deal.
The company has been hindered by the warning letters, which has put pressure on Sun’s bottom line. Earlier this year the company reported sales for fiscal 2017 at about $4.7 billion, up 9%. However, in the U.S., revenues were off 34% to $381 million for its fourth quarter ended March 31. The U.S. shortfall contributed to an 8% fall in revenues across the board for India’s largest drugmaker. Sun’s profit was down 14% to $189.6 million in the quarter.