The US Food and Drug Administration has issued a Form 483 and the drugmaker is preparing its response to the observations, Sun Pharma said in a statement on Friday without providing details. The response will be submitted within 15 days and the company “continues to enhance its good manufacturing practices compliance,” it said.
The regulator’s inspection of the facility from February 12-23 comes as profit at India’s biggest drugmaker fell 75% in the quarter through December dragged down by slowing sales of generic medicines in the US. While Sun has been hurting from the deterioration in US generic drug prices that are roiling the whole industry, sanctions over manufacturing deficiencies have halted new product approvals from its plant in Halol.
While details of the observations are needed to evaluate how serious they are, the only positive is that the number has come down to three from nine earlier, Ranjit Kapadia, an analyst at Centrum Broking, said by phone from Mumbai.
Shares of Sun rose 5.6% as of 3:19pm in Mumbai, compared with the 1% gain in the benchmark S&P BSE Sensex.
Sun received a warning letter from the US regulator in December 2015 following an inspection at its Halol facility. A reinspection in 2016 produced 14 pages of new observations, including poorly designed tests and tardiness reporting results. While a warning letter does not prevent drugs already approved being shipped from a facility, it does place restrictions on new ones.
Sales in the US accounted for one-third of its total in the quarter ended December, from about half two years earlier.
The FDA’s website says that a Form 483 is issued to a company when inspectors note any conditions that may constitute violations of the Food, Drug and Cosmetic Act. The agency also says that the report does not constitute a final decision of whether any regulations were violated. The FDA considers company responses and other documents before deciding what further action, if any, is appropriate after a Form 483. -With assistance from Ameya Karve.