Yet another Indian drugmaker has had plants written up by the FDA for not hitting manufacturing standards. This time it is Natco Pharma, which said it got Form 483s for its pharmaceutical formulations facility at Kothur, near Hyderabad, as well as an API plant at Manali, near Chennai, which it had to close in December because of flooding in the area.
The citations followed inspections in February and March, the drugmaker disclosed Sunday in a filing with the Bombay Stock Exchange (BSE), in which it downplayed the issues.
"The company has received 483 observations for both facilities and believes them to be of minor in nature," Natco said in its filing. "The company has already sent response and compliance report for these observations and believes that there would be no adverse impact to its current or future pipeline products coming from these facilities."
Perhaps, but the drugmaker gave no indication of what was troubling the FDA and how it was responding. Issues that other drugmakers have disclosed and believed didn't amount to much later turned into bigger deals for the FDA than first indicated. In 2014, for example, India's Cadila Healthcare also acknowledged that it had gotten a Form 483 for a manufacturing plant in Moraiya but said it didn't expect any impact on its business. Eighteen months later, the FDA issued warning letters to Cadila not only for the Moraiya formulations plant but also for its Zyfine API plant in Ahmedabad. The agency criticized the drugmaker for, among others things, slipshod heparin manufacturing, pointing out that the company even stopped production in 2014 over some of the problems.
In December, Natco had to close its API plant at Manali because of heavy flooding that pushed thousands of people from their homes, closed the airport and also forced other companies to close up manufacturing operations. At the time, Natco said in a BSE filing, "The company believes that this temporary shutdown should not impact/impair its pipeline launches associated with the plant."
- here's the BSE release