Strides Arcolab recently joined a few of its fellow Indian drugmakers in a club no manufacturer wants to be part of. In June, the company became the latest in a series of Indian pharmas this year to draw critical observations from the FDA for production shortfalls. But unlike some of its counterparts, Strides will continue to send drugs to the U.S., as the company said Wednesday that everything is under control.
|Strides CEO Arun Kumar|
CEO Arun Kumar told Reuters that Strides had submitted its response to the FDA regarding the regulatory body's concerns at a Bangalore plant and was "confident about resolving it." As Business Standard reports, he cited a strong FDA track record, with 7 of 15 inspections coming up free of Form 483s--and the rest yielding observations that were addressed to the agency's satisfaction. "With our past experience, we are confident these Form 483s would be addressed in a diligent manner," Kumar told investors (as quoted by Business Standard).
Still, Strides' shares dipped as much as 17.1% on news of the Form 483, Reuters says. According to Business Standard, part of the worry was that the company's $1.6 billion sale of its specialty injectables unit to Mylan ($MYL), expected by September, might be delayed, as the FDA's observations dealt with a production line slated to be part of the deal. But Kumar said the Form 483 wouldn't impact the transaction.
It has not been an easy year for Indian drugmakers. In May, Ranbaxy Laboratories, India's top drugmaker by revenue, pleaded guilty to charges that it lied to cover up subpar manufacturing practices and paid $500 million to settle the case. That same month, Wockhardt wound up in the spotlight as the FDA landed it with an import ban for problems at its Waluj factory in western India. Last week, the agency released a warning letter it sent the drugmaker about a March visit, during which employees allegedly interfered with the inspectors and attempted to hide records. Jubilant Life Sciences also received a warning letter from the FDA in February, Reuters notes.