US FDA Goes After Another Indian Site with Form 483 for Strides Injectable Facility

05-Aug-2013 - Last updated on 16-Aug-2019 at 14:48 GMT

Strides Arcolab received a US FDA Form 483 for an injectables facility that provides for about 25% of subsidiary Agila’s revenues, which is currently in the process of being acquired by Mylan.

Although management did not go into detail on what observations were included in the Form 483, the warnings for the facility in Bangalore, India, comes at an inopportune moment for the Indian company since Mylan is looking to close its purchase of Agila, Strides’ injectables unit, for $1.6B.

Despite the warnings, Arun Kumar, vice chair and managing director of Strides, seems optimistic the 483 will not have a significant impact on the Mylan-Agila deal.

“First of all we are confident that the 483 issues will be addressed and secondly we don’t believe that adverse events will lead to the derailment in the transactions,” Kumar said in a recent conference call.

The company has already responded to the observations in the Form 483, he noted, though the agency may take up to five months to reveal “whether they are satisfied with our response or not.” Strides received Form 483s in eight out of 15 inspections from the FDA, Kumar added, though “we have addressed all these observations at all times to the satisfaction of the agencies and that is how we continue to maintain a compliance record.”

He also said the company is awaiting the approvals from the FIBP (Foreign Investment Promotion Board) and US FTC (Federal Trade Commission) before the sale of Agila to Mylan is complete.

India Crackdown

The announcement comes at a time when the FDA is looking to crack down on Indian manufacturers suspected of wrongdoing.

Last month, Fresenius Kabi’s API plant in Kalyani, India, received a Form 483 after the company announced the recall of an injection contaminated with glass particles.

Another Indian firm Wockhardt saw its products banned from importation to the US in May by the FDA. The company also received a warning letter from the FDA last month.

But these examples may not set the bar for Strides, which is continuing to expand its biotech and R&D business. Kumar noted in the call that Strides’ new R&D center in Bangalore is being built, while the ground breaking for the company’s biotech facility in Malaysia is scheduled for Q4 2013.