Viatris’ Indore plant under U.S. FDA scanner, imports of certain products barred 

The import alert affects 11 actively distributed products that will no longer be accepted into the U.S. until the warning letter is lifted. File. Representational image.
| Photo Credit: Reuters

Global pharma major Viatris has been issued a warning letter and an alert barring import of a clutch of products from its oral finished dose manufacturing plant in Indore, Madhya Pradesh, by the U.S. Food and Drug Administration (U.S. FDA).

The import alert affects 11 actively distributed products that will no longer be accepted into the U.S. until the warning letter is lifted. It makes exceptions, subject to certain conditions, for four products based on shortage concerns. There could be the potential for additional exceptions based on further discussions with the agency, Viatris said in a statement on December 23.

The warning letter and the import alert followed an U.S. FDA inspection of the oral finished dose manufacturing facility in Indore earlier this year, Viatris said.

Following the original inspection observations, the company “immediately implemented a comprehensive remediation plan at the site. The necessary corrective and preventive actions are well underway, including but not limited to related personnel actions. Additionally, we have engaged independent third-party subject matter experts to support the remediation plan,” it said.

“Our response to the warning letter and import alert will be submitted within the required time periods,” the company said.

In India, Viatris has four operational finished dosage form facilities — in Nashik, Aurangabad, Indore and Jadcherla (near Hyderabad) — that manufacture oral solid doses (OSD) like tablets and capsules, across a range of therapeutic categories such as antibacterials, antidiabetics, antiretrovirals, cardiovascular therapies and central nervous system agents. The company manufactures and supplies generic and branded generic OSD products from India to various markets including the U.S., Australia, Canada, Europe, Japan, New Zealand and Emerging Markets.