Viatris Faces FDA Restriction on Drug Imports

Viatris announced on Monday that the US Food and Drug Administration (FDA) has imposed import restrictions on 11 products manufactured at its facility in India. This decision follows an inspection by the FDA which revealed violations of federal requirements.

The FDA has issued a warning letter to Viatris in relation to its drug manufacturing facility in Indore, Madhya Pradesh, India. The specifics of the warning have not been disclosed by the company. Viatris stated that the 11 products will not be accepted into the US until the warning letter is resolved.

Due to potential shortages, the FDA has granted conditional exceptions for four products. Viatris anticipates further discussions with the FDA could lead to additional exceptions. The facility in question produces oral finished doses, including tablets and capsules.

Viatris, formed through the merger of Mylan and Pfizer's off-patent drug business, operates four sites in India that manufacture a wide range of therapeutic categories such as antibacterials, diabetes drugs, and cardiovascular therapies.

Viatris is committed to addressing the FDA's concerns promptly. The company has implemented a remediation plan at the site and engaged independent third-party experts to support necessary corrective and preventive actions. Both Viatris and the FDA are yet to respond to additional requests for details from Reuters.