FDA Restricts Imports from Viatris’ India Facility Amid Compliance Concerns

The U.S. Food and Drug Administration (FDA) has imposed restrictions on the import of 11 products manufactured at Viatris’ drug production facility in Indore, India. This decision, announced by Viatris at the beginning of the week, follows the FDA’s identification of violations of federal requirements at the plant. The import alert has raised questions about the impact on supply chains and the company’s ability to meet regulatory standards.
The FDA issued a warning letter to Viatris after conducting an inspection at the facility in Madhya Pradesh. While the specifics of the violations were not disclosed, the agency stated that the affected products would not be allowed into the U.S. until the issues outlined in the warning letter were resolved. The facility primarily produces oral finished doses, such as tablets and capsules, which are critical components of Viatris’ global product portfolio.

In response to the FDA’s actions, Viatris has implemented a comprehensive remediation plan aimed at addressing the compliance issues. This includes corrective and preventive measures designed to rectify the deficiencies identified during the inspection. The company has also enlisted independent third-party experts to provide additional guidance and ensure the remediation process aligns with regulatory expectations. Viatris has assured that it will submit a detailed response to the FDA within the required timelines.
The company noted that discussions with the agency might result in conditional exceptions for other products, beyond the four already permitted to prevent shortages in the U.S. market. However, details about the specific products affected by the import restrictions remain unclear.
Viatris’ operations in India are extensive, with four manufacturing sites producing a range of medications, including antibacterials, diabetes treatments, and cardiovascular therapies. These facilities play a vital role in the company’s global supply chain, supporting a diverse therapeutic portfolio.

Viatris’ origins trace back to the 2020 merger of Mylan and Pfizer’s off-patent drug business. While its production capabilities in India are significant, the company is currently playing tug of war with stringent regulatory standards across international markets. Neither Viatris nor the FDA has responded to requests for comment, leaving some uncertainty about the timeline for resolving the compliance issues.