NEW DELHI (Diya TV) — The U.S. FDA imposes import restrictions on the firm’s products produced from a facility in India at least 11 items. Viatris released information stating that on its company website on Dec.23 that the FDA was found to have restricted several items from an India-manufactured facility operated for them by the Indore Company. The facility did violate some of the regulation conditions under the Federal acts.
Responding to the findings by the FDA, the agency issued a warning letter to Viatris concerning the Indore facility. According to the FDA, the affected products will be banned from reaching the U.S. markets until the company addresses all the compliance issues highlighted by the letter. Although the names of the 11 products under restriction have not been made public, Viatris confirmed that the facility produces oral finished doses, including tablets and capsules, for a wide range of therapeutic applications.
Despite the import restrictions, the FDA has approved conditional exceptions for four products as there might be shortages of these drugs. These drugs will be permitted to import into the United States on a case-by-case basis, and the FDA said that there might be additional exceptions later following further talks with Viatris.
Viatris is a 2020 merger of Mylan and Pfizer’s off-patent drug division, and it has four manufacturing facilities in India. These are the Indore plant, among others. These plants manufacture a large variety of drugs, such as antibacterials, diabetes medications, and cardiovascular drugs, for global markets.
In a statement, Viatris said it is fully committed to the resolution of the issues identified by the FDA and assured that it has already initiated corrective action. “We have implemented a comprehensive remediation plan and are working with independent third-party experts to correct the issues identified by the FDA,” the company said. Viatris further confirmed that it would answer the warning letter and import alert within the time limits required by the FDA.
The company assured its customers and stakeholders that it is committed to maintaining a reliable supply of its products. “We take these matters seriously and are working diligently to ensure that we meet all regulatory requirements,” Viatris said.
These come at a time when supply chains for necessary medications continue to be stressed globally. Although the FDA has, in an attempt to diminish the effects of the import restrictions, authorized some items to continue being imported to the U.S., concern remains that sustained regulatory woes at the Indore plant may impact medicine availability in some cases.
Viatris’ Indore site plays a key role in the company’s global production network, supplying various generic medications to markets worldwide, including the U.S.
