Viatris Inc. (VTRS) Faces Investor Scrutiny After Possible Disclosure Delay About June 2024 FDA Inspection of Manufacturing Facility – Hagens Berman

/EIN News/ -- SAN FRANCISCO, March 13, 2025 (GLOBE NEWSWIRE) -- On February 27, 2025, investors saw the price of their shares of Viatris Inc. (NASDAQ: VTRS) tumble over 15% after the company disclosed an anticipated adverse 2025 monetary impact from the U.S. FDA’s recent December 2024 determination concerning the company’s oral dose manufacturing facility in Indore, India.

Hagens Berman is investigating possible misconduct concerning the timing of Viatris’ disclosures and urges investors who purchased Viatris shares and suffered substantial losses to submit your losses now. The firm also encourages persons with knowledge about the FDA’s inspection of Viatris’ Indore, India facility who may assist the firm’s investigation to contact its attorneys.

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844-916-0895

Viatris Inc. (VTRS) Investigation:

The investigation focuses on the propriety of Viatris’ disclosures to its investors about the FDA’s inspections of the company’s manufacturing facility in Indore, India.

On December 19, 2024, the FDA wrote a letter to Viatris’ CEO (Scott A. Smith) warning him and the company concerning the regulator’s inspection of Viatris’ drug manufacturing facility in Indore, India that the FDA inspected six months earlier from June 14 to June 26, 2024. The FDA advised “[b]ecause your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to [Current Good Manufacturing Practice], your drugs are adulterated[.]”

On December 23, 2024, Viatris revealed that the FDA issued an import alert related to its India facility and that “[f]ollowing the substance of FDA’s original inspection observations, we immediately implemented a comprehensive remediation plan at the site[]” and “[w]e have been in regular communication with FDA during this process and will continue to work to ensure that the Agency is satisfied with the steps we have taken to resolve all the points raised.”

Then, on February 27, 2025, Viatris disclosed to its investors that it expected a significant decline in 2025 revenues, primarily due to the Indore, India facility issues. The company quantified the adverse 2025 “negative impact from the Indore [India] facility of $500 million to total revenues and $385 million to adjusted EBITDA” This revelation drove the price of Viatris shares down about 15%, wiping out over $2 billion of shareholder value in a single day.

“We are investigating whether Viatris may have misled investors about its purported good manufacturing practices and anticipated costs for violations, if any,” said Reed Kathrein, the Hagens Berman Partner leading the firm's probe.

If you invested in Viatris and have substantial losses, or have knowledge that may assist the firm’s investigation, submit your losses now »

If you’d like more information and answers to frequently asked questions about the Viatris investigation, read more »

Whistleblowers: Persons with non-public information regarding Viatris should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email VTRS@hbsslaw.com.

About Hagens Berman
Hagens Berman is a global plaintiffs’ rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman’s team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw. 

Contact:
Reed Kathrein, 844-916-0895