Indian generics manufacturer Lupin has suspended production of drugs bound for the U.S. from a troubled active pharmaceutical ingredient plant in India, according to an FDA warning letter.
In the notice, the regulator has asked Lupin to provide notification “before resuming operations” at the Tarapur, Maharashtra, site if the company intends to manufacture drugs for the U.S. market.
In a regulatory filing Sept. 29 with the Bombay Stock Exchange, Lupin acknowledged receiving a warning letter from the FDA but did not indicate that it had halted production.
“The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility,” Lupin wrote.
The FDA warning letter was dated Sept. 27 but was not posted on its website until Nov. 1.
Lupin received the warning letter on top of a Form 483 notice, which detailed violations observed during an inspection of the plant from March 22 to April 4.
A statement from the company provided little clarity on the status of production at the plant.
“As part of our correspondence with the FDA, we have shared that although we have discontinued production of certain APIs in the past, we continue production of multiple APIs in a compliant manner," a company spokesperson wrote. "Several critical APIs for the U.S. are manufactured at the Lupin Tarapur facility in multiple dedicated manufacturing blocks. Several of these APIs are essential medicines and sole-source APIs."
In the warning letter, the regulator chided Lupin for inadequate manufacturing processes and failure to establish proper cleaning protocols. The company also failed to set up in-process samples and controls, and its own investigations into the plant’s deficiencies were lacking, the FDA found.
This isn’t the plant’s first brush with the agency. In January 2020, the FDA branded the facility with Official Action Indicated status, meaning “objectionable conditions were found and regulatory action should be recommended,” as the regulator explains online.
Another Lupin plant also has recently drawn scrutiny from the FDA. After an inspection last month at Lupin’s facility in Pune, the agency identified 17 observations in a Form 483 letter, which has yet to be posted by the agency. The notice was revealed (PDF) by Lupin in another regulatory filing.
Editor's note: A statement from the company was added after publishing time.