Lupin received a warning letter from USFDA for its Tarapur, Maharashtra (India) facility. The Lupin Tarapur facility was examined by the USFDA from March 22, 2022, to April 4, 2022.

The company believes that the warning letter will not affect supply disruptions or current revenues from this facility's operations.

 “We are dedicated to resolving the FDA's concerns and will collaborate with the FDA to fix these issues as soon as possible. We prioritise quality and compliance concerns and are dedicated to meeting CGMP quality requirements across all of our operations,” said Lupin in its regulatory filing.