Drugmaker Lupin’s Tarapur facility in Maharashtra has received a warning letter from the US Food and Drug Administration(USFDA). The USFDA inspected the Tarapur site this year from March 22 to April 4, the company told the Bombay Stock Exchange on Thursday. It however, added, that it did not believe, the warning letter would disrupt supplies or existing revenues from the operation of this facility. Lupin stocks closed almost 2.5 percent lower on the BSE, at ₹654.
The plant manufactures APIs (active pharmaceutical ingredients) for multiple products, through fermentation and chemical synthetic processes, a company spokesperson said, adding that manufacturing was not stopped at the plant while the remedial process was underway.
Updates announced
The company said it was committed to resolving the issue and was working with the US regulator to do so. The latest development comes even as the company announced updates on two other products in the US.
It has launched Sildenafil in the oral suspension form, the company said. This is a generic equivalent of Revatio from Viatris Specialty and this in turn is estimated to have an annual sales of $64 million in the US.
The company also received USFDA approval for its Abbreviated New Drug Application (ANDA), Mirabegron extended-release tablets ( 25 mg and 50 mg). The product is a generic equivalent of Myrbetriq (ER tablets) of Astellas Pharma Global Development Inc.
The product would be produced at Lupin’s facility in Nagpur, the company said. Mirabegron ER tablets ( 25 mg and 50 mg) is estimated to have an annual sales of $2403 million in the US.