Lupin Receives EIR From USFDA For API Facility In Vizag
Global pharma major Lupin on Monday said that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its API manufacturing facility located in Visakhapatnam (Vizag), India.
The EIR was issued post the last inspection of the facility conducted from March 6 to March 10, 2023. The inspection closed with the facility receiving an inspection classification of "No Action Indicated" (NAI).
“We are happy to have received the EIR for our Vizag facility from the US FDA," said Nilesh Gupta, Managing Director, Lupin. “We remain committed to ensuring the high quality of our products and ensuring the safety of our manufacturing processes,” Gupta added.
The company on Monday also said that it is set to launch Thiamine Hydrochloride Injection USP, Multiple-dose Vials, after Lupin’s alliance partner Caplin Steriles Limited (Caplin) received approval for its ANDA from the USFDA.
Thiamine Hydrochloride Injection Multiple-dose Vials is therapeutically equivalent to the reference listed drug (RLD), Thiamine Hydrochloride Injection of Fresenius Kabi USA LLC. Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S. (IQVIA MAT April 2023).
