Global pharma major Lupin Limited on Monday announced 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.
According to the press statement, 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. We remain committed to ensuring the high quality of our products and ensuring the safety of our manufacturing processes,” said Nilesh Gupta, Managing Director, Lupin in a statment.
On Monday, the pharma major also launched the Thiamine Hydrochloride Injection USP, 200 mg/2 mL (100 mg/mL) Multiple-dose Vials, after Lupin’s alliance partner Caplin Steriles Limited (Caplin) received approval for its ANDA from the USFDA.
