Pharma manufacturer Lupin said its Aurangabad factory has successfully obtained an Establishment Inspection Report (EIR) from the US FDA for its May inspection.
The receipt of an EIR signifies the successful closing of the inspection as far as the company is concerned.
Lupin’s Aurangabad facility is involved in the manufacture of Oral Solid Dosage, Oral Liquid and Powder for Oral Suspension products for the US Market, WHO/Global Institution markets and the India market.
Nilesh Gupta, Managing Director, Lupin said the company is committed to “adherence and full compliance with cGMP regulations and all other applicable regulatory requirements”.
The company manufactures branded and generic formulations, biosimilar products and APIs globally. and is significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.
Lupin is the 8th largest generics pharmaceutical company by revenues and 3rd largest pharmaceutical player in the US by prescriptions. It is also the 3rd largest Indian pharmaceutical company by global revenues and the 5th largest company in the Indian Pharmaceutical Market.
