Lupin gets EIR from USFDA for Oral Dosage facility in Aurangabad
Lupin Ltd'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.
Mumbai: Pharma major Lupin Limited (Lupin) recently announced the receipt of the Establishment Inspection Report (EIR) from the USFDA for its Aurangabad facility.
The facility was inspected by the US health regulator between May 6, 2019, and May 15, 2019.
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.
Commenting on the development, Nilesh Gupta, Managing Director, Lupin said, "Lupin is committed to adherence and full compliance with cGMP regulations and all other applicable regulatory requirements at our manufacturing sites. We are very happy to receive the EIR for our Aurangabad facility marking the satisfactory closure of the US FDA inspection."
Based in Mumbai, the company develops and delivers a wide range of branded and generic formulations, biosimilar products and APIs globally. It is a significant player in Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds the global leadership position in the Anti-TB segment.
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