Pharma major Lupin said its Nagpur plant has passed a Pre-Approval Inspection by the US Food and Drug Administration without incident.
The inspection, carried out in September, was related to the manufacture of Phenytoin Sodium Extended Release capsules to be sold in the US market.
Lupin’s Nagpur facility is the company’s latest site and manufactures Oral Solid Dosage products. The site also houses Lupin’s state of the art injectable manufacturing facility.
“The receipt of the Establishment Inspection Report for our Nagpur facility is a positive development as we continue our journey on meeting and exceeding global quality standards at all of our facilities,” said Lupin MD Nilesh Gupta.
Lupin, one of the world’s biggest makers of generic drugs, sells both branded & generic formulations, biotechnology products and pharmaceutical ingredients globally.
It focuses on cardiovascular, diabetology, asthma, pediatric, CNS, GI, anti-infective and NSAID segments of the pharma market.
It is the biggest manufacturer of anti-TB medicines.
As of September, the company was ranked 13th in terms of generics pharmaceutical companies globally in terms of market capitalization and 8th in terms of revenues.
It is also the third largest pharmaceutical player in the US by prescriptions and the fifth largest company in the Indian pharmaceutical market.