USFDA clears four Indian manufacturing plants in 10 days | Pharma News

MUMBAI: India’s leading drug companies have had their manufacturing facilities cleared in the last 10 days by the US Food and Drug Administration (USFDA), a decision that comes at a time when supply-chain disruptions due to the Covid-19 pandemic are causing drug shortages across the world.

On Monday, Lupin, the third largest generic drug supplier in the US by prescriptions, and Dr Reddy’s Laboratories received establishment inspection reports (EIRs), indicating closure of investigation by the US drug regulator of their manufacturing plants. Lupin’s manufacturing facility in the central Indian city of Nagpur was cleared based on a USFDA inspection conducted in January this year.

“We are very happy to have received the EIR for our Nagpur facility, our largest and most advanced oral solid dosage facility,” Lupin managing director Nilesh Gupta said.

Hyderabad-based Dr Reddy’s said the company got the EIR for its active pharmaceutical plant 5 at Miryalaguda in Telangana.

On the BSE, shares of Lupin jumped nearly 5% to close at ₹825.95 Monday, while those of Dr Reddy’s rose 3.5% to ₹3,744.50, even as the benchmark Sensex ended 1.5% lower.

Last week, Bengaluru-based Strides Pharma said the USFDA cleared its largest manufacturing facility, after an inspection in March. This plant in Bengaluru has capabilities to produce finished dosage formulations including tablets, capsules, ointments, creams and liquids, and complex generics. Biocon, another Bengaluru based company, got its insulin plant in Malaysia cleared by the USFDA.