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Four Indian drug makers' manufacturing plants get USFDA clearance, says report

On April 13, Lupin received an Establishment Inspection Report from the FDA for its Nagpur plant.

April 14, 2020 / 04:18 PM IST
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The US Food and Drug Administration (USFDA) has recently cleared the manufacturing facilities of four Indian pharmaceutical companies, The Economic Times reported.

Lupin, Biocon, Strides Pharma Sciences and Dr Reddy’s Laboratories in March and April received the FDA's green signal for their plants.

The clearances come at a time when manufacturing and supply of drugs have been disrupted due to the coronavirus pandemic.

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According to Philippe Guerin, director of the Infectious Diseases Data Observatory at University of Oxford, dependence on India for generics will become an international challenge. India is the world's largest exporter of generic medicines.

“Governments and international organisations who depend on India for their supplies should look beyond their individual demands and support the Indian pharmaceutical supply chain. There is a need to look at contingency plans to assure access to APIs and medicines globally," Guerin told the paper.

On April 1, Biocon received an Establishment Inspection Report (EIR) from the FDA for its insulin manufacturing facility in Malaysia.

On April 13, Lupin received an EIR from the FDA for its Nagpur plant.

“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 told PTI.

Strides Pharma Science's flagship manufacturing facility in Bengaluru also passed an inspection on March 30.

Dr Reddy's Laboratories' Telangana plant cleared an FDA inspection on April 13.

"The inspection classification of this facility is determined as 'Voluntary Action Indicated' (VAI)," the company said in a statement.

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first published: Apr 14, 2020 04:16 pm