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Lupin receives FDA all-clear for Mandideep API manufacturing facility

Gareth Carpenter — 15 Apr 2020

Company becomes the fourth Indian pharma firm to secure FDA clearance in the last two weeks

Lupin has become the latest Indian pharmaceutical company to receive a clean bill of health from the US Food and Drug Administration for an active pharmaceutical ingredients (API) manufacturing facility.

On Wednesday, Lupin said it received an Establishment Inspection Report for its Mandideep Unit II plant from the US drug regulator with a Voluntary Action Indicated classification. The inspection at the facility was carried out between November 26, 2018 and December 4, 2018.

A VAI inspection classification indicates that the FDA will not take or recommend regulatory or enforcement action because any objectionable conditions found were not serious enough for it to do so.

“We are pleased to have received the EIR for our Mandideep Unit II facility, our important cardiovascular API manufacturing facility,” said Nilesh Gupta, Managing Director, Lupin. “We remain committed to enhancing compliance and quality standards across all our manufacturing sites.”

Earlier this week, Lupin received another EIR from the FDA for its largest and most-advanced oral solid dosage facility at Nagpur for an inspection carried out between January 6 and January 10, 2020.

Three other Indian companies have been given the FDA all-clear after API facility inspections over the last few days.

Dr. Reddy’s Laboratories received an EIR for its Plant-5 in Miryalaguda of Nalgonda District in Telangana, as did Strides Pharma for its Bengaluru plant. Meanwhile Biocon’s plant in Malaysia which manufactures insulin was also cleared by the FDA.

The robustness of international pharmaceutical supply chains has come into sharp focus recently – particularly from key API producers such as India and China -- as the COVID-19 pandemic continues to spread around the world.

Last week, India relaxed an export ban on anti-malarial drug hydroxychloroquine just 24 hours after US President Donald Trump warned of “retaliation” if the measure was not lifted. However, it is understood that Indian exports of the drug -- which has shown promise in treating patients with COVID-19, but is not currently approved as a therapy for the disease -- will only be made available to foreign governments and not private companies.

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