US FDA clears Lupin to supply US with meds made in Goa

By Gareth Macdonald contact

- Last updated on GMT

Related tags: Pharmaceutical drug, Food and drug administration

Lupin facility in Goa, US FDA green light (source Lupin)
Lupin facility in Goa, US FDA green light (source Lupin)
The US FDA has cleared Lupin to restart production of drugs for the US market at its plant in Goa after the Indian firm fixed problems observed by agency inspectors.

Lupin told investors it had received an establishment inspection report (EIR) this month​.

The firm said the notification means all issues observed by Food and Drug Administration (FDA) inspectors who visited the facility in March have been resolved.

At the time​ of the March inspection Lupin said the problems identified by the US related to “inadequacy and adherence to SOPs​” but did not provide additional information.

In a statement announcing the EIR, CEO Vinita Gupta said: “We are committed to ensuring that all systems and processes followed by Lupin are compliant with cGMP and are committed to bringing quality products to market.

Gupta added that: “We are grateful for the US FDA’s confidence in our corrective action plan and in our team.”

Second FDA OK

The Goa facility manufactures oral solid dose and injectable pharmaceutical products. The EIR is the second Lupin has been issued by the FDA for the facility this year.

In July​, it told investors that issues identified during an FDA inspection in July 2015 had been successfully addressed.

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