usfda: Lupine receives USFDA EIR for its manufacturing site in Goa, stock gain

The drugmaker said on Tuesday it received an Establishment Inspection Report (EIR) from the USFDA for its manufacturing facility in Goa, indicating that the company is likely on the verge of resolving the warning letter.

EIR stands for close of inspection.

Lupine said the USFDA has determined that the facility inspection classification is Indicated Voluntary Action (VAI), which means the USFDA will not recommend regulatory or enforcement action because unacceptable conditions do not meet. at the action threshold.

U.S. Drug Regulations inspected the facility in September 2021 and issued 7 observations, which were primarily related to out-of-specification drug production (OOS) investigations and raw material deficiency testing, among others.

The Goa oral solids manufacturing plant has been under USFDA scanner since 2017 for regulatory compliance issues. The facility has been a major contributor to Lupine’s exports.

“We are very pleased to have received the EIR from the US FDA with the voluntary action classification indicated for our plant in Goa. This is an important step as we strengthen our reputation for being best-in-class for quality and compliance, ”said Vinita Gupta, CEO of Lupine.

“The Goa site occupies a very prominent place in the US market with the number of affordable and quality drugs that we supply, and we now look forward to new products coming out of the site,” said Nilesh Gupta, Managing Director of Lupine.

Along with Goa (oral solids), Indore Unit-2 (makes solid oral and ophthalmic formulations), Mandideep Unit-1 (cephalosporins) and Somerset plants are under warning letters.

Lupine’s shares rose 6.44% and traded at Rs 941.05 on the BSE at 11:55 am, while the benchmark Sensex fell 0.39% to 58,054.68 points.