Drug maker Lupin on Monday said it has received an establishment inspection report (EIR) from the US health regulator for its inhalation research centre in Florida.
The facility was inspected by the US Food and Drug Administration (USFDA), between February 19, 2020, and February 26, 2020, on behalf of the UK Medicines and Healthcare Products Regulatory Agency (UKMHRA) for company's application for generic Fostair.
"The receipt of the EIR with satisfactory ‘voluntary action indicated' status validates our commitment towards ensuring the highest levels of quality and current good manufacturing practice compliance at all our sites," Lupin Ltd CEO Vinita Gupta said in a statement.
The Inhalation Research Center at Coral Springs, Florida, inaugurated in August 2015, focuses on research and development of respiratory products for the treatment of asthma, chronic obstructive pulmonary diseases and other respiratory ailments.
"We are grateful for the USFDA's confidence in our team during this critical juncture in the fight against COVID-19, when it has become imperative that we focus on bringing high quality respiratory products to market," Gupta said.
USFDA issues an EIR to the company when an inspection is satisfactorily closed.
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