Lupin gets Establishment Inspection Report from FDA for Aurangabad facility

Topics Lupin Pharma | USFDA | Pharma sector

Drug firm Lupin on Monday said it has received an Establishment Inspection Report (EIR) from the US health regulator for its Aurangabad facility in Maharashtra.

The facility was inspected by the US Food and Drug Administration (USFDA) between May 6-15, 2019, Lupin said in a BSE filing.

Lupin said its Aurangabad facility is involved in the manufacturing of oral solid dosage, oral liquid and powder for oral suspension products for the US Market, WHO/Global Institution markets and Indian market.

"Lupin is committed to adherence and full compliance with current good manufacturing practice (cGMP) regulations and all other applicable regulatory requirements at our manufacturing sites. We are very happy to receive the EIR for our Aurangabad facility marking the satisfactory closure of the USFDA inspection," Lupin Managing Director Nilesh Gupta said.

The USFDA issues an EIR to an establishment that is the subject of an FDA or FDA-contracted inspection when the agency decides to close the inspection.

Lupin's shares were trading 1.05 per cent lower at Rs 757.75 apiece on the BSE.

Dear Reader,

Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.

We, however, have a request.

As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.

Support quality journalism and subscribe to Business Standard.

Digital Editor

Business Standard is now on Telegram.
For insightful reports and views on business, markets, politics and other issues, subscribe to our official Telegram channel