Drug firm Alkem Laboratories on Friday said the US health regulator has issued an establishment inspection report (EIR) for its manufacturing facility at Baddi in Himachal Pradesh.
The Baddi facility was inspected by the United States Food and Drug Administration (USFDA) from February 17 to 21, 2020, Alkem Laboratories said in a filing to BSE.
The USFDA has now issued an EIR for the manufacturing facility, it added.
On February 21, the company in a regulatory filing had said USFDA had issued a Form 483 with two observations at the end of the inspection of the facility.
It had said it shall put together a detailed response with adequate corrective and preventive measures to address the USFDA observations.
Shares of Alkem Laboratories were trading at Rs 2,468.40 per scrip on BSE, up 3.62 per cent from its previous close.
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.