Aurobindo Pharma slipped 3.23% to Rs 851.70 after the U.S. Food and Drug Administration released details of the warning letter issued to the company's New Jersey unit in October 2020.
On 22 October 2020, the drug maker informed that its wholly-owned stepdown subsidiary, AuroLife Pharma, had received a warning letter from United States Food & Drug Administration (USFDA) for its oral solid manufacturing facility situated at Dayton, New Jersey.The warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. "Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B), the US drug regulator said in a statement.
Further, the USFDA said: Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant.
Aurobindo had said that the exclusive sales from this facility is around 2% of the group turnover and had further assured that the company would work closely with the regulator to comprehensively address the issues.
Aurobindo Pharma is engaged in producing oral and injectable generic formulations and active pharmaceutical ingredients (APIs).
The drug maker's consolidated net profit rose 26% to Rs 805.65 crore on 15.77% rise in revenue from operations to Rs 6,483.44 crore in Q2 September 2020 over Q2 September 2019.
Powered by Capital Market - Live News
(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)
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
RECOMMENDED FOR YOU