Aurobindo Pharma tumbles after details of USFDA warning letter to unit

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 companys New Jersey unit in October 2020.

Nov 25, 2020 09:11 IST capital market

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 makers 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.

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