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.
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