Aurobindo Pharma USA facility gets 9 USFDA observations

The company believes that this OAI classification may not have any material impact on the existing revenues, the supplies of our US business, or pipeline products at this juncture, it said.

The exclusive sales from this facility are around 2 percent of the group turnover and the company will work closely with the regulator to comprehensively address the issues, it further said.

As per the USFDA, a Form483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

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Aurobindo Pharma Limited is a pharmaceutical manufacturing company headquartered in Hyderabad, India. The company manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company's area of activity includes six major therapeutic/product areas: antibiotics, anti-retrovirals, cardiovascular products, central nervous system products, gastroenterological, and anti-allergics.

The company markets these products in over 150 countries.

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