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Aurobindo Pharma Unit-7 gets 7 USFDA observations

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Aurobindo Pharma Unit-7 gets 7 USFDA observations

The United States Food and Drug Administration (USFDA) conducted a Current Good Manufacturing Practices (CGMP) inspection at the company’s unit-7 manufacturing facility from September 19 to 27, Aurobindo Pharma said in a filing to the BSE.

New Delhi: Drug firm Aurobindo Pharma on Monday said it has received seven observations from the US health regulator for its unit-7 in Telangana.

The United States Food and Drug Administration (USFDA) conducted a Current Good Manufacturing Practices (CGMP) inspection at the company’s unit-7 manufacturing facility from September 19 to 27, Aurobindo Pharma said in a filing to the BSE.

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Also Read: SEBI slaps fine of Rs 22 crore on Aurobindo Pharma, promoters for insider trading

The inspection ended with seven observations, it added.

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“We believe none of the observations are related to data integrity. The company is confident of addressing these issues within the stipulated timeline,” Aurobindo Pharma said.

The company, however, did not provide any details about the observations made by the US regulator.

Headquartered in Hyderabad, the company’s area of activity includes six major therapeutic/product areas; antibiotics, antiretrovirals, cardiovascular products, central nervous system products, gastroenterological, and anti-allergics

Also Read: Aurobindo Pharma recalls 2352 bottles of Simvastatin tablets over the labelling issue


Source: with inputs
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