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Aurobindo Pharma subsidiary gets 10 observations from USFDA for API plant

The observations are procedural in nature and will be responded to within the stipulated time, the drug maker stated

Aurobindo Pharma, Aurobindo Pharma logo

Shares of Aurobindo Pharma on Monday ended 3.16 per cent down at Rs 1,462 apiece on BSE. | Photo: Company website

Press Trust of India New Delhi

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Aurobindo Pharma on Monday said the US health regulator has issued 10 observations after inspecting the API facility of its subsidiary in Telangana.

The US Food and Drug Administration (USFDA) inspected Unit-II, an active pharmaceutical ingredients (API) manufacturing facility of Apitoria Pharma, a wholly-owned subsidiary of the company, in Sangareddy district from September 23-27, 2024, the Hyderabad-based drug maker said in a regulatory filing.

The inspection closed with 10 observations, it added.

The observations are procedural in nature and will be responded to within the stipulated time, the drug maker stated.

Shares of Aurobindo Pharma on Monday ended 3.16 per cent down at Rs 1,462 apiece on BSE.

 

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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First Published: Sep 30 2024 | 5:30 PM IST

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