Aurobindo Subsidiary Gets USFDA Observations for API Plant

Sep 30, 2024 16:40

Aurobindo Pharma's subsidiary, Apitoria Pharma, received 10 observations from the USFDA after an inspection of its API facility in Telangana. The observations are procedural in nature and will be addressed.

New Delhi, Sep 30 (PTI) 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.

Source: PTI

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Aurobindo Subsidiary Gets USFDA Observations for API Plant

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