Aurobindo Pharma's Injectable Facility Receives Seven Observations from US FDA

1 Mar 2024 , 10:27 AM

Aurobindo Pharma received seven observations from the US FDA for its injectable facility in Telangana, as reported on February 29. The US FDA inspected the injectable facility of Eugia SEZ Pvt. Ltd., a 100% step-down subsidiary of Aurobindo Pharma Ltd., from February 19-29. Aurobindo Pharma stated that the observations are procedural and will be addressed within the specified timeframe.

Eugia Pharma Specialities Limited, another subsidiary, has resumed production in terminally sterilized product lines at Unit-III, following a temporary halt to address previous USFDA observations concluded on February 2, 2024. Production in the aseptic lines of the facility is expected to restart in March 2024.

Earlier, the USFDA issued nine observations for Eugia Unit III after inspecting the plant from January 22 to February 2, citing concerns like the lack of procedures to prevent microbiological contamination, incomplete lab records, and inadequate validation of aseptic processes.

Aurobindo Pharma Limited, headquartered in HITEC City, Hyderabad, India, is a multinational pharmaceutical company focusing on generic pharmaceuticals and active pharmaceutical ingredients.

The company operates in six major therapeutic and product areas, including antibiotics, anti-retrovirals, cardiovascular products, central nervous system products, gastroenterological, and anti-allergics. Aurobindo Pharma markets its products in over 125 countries, with key partners like AstraZeneca and Pfizer.

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