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Aurobindo Pharma gets 8 USFDA observations for 2 facilities in Hyderabad


Aurobindo Pharma gets 8 USFDA observations for 2 facilities in Hyderabad

The USFDA inspected active pharmaceutical ingredients (API) manufacturing facility (Unit V) at Pashamylaram and API manufacturing facility (Unit VIII) at Gaddapotharam in Hyderabad between October 21 and October 28, Aurobindo Pharma said in a filing.

New Delhi: Aurobindo Pharma on Wednesday said the US health regulator has issued four observations each for its two units in Hyderabad after inspecting the sites last month.

The USFDA inspected active pharmaceutical ingredients (API) manufacturing facility (Unit V) at Pashamylaram and API manufacturing facility (Unit VIII) at Gaddapotharam in Hyderabad between October 21 and October 28, the company said in a BSE filing.

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“At the end of the inspections, we have been issued a Form 483 with four observations for each facility. We believe that these observations are related to procedural improvements and none of the observations is related to data integrity,” it added.

The company will be responding to the USFDA as per the prescribed timelines, the drug firm said. The inspection of the formulation manufacturing facility (Unit IV) at Pashamylaram is underway, it added.

Read Also: Aurobindo Pharma Unit-7 documents inaccurate, misleading: USFDA


Source: PTI
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