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Aurobindo Pharma subsidiary's plant gets one observation from USFDA

Kajal RajputWritten by Kajal Rajput Published On 2022-08-30T12:23:03+05:30  |  Updated On 30 Aug 2022 12:33 PM IST
Aurobindo Pharma subsidiarys plant gets one observation from USFDA
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Hyderabad: Aurobindo Pharma on Monday said the US health regulator has issued one observation after inspecting a plant owned by its US-based unit. The US Food and Drug Administration (USFDA) conducted its Pre-Approval Inspection (PAl) and GMP (Good Manufacturing Practice) inspection from August 22-26 of Raleigh-based plant which has been set up for manufacturing MOl (Metered Dose Inhalers) and derma products, the Hyderabad-based drug firm said in a regulatory filing.

The plant is owned by Aurolife Pharma LLC, a wholly-owned step down subsidiary of the company, it added.

Also Read:Aurobindo Pharma net profit falls by 32 percent to Rs 520.5 crore in Q1

"At the end of the inspection, Aurolife has been issued a 'Form 483' with 1 observation and the observation is procedural in nature and there are no data integrity issues," Aurobindo Pharma said.

The company will respond to the USFDA within the stipulated timeline, it added.

As per USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 155 countries. The company has 27 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA.

The company's product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic.

Also Read:Aurobindo Pharma gets 3 USFDA observations for Andhra Pradesh facility

Aurobindo pharmaAurobindo pharma newsUSFDAUS Food and Drug AdministrationUSFDA InspectionAurolife Pharma LLC
Source : PTI
Kajal Rajput
Kajal Rajput

    Kajal joined Medical Dialogue in 2019 for the Latest Health News. She has done her graduation from the University of Delhi. She mainly covers news about the Latest Healthcare. She can be contacted at editorial@medicaldialogues.in.

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