Aurobindo Pharma Sangareddy facility gets 10 USFDA observations

Written by Ruchika Sharma Published On 2022-11-20T15:30:04+05:30 | Updated On 20 Nov 2022 3:30 PM IST

Aurobindo Pharma Sangareddy facility gets 10 USFDA observations

Hyderabad: Drugmaker Aurobindo Pharma has recently announced that the United States Food and Drug Administration (USFDA) has concluded an inspection with 10 observations at the Company's Unit - IX, an intermediate facility situated at Gundlamachnoor Village, Sangareddy District, Telangana.

The facility was inspected from November 10 to November 18, 2022.

The said Unit had been classified as OAI on May 17, 2019, and the Company had responded to the agency and carried out the required corrective actions.

Read also: Aurobindo Pharma US arm gets USFDA EIR for Raleigh facility

The US FDA Authorities have reinspected the facility as mentioned above. At the end of the inspection, the Company has been issued a 'Form 483' with 10 observations.

"In our view, these observations are procedural in nature and not related to data integrity. The Company will respond to the US FDA, within the stipulated timeline and shall work closely with the agency to address the observations at the earliest," the company stated in a recent BSE filing.

Aurobindo Pharma Limited is a 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, and Brazil ANVISA. The company's product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics, and Anti-Allergic.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751