USFDA inspection: Aurobindo Pharma arm Telangana facility gets 2 observations
Telangana: Aurobindo Pharma has announced in a BSE filing that the US Food and Drug Administration (USFDA) has concluded inspection with 2 observations at Unit-V of Apitoria Pharma Private Limited, a wholly owned subsidiary of the Company, situated at Telangana.
The facility was inspected from December 09 to December 17, 2024.
"The United States Food and Drug Administration (US FDA) inspected Unit-V, an API manufacturing facility, of Apitoria Pharma Private Limited, a wholly owned subsidiary of the Company, situated at Pashamylaram Village, Patancheru Mandal, Sanga Reddy District, Telangana from December 09 to December 17, 2024," the Company stated in a BSE filing.
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"The observations are of procedural in nature and will be responded to within the stipulated time," it added.
Medical Dialogues team had earlier reported that Unit-II of Apitoria Pharma had also received ten observations from the USFDA.
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 150 countries.
The company has 29 manufacturing and packaging facilities that are approved by 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 seven major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic.
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