USFDA inspection: Aurobindo Pharma arm Telangana facility gets 2 observations
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-12-18 07:00 GMT | Update On 2024-12-18 07:00 GMT
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.
Read also: Aurobindo Pharma arm gets positive opinion from EMA Committee for Zefylti for neutropenia treatment
"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.
Read also: Aurobindo Pharma arm bags USFDA nod for cancer drug Pazopanib
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.