Aurobindo Pharma arm Telangana facility gets 9 USFDA observations
Hyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (USFDA) has concluded the inspection with 9 observations at Unit-III, a Formulation manufacturing facility, of Eugia Pharma Specialities Ltd., a wholly-owned subsidiary of the Company, situated at Pashamylaram, Patancheru Mandal, Sangareddy District, Telangana.
USFDA inspected the facility from 22nd January to 2nd February 2024. The inspection closed with 9 observations.
"We will be responding to these observations within the stipulated time. The company has decided to temporarily stop manufacturing on certain lines to conduct holistic investigation and corresponding partial distribution thereto," Aurobindo said in a BSE filing.
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"The company has already started working with the regulatory authority / third party consultants to accelerate the process and re-start production on those lines at the earliest. At this point in time, we don’t foresee any material impact on the business. The company remains committed to work closely with the US FDA and continues to enhance its compliance on an ongoing basis," Aurobindo further added.
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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 speciality pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 25 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 seven major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.
