Aurobindo Pharma step-down arm AP facility gets product approval from USFDA

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-09-12 06:10 GMT   |   Update On 2024-09-12 06:10 GMT
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Telangana: Aurobindo Pharma has announced that the new injectable facility of Eugia Steriles Private Limited , a 100% subsidiary of Eugia Pharma Specialities Limited and a stepdown subsidiary of the Company, situated at Parawada Mandal, Anakapalli District, Andhra Pradesh, has received its first product approval from the US Food and Drug Administration (US FDA) for Lidocaine Hydrochloride Injection, USP, 1% (10 mg/mL) and 2% (20 mg/mL)

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The facility was inspected by the US FDA from March 28, 2024 to April 05, 2024.
The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility.

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 7 major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.

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