USFDA concludes inspection at Aurobindo Pharma Telangana facility with zero observations

Medical Dialogues team had earlier reported that the USFDA had issued Form 483 with 2 observations at the end of the inspection at the Company's wholly owned subsidiary, APL Health Care Limited’s Unit I & III, an Orals (Tablets, Capsules and Soft gel Capsules) and Derma Manufacturing facility located at Jadcherla, Mahabub Nagar District, Telangana.

Read also: Aurobindo Pharma arm gets 2 USFDA observations for Unit I, III in Telangana

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 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, Brazil ANVISA. The Company’s product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.