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Aurobindo Pharma arm gets 2 USFDA observations for Unit I, III in Telangana
Hyderabad: Aurobindo Pharma has announced that the US Food and Drug Administration (USFDA) has 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.An FDA...
Hyderabad: Aurobindo Pharma has announced that the US Food and Drug Administration (USFDA) has 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.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The inspection was held from January 9 to January 18, 2023.
The observations are procedural in nature.
Read also: Aurobindo Pharma arm gets USFDA nod for Azacitidine for Injection to treat myelodysplastic syndrome
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 24 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.
Read also: Aurobindo Pharma JV Tergene gets CDSCO panel recommendation for 15-valent Pneumococcal Polysaccharide Conjugate Vaccine
Ruchika joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at firstname.lastname@example.org Contact no. 011-43720751