USFDA nod to Aurobindo Pharma for Cephalexin Tablets
Hyderabad: Aurobindo Pharma Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Cephalexin Tablets USP, 250 mg and 500 mg.
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Keflet Tablets, 250 mg and 500 mg, of Eli Lilly and Company.
Aurobindo Pharma was granted Competitive Generic Therapy (CGT) designation for Cephalexin Tablets USP, 250 mg and 500 mg, and is eligible for 180 days of shared generic drug exclusivity.
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.
Read also: Aurobindo Pharma to acquire balance 49 percent stake in GLS Pharma for Rs 22.5 crores
