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East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Ezetimibe Tablets USP, 10 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Ezetimibe Tablets USP, 10 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug ZETIA®. Ezetimibe is indicated as […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Moxifloxacin Ophthalmic Soln. 0.5%. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Moxifloxacin Ophthalmic Soln. 0.5%. to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Vigamox® Moxifloxacin Ophthalmic Solution is indicated as […]

East Windsor, N.J. – The new Aurobindo Distribution Center is 567,000 square ft. facility which sits on 59 acres of land in East Windsor, New Jersey. This new facility will house Aurobindo solid dosage forms as well as AuroMedics injectables and OTC product from our Aurohealth division. The inventory will be stored within a state […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Aurovela™ line of OC tablets. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Aurovela™ to be bioequivalent and, therefore, therapeutically equivalent to Loestrin® line of oral contraceptive products. Please see table below for each of […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Sevelamer Carbonate Tablets, 800 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Sevelamer Carbonate Tablets, 800 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Renvela®. Sevelamer Carbonate is a […]

Hyderabad-based pharma major says US FDA approval likely to come after upcoming audit Hyderabad-based Aurobindo Pharma Limited is hoping to receive three-four product approvals in the oncology space from the US Food and Drug Administration (US FDA) before March 2018. The company’s optimistic prediction about a possible good start in this high-margin product business comes […]

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture Atomoxetine capsules, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg. Atomoxetine capsules are the AB rated generic equivalent of Eli Lilly and Company’s Strattera […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Glipizide Extended-Release Tablets, 2.5 mg, 5 mg and 10 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Glipizide Extended-Release Tablets, 2.5 mg, 5 mg and 10 mg to be bioequivalent and, therefore, therapeutically equivalent […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/20 mg, 5 […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg, and […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Olmesartan Medoxomil Tablets, 5 mg, 20 mg, and 40 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Olmesartan Medoxomil Tablets, 5 mg, 20 mg, and 40 mg to be bioequivalent and, therefore, therapeutically equivalent […]

Don’t Harm Patient Access to Affordable Generic Medicines by Chilling Generic Drug Competition. Governor Hogan Should Veto Legislation To Keep Generic Drugs Affordable For Maryland Statement by Chester “Chip” Davis, Jr., President and CEO of the Association for Accessible Medicines Read the full article