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Developing and filing for both small-molecule and biological cancer therapies forms a key part of Aurobindo’s strategy to target higher-value products. Aidan Fry examines the company’s plan in this Generic’s bulletin Dec 2017 article.

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300mg and 400mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Quetiapine Fumarate Extended-Release Tablets 50 mg, 150 mg, 200 mg, 300 mg, and 400 […]

Frankfurt, 24 October 2017 – Aurobindo Pharma Limited and Generics Bulletin are pleased to announce that Aurobindo has won the Company of the Year, Asia-Pacific Award at the Global Generics & Biosimilars Awards 2017, organized by Generics Bulletin. The Company of the Year, Asia-Pacific Award was sponsored by Eva Pharma and judged by an expert panel. “Congratulations […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Prasugrel Tablets, 5 mg and 10 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Prasugrel Tablets, 5 mg and 10 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Effient® […]

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 […]