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January 26, 2018


Aurobindo Receives FDA Approval for Tenofovir Disoproxil Fumarate Tablets

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Tenofovir Disoproxil Fumarate Tablets, 150 mg, 200 mg, 250 mg, and 300 mg. Aurobindo’s Tenofovir Disoproxil Fumarate Tablets are an AB-rated generic equivalent to the reference listed drug VIREAD®. Tenofovir […]

January 03, 2018


Aurobindo Receives FDA Approval for Lorazepam Tablets USP

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Lorazepam Tablets USP, 0.5 mg, 1 mg, and 2 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Lorazepam Tablets USP to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Ativan®. Lorazepam […]

January 03, 2018


Aurobindo Receives FDA Approval for Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP, 5 mg/160 mg/12.5 mg, 5 mg/160 mg/25 mg, 10 mg/160 mg/12.5 mg, 10 mg/160 mg/25 mg, and 10 mg/320 mg/25 mg. Aurobindo’s Amlodipine, Valsartan […]

January 02, 2018


Aurobindo Pharma USA receives the Community Enhancement Award from East Windsor Township!

It is an East Windsor Township tradition to recognize businesses – how important they are to the community, how proud the township is of them and how they contribute to the community – every year, Mayor Janice Mironov said There are three awards – the Business Beautification Award, the Community Service Award and the Community […]

December 15, 2017


Aurobindo aims at cancer as it climbs the value chain

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.

December 01, 2017


Aurobindo Receives FDA Approval for Quetiapine Fumarate Extended Release Tablets.

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 […]

October 30, 2017


Aurobindo wins Company of the Year, Asia-Pacific Award at the Global Generics & Biosimilars Awards 2017

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 […]

October 30, 2017


Aurobindo Receives FDA Approval for Prasugrel Tablets, 5 mg and 10mg

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® […]

October 11, 2017


Aurobindo Receives FDA Approval for Ezetimibe Tablets USP, 10 mg

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 […]

October 11, 2017


Aurobindo Receives FDA Approval for Moxifloxacin Ophthalmic Soln. 0.5%.

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 […]

August 08, 2017


Aurobindo Receives FDA Approval for the line of OC tablets Aurovela™

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 […]