East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Oxycodone Hydrochloride Oral Solution USP, 5 mg/5 mL (1 mg/mL) and 100 mg/5 mL (20 mg/mL). Aurobindo’s Oxycodone Hydrochloride Oral Solution USP, 5 mg/5 mL (1 mg/mL) and 100 mg/5 mL (20 […]
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Methotrexate Tablets USP, 2.5 mg. Aurobindo’s Methotrexate Tablets USP, 2.5 mg are an AB-rated generic equivalent to the reference listed drug (RLD), Rheumatrex Tablets, 2.5 mg, of DAVA Pharmaceuticals, Inc. Methotrexate Tablets
Aurobindo Receives FDA Approval for Methotrexate Tablets USP, 2.5 mg. Read More »
Aurobindo Pharma USA, Inc. Contact – 1-866-850-2876 option 2 Recall returns being handled by: Qualanex: Contact 1-888-504-2014 FOR IMMEDIATE RELEASE – December 30, 2019 – East Windsor, NJ, Aurobindo Pharma USA, Inc. is voluntarily recalling lot number 03119002A3 of Mirtazapine Tablets to the consumer level. The product is being recalled due to a label error
Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 38 Lots of Ranitidine Tablets 150mg, Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL due to the detection of NDMA (Nitrosodimethylamine) Impurity Aurobindo Pharma USA, Inc. contact {1-866-850-2876 option 2} Recall being handled by: Qualanex: Contact 1-888-504-2014 FOR IMMEDIATE RELEASE November 6,
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Carbidopa Tablets, 25 mg. Aurobindo’s Carbidopa Tablets, 25 mg are an AB-rated generic equivalent to the reference listed drug, Bausch Health Americas, Inc.’s Lodosyn® Tablets, 25mg. Carbidopa Tablets are indicated for use
Aurobindo Receives FDA Approval for Carbidopa Tablets, 25 mg Read More »
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for Cinacalcet Hydrochloride Tablets, 30mg, 60mg, and 90mg. Aurobindo’s Cinacalcet Hydrochloride Tablets are an AB-rated generic equivalent to the reference listed drug, Amgen Inc’s Sensipar. Cinacalcet Hydrochloride tablets are indicated for the
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for Fenofibric Acid Delayed-Release Capsules, 45 mg and 135 mg. Aurobindo’s Fenofibric Acid Delayed-Release Capsules is an AB-rated generic equivalent to the reference listed drug, Abbvie Inc.’s TRILIPIX®. Fenofibric Acid Delayed-Release Capsules
AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 39 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity. AurobindoPharma USA, Inc. contact 1-866-850-2876 Option 2 Recall being handled by: Inmar\CLS-Medturn contact 1-877-208-2407 Acetris returns partner contact 888-280-2043 FOR IMMEDIATE RELEASE: 03/01/19: AurobindoPharma USA,
Acquisition for an upfront purchase price of $160 million in cash plus up to $140 million on achieving regulatory and sales-based milestones Acquired portfolio includes seven branded oncology injectable products which are currently being marketed. The acquisition also brings-in an experienced branded commercial infrastructure in the US The portfolio is expected to generate a revenue
East Windsor, N.J. – Aurobindo Pharma Limited has launched Atazanavir Capsules 100 mg, 150 mg, 200 mg, and 300 mg upon receiving final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application. Aurobindo’s Atazanavir Capsules are an AB-rated generic equivalent to the reference listed drug REYATAZ®. Atazanavir capsules is indicated
Aurobindo Launched Atazanavir Capsules Read More »
Aurobindo became a partner to Dispensary of Hope in 2012. In only 5 short years, Aurobindo has donated 3,736,413 doses of medicine. Almost 30% of these doses were donated in 2017. This is largely due to the quick and additional response to Hurricane Harvey relief efforts with additional donations. Pharmaceutical products are provided to the
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Aurobindo has participated in Spectrum360’s annual “Fore the Kids” Golf Tournament for the past 5 years. Both as a participant and as a sponsor, Aurobindo has contributed over $20K to this organization to enable greater access and participation to children of diverse abilities. Mission Statement: “Spectrum360’s mission is to provide the highest quality educational and