Company Overview of Aurobindo Pharma USA Inc.
Aurobindo Pharma USA Inc. manufactures generic pharmaceutical drugs. The company was incorporated in 2004 and is based in Dayton, New Jersey. Aurobindo Pharma USA Inc. operates as a subsidiary of Aurobindo Pharma Limited.
6, Wheeling Road
Dayton, NJ 08810
Founded in 2004
Key Executives for Aurobindo Pharma USA Inc.
Compensation as of Fiscal Year 2014.
Aurobindo Pharma USA Inc. Key Developments
Aurobindo Pharma USA, Inc. Issues Voluntary Nationwide Recall of Northstar Label Gabapentin Capsules
Nov 23 14
Aurobindo Pharma USA announced that it is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg 100-count bottles to the consumer level. The product lot has been found to contain some empty capsules. Empty capsules could result in missed dose(s) of gabapentin resulting in adverse health consequences that could range from no effect, short term reduction in efficacy, short term withdrawal effect, or status epilepticus (long period seizures) that could be life-threatening. The company has not received any reports of adverse events related to this recall to date, but has received four complaints for empty capsules. Gabapentin is used as in the treatment of epilepsy and for the management of postherpetic neuralgia (pain after shingles). The affected Gabapentin lot is GESB14011-A, Expiration 12/2015 and is packaged in 100-count bottles, NDC 16714-662-01. The product can be identified by the imprint D on yellow cap and 03 on yellow body with black edible ink. Product was distributed through Northstar label to retail outlets nationwide. The company is notifying its distributors and customers by recall letters and is arranging for return of all recalled product. Consumers, distributors, and retailers that have product which is being recalled should stop using, distributing, or dispensing the affected lot and return to place of purchase.
Bristol-Myers Drags Aurobindo and Aurobindo Pharma USA Inc. to US Court
Jun 10 14
Bristol-Myers Squibb has dragged Aurobindo and its Aurobindo Pharma USA Inc. to the US District Court of New Jersey for alleged patent infringement of its anti-HIV drug 'Reyataz'. In its plea, BMS said legal action has been initiated against Aurobindo for infringement of patent no. 6,087,383 and asked the local American court to with hold approval to manufacture and market a generic version of BMS's Reyataz before the expiration of its patent on December 21, 2018. Bristol-Myers Squibb legal action follows an Abbreviated New Drug Application (ANDA) No 204806 filed by Aurobindo Pharma Ltd. with the US Food and Drug Administration (USFDA) for approval to manufacture and market a generic version of BMS's Reyataz drug product. BMS had clocked sales of $394 million from Reyataz in its fourth quarter ended December 31, 2014. Seeking relief from the US court, BMS stated that damages or other monetary relief must be granted to the company if Aurobindo engages in the commercial manufacture, use, sale of its generic product prior to expiration of the '383 patent. BMS further added that it will be irreparably harmed if Aurobindo's infringement is not enjoined by the court.
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