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Aurobindo Pharma receives USFDA’s final approval for Piperacillin and Tazobactam for Injection

Aurobindo Pharma Ltd. | Pharmaceuticals & Drugs | Healthcare | BSE: 524804 | NSE: AUROPHARMA

24 May 2011 Evaluate

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Piperacillin and Tazobactam for Injection 2.25g, 3.375g and 4.5g, packaged in single use vials. Aurobindo Piperacillin and Tazobactam is the third generic product approved in the US. With this, Aurobindo now has a total of 136 ANDA approvals (105 Final approvals and 31 Tentative approvals) from USFDA.

Piperacillin and Tazobactam for Injection 2.25g, 3.375g and 4.5g are the generic equivalent of Wyeth’s Zosyn Injection 2.25g, 3.375g and 4.5g Piperacillin and Tazobactam for Injection consists of semi-synthetic penicillin and a beta-lactamase inhibitor.

Piperacillin and Tazobactam Injection are indicated for the treatment of moderate to severe systemic and/or local bacterial infections in which betalactamase producing bacteria are suspected or have been detected, such as nosocomial pneumonia, complicated urinary tract infections (including pyelonephritis), intra-abdominal infections, skin and soft tissue infections, bacterial infections in neutropenic adults and bacterial infections in neutropenic children aged 2-12 years. These have a market size of approximately $635 million for the twelve months ending September 2010 according to IMS and will be launched soon.

Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, ANVISA Brazil. The company’s robust product portfolio is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergics, supported by an outstanding R&D set-up.

Aurobindo Pharma Share Price

1399.00 7.85 (0.56%)

22-Apr-2026 10:45 View Price Chart

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Aurobindo Pharma receives USFDA’s final approval for Piperacillin and Tazobactam for Injection

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