Aurobindo Pharma receives USFDA approval for Ertapenem Injection
Myequity news service | Date : 26-06-2018 11:30:00 IST
Aurobindo Pharma Limited has received final US Food & Drug Administration (USFDA) approval from the US Food & Drug Administration (USFDA) to manufacture and market Ertapenem Injection 1 g/vial.
Aurobindo’s Ertapenem injection is a generic equivalent of Merck Sharp and Dohme Corp’s Invanz Injection. Ertapenem injection is used for the treatment of moderate to severe infections caused by susceptible bacteria.
Aurobindo will launch this product in July 2018. According to IQVIA, the approved product has an estimated market size of USD 387 million for the 12 months period ending April 2018.
This ANDA is approved out of Auronext Pharma’s (wholly owned subsidiary) formulation facility in Bhiwadi, India used for manufacturing penem injectable products. Aurobindo now has a total of 371 ANDA approvals (338 Final approvals including 17 from Aurolife Pharma LLC and 33 tentative approvals) from USFDA.About Aurobindo Pharma Limited:
Aurobindo Pharma Limited, headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, Japan PMDA, WHO, Health Canada, MCC South Africa, ANVISA Brazil. The company’s robust product portfolio is spread over 7 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, Anti-Allergies and Anti-Diabetics, supported by an outstanding R&D set-up.
Aurobindo Pharma Limited closed 0.70% up at Rs 611.80