Aurobindo Pharma gets USFDA Approval for Azithromycin Oral Suspension
Deepthi | Myequity news | Date : 11-10-2018 11:35:00 IST
Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Azithromycin Oral Suspension 100 mg /5 mL and 200 mg/5 mL. Azithromycin oral suspension, a generic version of Pfizer Inc’s Zithromax® oral suspension. The product will be launched in November 2018. About Aurobindo Pharma Limited:
Azithromycin oral suspension is indicated for the treatment of patients with mild to moderate infections. The approved product has an estimated market size of US$ 71 million for the twelve months ending August 2018, according to IQVIA.
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 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, Anti-Allergies and Anti- Diabetics, supported by an outstanding R&D set-up. The Company is marketing these products globally, in over 150 countries.