Aurobindo Pharmaceutical Receives two USFDA Approvals
Aurobindo Pharmaceutical (APL) is Hyderabad based company engaged into manufacturing of 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. It has robust product portfolio spread over 6 major product areas encompassing Antibiotics, Anti Retrovirals, Cardio Vascular (CVS), Central Nervous System (CNS), Gastroenterological and Anti-Allergics supported by an outstanding Research and Development setup. APL is marketing these products globally in 125 countries across the globe.
APL got US FDA approval to manufacture and market Entacapone Tablets USP, 200mg. The company will launch this product in coming days. Entacapone Tablets are used in the treatment of Parkinson's disease. This disease is a chronic and progressive movement disorder. Parkinson's involves the malfunction and death of vital nerve cells in the brain. The approval is 39th Abbreviated New Drug Application (ANDA) from Unit VII formulation facility in Hyderabad for manufacturing of oral non beta lactum products. According to Intercontinental Marketing Services (IMS) the market size of the product was USD 59 million for year ending April 2015.
APL also gets US FDA approval to manufacture and market Azithromycin for Injection USP, 500 mg/vial. Azithromycin for injection, USP is a macrolide antibacterial drug indicated for the treatment of patients such as Community Acquired Pneumonia and Pelvic Inflammatory Disease. This will be marketed by the company's subsidiary AuroMedics Pharmaceutical LLC. APL has 12 ANDAs approved from Unit IV formulation facility in Hyderabad for manufacturing general injectable products.
Orion Corporation already has a reference listed drug product as Comtan tablets 200 mg. This is equivalent to approved Entacapone Tablets USP, 200mg. Azithromycin injection is also equivalent to reference listed drug product (RLD) Zithromax 500mg/vial of Pfizer. These are the competitor drugs for APL.
Once APL will start manufacturing Entacapone tablets and Azithromycin injection, it will help company to grow its revenue in current financial year. The company's consolidated total income for FY15 was Rs 12121 crore higher 49.64 per cent on yearly basis. Its net profit rose by 34.35 per cent to Rs 1576 crore in FY15 compared to previous fiscal. APL filed 78 ANDAs in FY14 and became largest number of pending ANDAs around 181 in US. The company has 45 product filings pending to USFDA in injectable segment and expecting around 25 approvals in current financial year. APL share surges by 0.8 per cent on BSE today with CMP of 1369.80 because of two US FDA approvals.