India’s Aurobindo Pharma Receives FDA Approval for Hypertension Drug
Hyderabad based Aurobindo Pharma declared approval of its hypertension tablet composed of amlodipine and valsartan by the US Food and Drug Administration (FDA). The news was followed by rise in the shares of Aurobindo Pharma by 2% on Bombay Stock exchange.
The FDA approval is for the manufacture and marketing of amlodipine and valsartan tablets. The approved dosages are 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg. This drug is a therapeutic and bio equivalent of the reference listed drug (RLD) Exforge of Novartis Pharmaceuticals. The drug is expected to be launched in the first quarter of the financial year 2016-2017.
According to Aurobindo Pharma the drug has an estimated market size of $123 million in the 12 month period ending February 2017.
Amlodipine belongs to a class of drugs called as dihydropyridine type calcium blockers. It lowers blood pressure by widening blood vessels. It does so by inhibiting the influx of calcium into the vascular smooth muscle cells and cardiac muscle cells. The influx of calcium into cells is required for contractile process of cardiac muscle cells.
Figure 1. Mechanism of action of calcium channel blockers
Valsartan is an angiotensin II receptor antagonist. It works to reduce blood pressure by blocking the action of angiotensin II.
Figure 2. Molecular mechanism of angiotensin II receptor antagonist.
The Unit VII of the company’s formulation facility for oral non-antibiotic products marked the 71st approved ANDA (Abbreviated New Drug Application) which manufactured out of it. The company has a huge market and commercialize its products in over 125 countries. Its marketing partners include AstraZeneca and Pfizer.
Aurobindo pharma is a market leader in semi-synthetic penicillin. It generated a revenue of $1.8 billion.
Aurobindo Pharma is one of the leading pharmaceutical companies in India. It became a public company in 1992 and listed its shares in the Indian Stock market in 1995. The company is a leading manufacturer of generic pharmaceuticals and active pharmaceutical ingredients. The company’s leading areas of activity include six major therapeutic and product areas: antibiotics, antiretrovirals, cardiovascular products, central nervous system products, gastroenterological, anti-allergics.