Published Date : Jan 11, 2016
The United States Food and Drugs Association has officially given the nod of approval to Aurobindo Pharma to manufacture, sell, and market generic variants of norethindrone acetate within the U.S. market.
The U.S. health regulator has provided Aurobindo Pharma with the vital agreement to create 5 mg strength tablets of norethindrone acetate, as said by an Aurobindo Pharma spokesperson in a recent statement. They later added that the drug has an estimated market size of US$42 mn for the twelve months ending from November ’15, as denoted by the IMS.
The generic version produced by Aurobindo Pharma will be of the same strength of Aygestin tablets manufactured by Duramed Pharmaceuticals, as mentioned in another statement by Aurobindo Pharma.
Norethindrone acetate is vital for the treatment of uterine bleeding, also known as endometriosis, which is caused by the abnormalities in the levels of hormones in the human body.
Nearly 230 new abbreviated drug application approvals have been awarded to Aurobindo Pharma. Of these, 31 are tentative approvals, 10 are approvals from Aurolife Pharma LLC, and 199 other final approvals. However, Aurobindo Pharma shares were down 0.92%, to Rs. 838.40 per share in BSE’s afternoon trading sessions.
At the same time, the drug maker is also set to become the latest global conglomerate to establish its own Saudi Arabian factory. This is attributed to the investments made by the company in the King Abdullah Economic City’s sector of Industrial Valley. Aurobindo Pharma will be setting up its first manufacturing facility in Saudi Arabia, where the drug maker will produce oral capsules and tablets.
The deal is one of the major occurrences in the in the global pharmaceutical industry, which is experiencing major gains in momentum from the developing economies of China, India, and other nations of the Asia Pacific region. This is further exemplified by the 20 plus manufacturing facilities that are set up by Aurobindo Pharma through multiple partnerships in Brazil, the U.S., Europe, and India.