The Strides Pharma Global Pte Limited based in Singapore announced that, it has now received the approval for the Amantadine Hydrochloride Softgel Capsules USP of 100mg from the Food and Drug Administration (FDA) of the United States.
The products has been a bioequivalent and therapeutically equivalent to the RLD (reference listed drug) known as the Symmetrel Capsules of 100mg produced by the Endo Pharmaceuticals Inc.
According to the data from the IQVIA MAT December 2021, the market of the United States of the amantadine Hydrochloride Capsules USP 100mg has approximately around 11 million dollars, and this product is going to be manufactured at the facility of the company based in Bengaluru, India and it is also going to be marketed by the Strides Pharma Inc, in the United States market.
The company is also having the approval for the Amantadine Hydrochloride tablets and the combined market size if the capsules and tablets together has approximately been 21 million dollars as per the data.
