Strides Shasun has received approval from the United States Food & Drug Administration (USFDA) for Amantadine Hydrochloride Capsules USP, 100 mg. The product received approval in 15 months under the new GDUFA regime.
The US market for this product is around $25 million with three generic players, as per IMS data. The product will be launched immediately.
Strides Shasun (formerly known as Strides Arcolab) is engaged in manufacturing, sale and export of pharmaceutical products. It offers general tablets, hard gelatin and soft gelatin capsules, sachets, potent drugs and semi-solids.
