Strides Shasun has received approval from the United States Food & Drug Administration (USFDA) for Amantadine Hydrochloride Tablets 100 mg. The product received approval in 15 months under the new GDUFA regime. According to IMS data, the US market for this product is approximately $22 million with two generic players. The product will be launched immediately.
Besides, the company has also recently announced USFDA approval for Amantadine Hydrochloride Capsules and the combined market size of Tablets and Capsules is approximately $47 million.
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.
