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.
According to IMS data, the US market for this product is approximately USD 25 Million with three generic players. The product will be launched immediately.
Amantadine Hydrochloride Capsules are indicated for the treatment of Parkinson’s disease and in the treatment of Shingles (Herpes Zoster) to reduce pain.
The Bengaluru-based Strides Shasun has global manufacturing foot print with 8 production facilities spread across three continents including 6 US FDA approved facilities and 2 facilities for the emerging markets. The Company has three dedicated R&D facilities in India with global filing capabilities and a strong commercial footprint across 85 countries.