From USFDA
Strides Shasun has received approval from USFDA for Amantadine Hydrochloride Tablets 100 mg. The product received approval in 15 months under the new GDUFA regime. The product will be launched immediately.The Company also recently received USFDA approval for Amantadine Hydrochloride Capsules and the combined market size of Tablets and Capsules is approximately USD 47 million.
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