Drug firm Alembic Pharmaceuticals on Wednesday said it has received final nod from the US health regulator for Tizanidine hydrochloride capsules, used to treat spasticity. "The company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg," the drug firm said in a regulatory filing. Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important. "The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Zanaflex Capsules, 2 mg, 4 mg, and 6 mg, of Covis Pharma BV," the filing said. Tizanidine hydrochloride capsules, 2 mg, 4 mg, and 6 mg have an estimated market size of USD 28 million for twelve months ending September 2019 according to IQVIA. Alembic has a cumulative total of 111 ANDA approval -- 99 final approvals and 12 tentative approvals -- from USFDA. The shares of Alembic Pharmaceuticals Ltd were trading at Rs 573, up 1.96 per cent on BSE in morning trade.
Sick and tired of always wondering if you are being asked to pay the right price for your APIs? This empowers you with the answers you need to make the right decisions in the Global API market.
Chemxpert Database is one of the biggest and most comprehensive directories of pharma and chemicals, manufacturers, suppliers and information. Provided with current information on prices, demand and transactions, it gives you instant feedback on whether you are buying what is right and at the right time.
Start using market intelligence today and allow yourself to be in control in the API market.
Check it out today and make more informed sourcing decisions! Learn More!