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Alembic Pharmaceuticals Limited announced on Wednesday that 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 approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Zanaflex Capsules, 2 mg, 4 mg, and 6 mg, of Covis Pharma B.V. Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeut ic effect, treat ment wit h tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important.
Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg have an estimated market size of $28mn for twelve months ending September 2019 according to IQVIA.
Alembic has a cumulative total of 111 ANDA approvals (99 final approvals and 12 tentative approvals) from USFDA.
Alembic Pharmaceuticals Ltd is currently trading at Rs569.50 up by Rs7.5 or 1.33% from its previous closing of Rs562 on the BSE.
The scrip opened at Rs565 and has touched a high and low of Rs576.75 and Rs564.50 respectively. So far 46,115 (NSE+BSE) shares were traded on the counter. The current market cap of the company is Rs10,593.70cr.