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Alembic Pharma share price up 2% on USFDA final approval

The company has a cumulative total of 111 ANDA approvals (99 final approvals and 12 tentative approvals) from USFDA.

January 15, 2020 / 11:13 IST
 
 
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Alembic Pharmaceuticals share price added over 2 percent intraday on January 15 after the company received USFDA final approval for Tizanidine Hydrochloride capsules.

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, as per company release.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Zanaflex Capsules of Covis Pharma B.V. Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity.

Tizanidine Hydrochloride Capsules mg have an estimated market size of USD 28 million for 12 months ending September 2019, according to IQVIA.

The company has a cumulative total of 111 ANDA approvals (99 final approvals and 12 tentative approvals) from USFDA.

At 10:49 hrs Alembic Pharmaceuticals was quoting at Rs 572.65, up Rs 10.65, or 1.90 percent on the BSE.

Moneycontrol News
first published: Jan 15, 2020 11:13 am

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