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Last Updated : Jan 15, 2020 11:13 AM IST | Source: Moneycontrol.com

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.

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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.

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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.

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First Published on Jan 15, 2020 11:13 am
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