Alembic Pharma gains after USFDA nod for ANDAs

Alembic Pharmaceuticals rose 1.50% to Rs 570.45 after the company said it has received final nod from the US drug regulator for Tizanidine hydrochloride capsules, used to treat spasticity.

The company announced on Wednesday that it 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.

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 company said.

Tizanidine hydrochloride capsules, 2 mg, 4 mg, and 6 mg have an estimated market size of $28 million for twelve months ending September 2019 according to IQVIA.

In a separate announcement today, Alembic Pharma said it has received tentative approval from USFDA for its ANDA Empagliflozin tablets, 10 mg and 25 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Jardiance tablets, 10 mg and 25 mg, of Boehringer lngelheim Pharmaceuticals, Inc. (Boehringer).

Emapgliflozin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Emapgliflozin tablets have an estimated market size of $3.4 billion for twelve months ending September 2019 according to IQVIA.

Alembic has a cumulative total of 112 ANDA approvals (99 final approvals and 13 tentative approvals) from USFDA.

On a consolidated basis, the drug maker's net profit rose 23.1% to Rs 246.27 crore on a 10.1% rise in the net sales to Rs 1240.87 crore in Q2 September 2019 over Q2 September 2018.

The firm will declare its Q3 results on 22 January 2020.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company.

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