Alembic Pharma gets USFDA final nod for Doxycycline Hyclate tablets

Alembic Pharmaceuticals on Thursday said it received US drug regulator's final approval for Doxycycline Hyclate tablets USP, 20 mg.

The approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to the reference listed drug product (RLD) Periostat tablets, 20 mg of Galderma Laboratories, L.P. (Galderma). The drug has an estimated market size of $7 million for twelve months ending December 2019 according to IQVIA.

Doxycycline Hyclate tablets are indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.

Alembic has a cumulative total of 119 ANDA approvals (107 final approvals and 12 tentative approvals) from USFDA.

Shares of Alembic Pharma was down 1.18% to Rs 642.55, extending losses for second day. The stock has lost 2.53% in the past two trading sessions.

On a consolidated basis, Alembic Pharma's net profit rose 37.9% to Rs 234.19 crore on a 18.8% rise in the net sales to Rs 1209.13 crore in Q3 December 2019 over Q3 December 2018.

Alembic Pharmaceuticals is engaged developing formulations and active pharmaceutical ingredients (API).

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