Alembic Pharma rises on tentative USFDA nod for ophthalmic solution

Alembic Pharmaceuticals gained 0.32% to Rs 620 after the company said it has received US drug regulator's tentative approval for Alcaftadine Ophthalmic Solution, 0.25%.

Alembic Pharmaceuticals on 20 April 2020 announced it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Alcaftadine Ophthalmic Solution, 0.25%.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Lastacaft Ophthalmic Solution, 0.25%, of Allergan, Inc. (Allergan).

Alcaftadine Ophthalmic Solution is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.

Alcaftadine Ophthalmic Solution, 0.25% has an estimated market size of $7 million for twelve months ending December 2019 according to IQVIA.

Alembic has a cumulative total of 120 ANDA approvals (107 final approvals and 13 tentative approvals) from USFDA.

On a consolidated basis, the pharmaceutical company's net profit rose 37.9% to Rs 234.19 crore on a 18.76% increase in the net sales to Rs 1,209.13 crore in Q3 December 2019 over Q3 December 2018.

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

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