Alembic Pharma gets USFDA approval for Fenofibrate tablets; stock trades flat

Alembic Pharma gets USFDA approval for Fenofibrate tablets; stock trades flat
Alembic Pharmaceuticals Limited (Alembic), a vertically integrated research and development pharmaceutical company, today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bimatoprost Ophthalmic Solution, 0.03%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Latisse Ophthalmic Solution, 0.03%, of Allergan, Inc. (Allergan). Bimatoprost Ophthalmic Solution, 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.

The stock is trading flat post this development.

Bimatoprost Ophthalmic Solution, 0.03% has an estimated market size of US$ 57 million for twelve months ending September 2019 according to IQVIA.

Alembic had previously received tentative approval for Bimatoprost Ophthalmic Solution, 0.03%. The launch of this product will be based on as per settlement agreement.

Alembic has a cumulative total of 113 ANDA approvals (101 final approvals and 12 tentative approvals) from USFDA.

Stock view:

Alembic Pharmaceuticals Ltd is currently trading at Rs588 down by Rs1.75 or 0.3% from its previous closing of Rs589.75 on the BSE.




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