Alembic Pharma share price gains on USFDA approval


Alembic Pharmaceuticals share price rose over a percent after the company received an approval from US Food & Drug Administration (US FDA).

The company has received approval from the US FDA for its abbreviated new drug application (ANDA) Midodrine Hydrochloride Tablets USP, 2.5 mg, 5 mg, and 10 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), ProAmatine Tablets, 2.5 mg, 5 mg, and 10 mg, of Takeda Pharmaceuticals USA, Inc. (Takeda).

Midodrine Hydrochloride Tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH).

Midodrine Hydrochloride Tablets have an estimated market size of USD 60 million for twelve months ending September 2020, according to IQVIA.

Alembic has a cumulative total of 138 ANDA approvals (120 final approvals and 18 tentative approvals) from USFDA.

At 11:14 hrs, Alembic Pharmaceuticals was quoting at Rs 956.05, up Rs 6.80, or 0.72 percent on the BSE.

News Source:- Moneycontrol

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