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Last Updated : Mar 27, 2019 11:18 AM IST | Source: Moneycontrol.com

Alembic Pharma gains as co gets USFDA approval for Tadalafil tablets

Alembic now has a total of 89 ANDA approvals (77 final approvals and 12 tentative approvals) from USFDA.

 
 
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Shares of Alembic Pharmaceuticals rose 1.5 percent intraday on March 27 after the company received approval for Tadalafil tablets.

At 1055 hours, Alembic Pharmaceuticals was quoting at Rs 535.10, up Rs 5.55, or 1.05 percent.

The company in its press release said that it has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Tadalafil Tablets USP, 2.5 mg, 5 mg, 10-mg and 20 mg.

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The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Cialis Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg, of Eli Lilly and Company (Lilly).

All strengths of Tadalafil Tablets are indicated for the treatment of erectile dysfunction (ED). Tadalafil Tablet 5mg strength is additionally indicated for treatment of signs and symptoms of benign prostatic hyperplasia (BPH).

Alembic had previously received tentative approval for this ANDA.

Alembic now has a total of 89 ANDA approvals (77 final approvals and 12 tentative approvals) from USFDA.

At 1054 hours, Alembic Pharmaceuticals was quoting at Rs 535.10, up Rs 5.55, or 1.05 percent on the BSE.

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First Published on Mar 27, 2019 11:18 am
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