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Last Updated : Dec 10, 2018 10:59 AM IST | Source: Moneycontrol.com

Alembic Pharmaceuticals gains on USFDA approval; NCD Committee meet on Dec 14

Olopatadine hydrochloride ophthalmic solution USP is indicated for the treatment of the signs and symptoms of allergic conjunctiviti's.

 
 
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Shares of Alembic Pharmaceuticals has turned positive after it received approval from the US Food & Drug Administration (USFDA).

The company shares declined 2 percent in the early trade on Monday.

The company has received approval from USFDA for its abbreviated new drug application (ANDA) Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1 %.

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The approved ANDA is therapeutically equivalent to the reference listed drug product RLD Patanol Ophthalmic Solution, 0.1 %, of Novartis Pharmaceuticals Corporation.

Olopatadine hydrochloride ophthalmic solution USP is indicated for the treatment of the signs and symptoms of allergic conjunctiviti's.

Alembic has a cumulative total of 83 ANDA approvals (70 final approvals and 13 tentative approvals) from USFDA.

This is first ophthalmic dosage form approval for Alembic pharmaceuticals.

A meeting of the NCD Committee of the company will be held on December 14 to consider and approve the issue and allotment of unsecured listed redeemable non-convertible debentures (NCDs) of upto Rs 350 crore on private placement basis.

At 10:45 hrs Alembic Pharmaceuticals was quoting at Rs 615, up Rs 0.60, or 0.10 percent on the BSE.

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First Published on Dec 10, 2018 10:57 am
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