JB Chemicals -; Pharma gets USFDA approval for Venlafaxine Hydrochloride extended-release tablets

1 Dec 2022 , 09:16 AM

J B Chemicals & Pharamaceuticals Ltd has received ANDA approval from the USFDA for Venlafaxine Extended Release Tablets 37.5mg, 75mg, 150mg and 225mg.

As per the filing, this product is based on OROS (Osmotic Controlled Release Oral Delivery System) technology, an advanced and precision-controlled release mechanism.

The generic product approval is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 75 mg, 150 mg, and 225 mg, of Osmotica Pharmaceutical U.S. LLC.

As per IQVIA Health MAT Oct 2022 data, Venlafaxine Extended-Release tablets recorded annualized sales of approximately $48 million in the US.

On Thursday early morning trade, J B Chemicals & Pharmaceuticals was trading at Rs2012.65 per share higher by 0.04% on the BSE.

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