JB Pharma gets US FDA nod for depression treatment drug

J.B.Chemicals & Pharmaceuticals (JB Pharma) said that it has received ANDA approval from the USFDA for Venlafaxine Hydrochloride extended-release tablets of various strengths.

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 of Osmotica Pharmaceutical U.S. LLC.

Venlafaxine oral tablet is used to treat depression (immediate-release tablet and extended-release tablet). It's also used to treat social anxiety disorder (extended-release tablet only). Venlafaxine may be used as part of a combination therapy.

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

J.B. Pharma is one of the fastest growing pharmaceutical companies in India and a leading player in the hypertension segment. Besides its strong India presence, which accounts for majority of its revenue, its other two home markets are Russia and South Africa. The company exports its finished formulations to over 40 countries including the USA. Besides supplying branded generic formulations to several countries, it is also a leader in the manufacturing of medicated lozenges.

For the second quarter ended 30 September 2022, the company recorded revenue of Rs 809 crore as compared to Rs 593 crore in the same period last year, registering growth of 36%. Profit after tax stood at Rs 111 crore as compared to Rs 98 crore, registering growth of 13%.

The scrip was up 0.01%, to currently trade at Rs 2017.35 on the BSE.

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