Taj Pharmaceuticals of India has received tentative approval from the US FDA to manufacture and sell Drug Papaverine capsules 150 mg to market in European Market.
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Papaverine, an opium alkaloid is used to treat visceral spasm, vasospasm, and erectile dysfunction, besides being used as a smooth muscle relaxant in microsurgery.
The FDA held Papaverine in its priority review for new molecular entity (NME) for more than 3 years.
Taj Pharmaceuticals makes pharmaceutical formulations and API for India and other countries.
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