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INDIA'S TORRENT PHARMA FILES 4 ANDAs, 3 DMFs WITH USFDA.
MUMBAI, April 3 Asia Pulse - Torrent Pharmaceuticals Ltd (BSE:500420) on Friday said it has filed four Abbreviated New Drug Applications (ANDA) and three Drug Master Files (DMF) with the United States Food and Drug Administration (USFDA) as part of its launch plan for US markets.
Three ANDAs have been filed for metformin instant release, sertraline and zolpidem, while the fourth was filed for Citalopram in the third week of March, the company informed the Bombay Stock Exchange.
Three DMFs were filed for Sertraline, Venlaflaxin and Ropinorole in the API segment, while USFDA would be reviewing the API facilities, it said.
The DMF for Sertraline is in advanced stage of review, it added.
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