Torrent Pharma gets USFDA approval

Mumbai, Nov 13 (UNI) Torrent Pharmaceuticals has received an approval from the United States Food&Drug Agency (USFDA) for its API and formulations manufacturing facilities (excluding the parenteral facility) located at Chhatral, about 40 kms from Ahmedabad.

Consequent to this, Torrent now expects approval of various ANDAs (Abbreviated New Drug Applications) and DMFs (Drug Master File) -- product dossiers for generic drug products&related APIs(active pharmaceutical ingredients) -- it has submitted to the Agency, the company said in a notice to BSE here today.

This will pave way for entry into the US market which is the biggest generic drugs market in the world.

Currently, the Company has submitted 3 DMFs and 5 ANDAs to the USFDA for approval. It has a development pipeline of 5 DMFs and 26 ANDAs.

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