Torrent Pharmaceuticals Ltd on November 13, has announced that it has received an approval status 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, the Company now expects approval of various ANDAs & DMFs (product dossiers for generic drug products & related APIs) it has submitted to the Agency. This will pave way for entry into the US market which is 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.