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Granules, Amneal Pharma get FDA nod

Our Regional Bureau  |  Chennai/ Hyderabad 

India Limited and of the United States have received the approval for their tablets of 500 mg, 850 mg and 1000 mg.
This is the first time that the USFDA has approved an ANDA with a PFI (pharmaceutical formulation intermediate)-drug master file ( DMF) as a raw material, the claimed in a press release here on Tuesday.
The PFI concept of India involves preparing a 'ready-to-compress' mix of active pharmaceutical ingredients and excipients which can then be directly fed into a hopper for compression of tablets.
"This development has helped us being recognised as more than an over-the-counter player and has opened up a new vista of business opportunities for India," the company's managing director, Krishna Prasad, stated.

First Published: Wed, August 02 2006. 00:00 IST