Business Daily from THE HINDU group of publications
Wednesday, Aug 02, 2006


News
Features
Stocks
Cross Currency
Shipping
Archives
Google

Group Sites

Corporate - Regulatory Bodies & Rulings
Granules India gets USFDA nod for intermediates

Our Bureau

Hyderabad , Aug. 1

Granules India Ltd (GIL), and the US-based Amneal Pharmaceuticals LLC have announced that they have received approval for the abbreviated new drug application (ANDA) of anti-diabetic drug Metformin Hydrochloride tablets of 500 mg, 850 mg and 1,000 mg.

In a press release here, Granules said this is the first time that the United States Food and Drug Administration (USFDA) has approved an ANDA with PFI as raw material. While the USFDA approves drug master files (DMFs) for active pharmaceutical ingredients (APIs), this is the first time it has approved the DMF filed for PFI.

The PFI concept of Granules India involves preparing a `ready to compress' mix of APIs and excipients (inactive substances used in formulations), which can be directly fed into a hopper for compression of tablets. This concept relies on economies of scale and supply chain management of APIs and excipients.

"The fact that the USFDA approved this ANDA within 11 months of filing has shown the way for a greater reach for granulated products, thereby strongly reinforcing the business model of Granules India," its Managing Director, Mr Krishna Prasad told Business Line.

More Stories on : Regulatory Bodies & Rulings | Pharmaceuticals

Article E-Mail :: Comment :: Syndication :: Printer Friendly Page



Stories in this Section
Maruti hikes prices by Rs 500-5,000


Confusion over Infomedia record date for buyback
Visvesvaraya award entries
ICSI seminar on Aug 5
Herbertsons gets HC nod for merger
Visa Steel to commission Kalinganagar plant by Sept
Britannia plans to set up contract manufacturing units
Breathing equipment maker ResMed sets up office in India
Bangla power venture plan still on: Tata
Granules India gets USFDA nod for intermediates
DQ Entertainment buys 20% in French TV production house
Trivitron plans Rs 22-cr medical equipment unit
Discount issue: MRPL told to negotiate with OMCs
Tata Motors plans to expand retail network
Tariff panel recommendations could hit ONGC's revenues
Tata Motors June sales up 44.5%
Goa iron ore exports up 22 pc in first quarter
Jayshree Chem to hike caustic chlorine production
Addl charge for Rungta as SAIL chief


The Hindu Group: Home | About Us | Copyright | Archives | Contacts | Subscription
Group Sites: The Hindu | Business Line | Sportstar | Frontline | The Hindu eBooks | The Hindu Images | Home |

Copyright 2006, The Hindu Business Line. Republication or redissemination of the contents of this screen are expressly prohibited without the written consent of The Hindu Business Line