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