FDA's thumbs up to PFI reverberates through outsourcing industry
The US FDA has approved in only 11 months a first DMF (drug master file) of this kind.....
It has said "yes" to the sale of metformin hydrochloride tablets.
Thye are manufactured by Grandules India, an Indian company using a pharmaceutical formulation intermediate (PFI), an alternative to sourcing active pharmaceutical ingredients.
"The PFI is based on a "ready to compress" mix of APIs and excipients that can be directly fed into a hopper for compression of tablets.
However, Granules claims that its PFI model results in enhanced productivity, avoidance of granulation bottlenecks, significant lowering of manufacturing costs and less need for regulatory compliance.
“We always wanted to improve on our outsourcing offerings and this has provided us with a strong opportunity to do so,” said Krishna Prasad, managing director of Granules India."
To view the full article click here
It has said "yes" to the sale of metformin hydrochloride tablets.
Thye are manufactured by Grandules India, an Indian company using a pharmaceutical formulation intermediate (PFI), an alternative to sourcing active pharmaceutical ingredients.
"The PFI is based on a "ready to compress" mix of APIs and excipients that can be directly fed into a hopper for compression of tablets.
However, Granules claims that its PFI model results in enhanced productivity, avoidance of granulation bottlenecks, significant lowering of manufacturing costs and less need for regulatory compliance.
“We always wanted to improve on our outsourcing offerings and this has provided us with a strong opportunity to do so,” said Krishna Prasad, managing director of Granules India."
To view the full article click here
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