sorafenib Tablets 200 mg
Dossier type
US CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP, US
Manufacturer #15017
A pharmaceutical manufacturer based in the EU that has been active for 20+ years.
The main therapeutic areas include oncology.
The company's production lines are GMP-compliant.
Manufacturer usually replies in 5 days
Sorafenib
Sorafenib is a kinase inhibitor used in the treatment of primary kidney cancer called advanced
renal cell carcinoma, advanced primary liver cancer called hepatocellular carcinoma, FLT3-
ITD positive AML and radioactive iodine resistant advanced thyroid cancer. The survival
rates amongst patients who are administered were 60% in the 1st year, 35% in the 2nd year,
and 26% in the third year. A wide-ranging study conducted in Asia pacific also proved the
efficacy of this treatment.
Sorafenib is primarily marketed as Nexavar. But given its use around the world, it is
manufactured and sold by suppliers and labellers around the world.
Bayer and Onyx Pharmaceuticals developed and marketed Sorafenib. Sorafenib was
approved by the U.S. Food and Drug Administration in 2005 and received European
Commission’s marketing authorization in 2006.
Forms and Dosage
Sorafenib is sold as a tablet of 200 mg strength. The dosage in the treatment of Renal Cell Carcinoma as Indicated is 400 mg every 12 hours or twice a day. In the treatment of Hepatocellular Carcinoma, the recommended dosage is 400 mg administered every 12 hours and in the treatment of thyroid cancer the recommended initial dosage is 400 mg, however, in the cases of toxicity, the doctor will monitor and change the dosage as needed. The median treatment during using this medication is a little over 5 months.The wholesale cost of Sorafenib
Sorafenib is an expensive medication. In the USA, the consumers have to pay for, Nexvar
oral tablet 200 mg, around $20,870 for a supply of 120 tablets. In Europe, a year’s treatment
costs $57,232 in the UK but much lower, at $49,715 in Spain, and lower still, $44,543 in
France. Given the high cost and it life-saving nature, many countries in the develop world
subsidize or refund the cost of this treatment.
In India, Bayer sold a month's supply, 120 tablets for US$3,900. However, the Indian Patent
Office granted Natco Pharma a license to manufacture generic Sorafenib 2012, this resulting
in the price coming down by 97%.
How does Sorafenib work?
Sorafenib is a kinase inhibitor .Sorafenib blocks tumor cell growth in many ways. Its actions
in the body stop the signals that tell cancer cells to grow while also preventing cancer cells
from forming new blood vessels, thus stopping their growth. Sorafenib does only target
enzymes on the surface of cancer cells but also within the cell. Many of these targets are
involved in the making of blood vessels. After getting the desired information using targeted
therapy, it is used to create a targeted therapy to attack the cancer cells without damaging the
normal cells.
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