Replies to post #1816 on Fresenius Kabi Pharmaceuticals (APCVZ)

[Funstick]

I don't mean to be mean but does anyone really know what is going on??

I know I don't!

[roelien]

I agree. It appears that the manufacturing is by Frensenius Kabi Oncology for

Paclitaxel
Epirubicin
Irinotecan
Mitoxantrone
and now also Bicalitamide and Letrazole for the US markets (APP).
Not sure whether just the API (i.e Pactitacel,etc) is manufactured by Frensenius Kabi Oncology and then imported by APP as a intermediate to be used in the final BOM of the final injectable oncology product, ie. Paclitaxel Injection, USP or whether the injectable sterile manufacturing occurs at the Frensenius Kabi Oncology Manufacturing Plant in India and is then imported as a semi-finish product and APP does the final packaging and labeling for Sales and distribution in the US market. I think it is the 1st scenario since APP had to also go through the approval process for the final product of every different dose of the injectables.

Links:

APP products
http://www.appdrugs.com/ProductDetail.html?pfid=202&name=Paclitaxel_Injection_USP

Frensuis Kabi Oncology approced Products for the US:

http://www.fresenius-kabi-oncology.com/products_Canada.html

I will have take another look at the FDA approval for Bicalitamide to see how the relationship will be there.