Products

API

Our API portfolio** consists of the following:
Therapeutic Category Name of API Regulatory Status
USDMF EDMF COS
Anti-cancer Afatinib Dimaleate *
  Anastrozole (USP)
Bicalutamide (USP/EP)
Busulfan (USP/EP) *
Belinostat *
Bendamustine Hydrochloride *
Carfilzomib *
Carboplatin (USP/EP) *;
Decitabine *
Docetaxel trihydrate (EP)
Docetaxel Anhydrous (USP/EP)
Gemcitabine Hydrochloride (USP/EP)  
Gemcitabine Alternate Process (EP)
Irinotecan Hydrochloride Trihydrate (USP/EP) *
Ibrutinib *
Letrozole (USP/EP)
Oxaliplatin (USP/EP)
Paclitaxel Semisynthetic (USP/EP)
Pemetrexed Diacid
Anaesthetics Bupivacaine Hydrochloride (USP) $
  Levobupivacaine Hydrochloride
Ropivacaine Hydrochloride Monohydrate (USP/EP) *
Drug Intermediate 10-DAB      
Granted USDMF: United States drug master file
EDMF: European drug master file
COS: Certificate of suitability
* Filed
$ Closed
PIPELINE PRODUCTS
Azacitidine Cabazitaxel Cladribine
Erlotinib Fludarabine Imatinib

**Fresenius Kabi shall not be responsible for patent infringement, if any, of products mentioned above. It shall be buyer’s responsibility to check and verify patent status in concerned country before placing orders. Products currently on patent are available for such R&D use as permitted under 35 USC 271 (e) (1).

 

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