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API

Our API portfolio** consists of the following:

Therapeutic Category	Name of API	Regulatory Status
Therapeutic Category	Name of API	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

**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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