Gemcitabine

Overview

Gemcitabine is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL888).

API suppliers (21)

Suppliers of Gemcitabine evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.

• Intas Pharmaceuticals Ltd.India2 active DMF GMP on record
• SHILPA PHARMA LIFESCIENCES LTDIndia2 active DMF
• Emcure Pharmaceuticals LimitedIndia2 active DMF GMP on record
• ARCH PHARMALABS LTDIndia2 active DMF
• Laurus Labs LimitedIndia1 active DMF GMP on record
• DR REDDYS LABORATORIES LTD1 active DMF GMP on record
• SCINOPHARM TAIWAN LTDTaiwan1 active DMF
• Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
• Hetero Labs LimitedIndia1 active DMF GMP on record
• TAPI NL BVNetherlands1 active DMF
• YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDChina1 active DMF
• RAVI BIOLIFE PRIVATE LTDIndia1 active DMF
• FARMHISPANIA SASpain1 active DMF
• Jiangsu Hansoh Pharmaceutical Group Company LimitedChina1 active DMF GMP on record
• Gland Chemicals Private LimitedIndia1 active DMF
• MSN Laboratories Private LimitedIndia1 active DMF GMP on record
• MYLAN LABORATORIES LTD GMP on record
• Cadila Healthcare LimitedIndia
• BENZOCHEM LIFESCIENCES PVT LTD
• Zhejiang Hisun Pharmaceutical Co., Ltd.China GMP on record
• Cipla USA, Inc.USA

Patent & exclusivity (US)

Per the FDA Orange Book (41 approved US products), the latest listed US patent on Gemcitabine expires 7 Nov 2038 and exclusivity 9 Sept 2028. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

4-amino-1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one

Canonical SMILES

C1=CN(C(=O)N=C1N)[C@H]2C([C@@H]([C@H](O2)CO)O)(F)F

InChIKey

SDUQYLNIPVEERB-QPPQHZFASA-N