Gemcitabine

CAS 95058-81-4 21 FDA-DMF suppliersSmall Molecule

Overview

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

API suppliers (26)

Suppliers of Gemcitabine backed by a verifiable FDA Type II Drug Master File. Source: FDA quarterly DMF list.

  • SHILPA PHARMA LIFESCIENCES LTD2 active DMF
  • ARCH PHARMALABS LTD2 active DMF
  • Intas Pharmaceuticals Ltd.India2 active DMF
  • Emcure Pharmaceuticals LimitedIndia2 active DMF
  • Laurus Labs LimitedIndia1 active DMF
  • Sun Pharmaceutical Industries LimitedIndia1 active DMF
  • SCINOPHARM TAIWAN LTD1 active DMF
  • Jiangsu Hansoh Pharmaceutical Group Company LimitedChina1 active DMF
  • Dr. Reddy's Laboratories Ltd.India1 active DMF
  • Jiangsu Hansoh Pharmaceutical Group Company LimitedChina1 active DMF
  • Dr. Reddy's Laboratories Ltd.India1 active DMF
  • SCINOPHARM TAIWAN LTD1 active DMF
  • Sun Pharmaceutical Industries LimitedIndia1 active DMF
  • Laurus Labs LimitedIndia1 active DMF
  • Hetero Labs LimitedIndia1 active DMF
  • Jiangsu Hansoh Pharmaceutical Group Company LimitedChina1 active DMF
  • Dr. Reddy's Laboratories Ltd.India1 active DMF
  • SCINOPHARM TAIWAN LTD1 active DMF
  • Sun Pharmaceutical Industries LimitedIndia1 active DMF
  • Hetero Labs LimitedIndia1 active DMF
  • Laurus Labs LimitedIndia1 active DMF
  • BENZOCHEM LIFESCIENCES PVT LTD
  • Zhejiang Hisun Pharmaceutical Co., Ltd.China
  • Cipla USA, Inc.USA
  • Cadila Healthcare LimitedIndia

Showing 25 of 26 suppliers — see the full list in the app.

Patent & exclusivity (US)

Per the FDA Orange Book (41 approved US products), the latest listed US patent on Gemcitabine expires 18 Aug 2034 and exclusivity 8 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

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