Methotrexate

Overview

Methotrexate is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL34259).

API suppliers (18)

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

• FERMION OYFinland2 active DMF GMP on record
• CF PHARMA LTD1 active DMF
• Sichuan Huiyu Pharmaceutical Co., Ltd.China1 active DMF GMP on record
• EXCELLA GMBH AND CO KGGermany1 active DMF
• Huzhou Zhanwang Pharmaceutical Co.,ltd.China1 active DMF
• SICHUAN ELIXIR PHARMACEUTICAL CO LTD1 active DMF
• RAVI BIOLIFE PRIVATE LTDIndia1 active DMF
• SHILPA PHARMA LIFESCIENCES LTDIndia1 active DMF
• MSN Laboratories Private LimitedIndia1 active DMF GMP on record
• LIANYUNGANG PHARMACEUTICAL FACTORY
• BENZOCHEM LIFESCIENCES PVT LTD
• SEACROSS PHARMA USA INCChina
• PFANSTIEHL LABORATORIES INC
• MONSANTO CO
• Pfizer LtdUnited Kingdom
• BEN VENUE LABORATORIES INC
• SUMIKA FINE CHEMICALS CO LTD
• Zhejiang Hisun Pharmaceutical Co., Ltd.China GMP on record

EU CEP holders (6)

Companies holding a valid EU Certificate of Suitability (CEP) for Methotrexate, from the EDQM certification database. A CEP holder is a documented EU-market source of the substance — not necessarily the manufacturer — and these are not yet profiled in our directory.

Patent & exclusivity (US)

Per the FDA Orange Book (50 approved US products), the latest listed US patent on Methotrexate expires 28 Oct 2035. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

(2S)-2-[[4-[(2,4-diaminopteridin-6-yl)methyl-methylamino]benzoyl]amino]pentanedioic acid

Canonical SMILES

CN(CC1=CN=C2C(=N1)C(=NC(=N2)N)N)C3=CC=C(C=C3)C(=O)N[C@@H](CCC(=O)O)C(=O)O

InChIKey

FBOZXECLQNJBKD-ZDUSSCGKSA-N