Calcium Folinate / Leucovorin Calcium

Active Pharmaceutical Ingredients (API)

Formula

CERBIOS - PHARMA SA
CAS number: 1492-18-8, 41927-89-3

 

Synonyms

Leucovorin Calcium
(6RS)-N5-Formyl-5,6,7,8-tetrahydrofolic acid
Calcium Leucovorin
Folinic Acid Calcium Salt

 

Background and use

Cerbios has been manufacturing the API Calcium Folinate, one of the most important reduced folates, for more than 20 years and is distributing and selling the product worldwide to a large number of customers. Calcium Folinate is mainly used in the treatment of colon and rectal cancer in combination with 5-fluorouracil (5-FU) and oxaliplatin (folfox regimen) or in combination with 5-FU and irinotecan (folfiri regimen). Additionally, it is used as rescue therapy to reduce toxic effects after high dose treatment with methotrexate in the treatment of some neoplastic diseases, rheumatoid arthritis and severe psoriasis. Last but not least, Calcium Folinate is also used in the treatment of anaemia caused by folate deficiencies. More information is given in the general Reduced Folates chapter

 

    • Active Pharmaceutical Ingredients (API)
    • Drug
      Substance
    • Patent
    • DMF
    • CEP
    • Calcium Folinate / Leucovorin Calcium

 

Regulatory compliance

Cerbios’ Calcium Folinate is complying to the specifications of the European and United States Pharmacopoeia. In 1997, a Certificate of Suitability of the European Pharmacopoeia was granted by the European Directorate for the Quality of Medicines (EDQM). The EDMF and the US-DMF are active and updated

Intellectual property

The method of production is patent protected in the following patents: EP 1 116 721; US 6 162 914; AU 744 296

Packaging information

The active ingredient is packed in double low density polyethylene bags in high density polyethylene containers. Variable quantities of API up to 20kg of material per container are offered.