Levofolinate

In the clinical treatment of gastrointestinal tumors, megaloblastic anemia and other conditions, attenuation and synergism is one of the core considerations in regimen design. Levoleucovorin calcium is an anti-tumor adjuvant drug of folic acid analogs. Its mechanism of action is to provide a direct source of reduced folic acid to enhance the anti-tumor activity of fluorouracil drugs, and it can also be used to alleviate the toxic reaction caused by excessive methotrexate. Its clinically applicable population covers patients with gastrointestinal malignant tumors such as colorectal cancer and gastric cancer, as well as patients with megaloblastic anemia caused by folic acid deficiency, and it is an important variety in the fields of tumor chemotherapy supportive treatment and hematological disease treatment.

The overall domestic levoleucovorin calcium market presents a steady and rising development trend. The compound annual growth rate of the market in the past three years is about 4.2%, and the overall market size exceeded 1.2 billion yuan in 2023. In terms of competitive landscape, the current domestic preparation market is dominated by generic drugs, and more than 15 enterprises have obtained preparation production approvals. With the implementation of the volume-based procurement policy, product prices have gradually returned to a reasonable range, and the supply stability of APIs and impurity control capabilities have become the core considerations for downstream preparation enterprises when selecting suppliers.

The original research enterprise of levoleucovorin calcium is Teva Pharmaceuticals, with the original trade name Leucovorin Calcium. The core compound patent expired globally in 2016. At present, the main dosage form of the original research product on the market is injection, with common specifications including 50mg and 100mg per vial. It has been included in the FDA Reference Listed Drug Catalog, and also included in the domestic Catalog of Reference Preparations for Chemical Drugs. In terms of domestic API registration, more than 8 enterprises have completed the registration of levoleucovorin calcium APIs in CDE and obtained Class A status, and multiple varieties of supporting preparations have passed the consistency evaluation of generic drugs, with sufficient clinical accessibility. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for levoleucovorin calcium API. Most of the products are in stock. Spot orders paid before 16:00 can be shipped on the same day. All products meet the quality control requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the demand for impurity reference standards in the stages of API R&D, registration and declaration, and batch production.