Vinblastine sulfate API (lyophilized for injectable)

Vinblastine sulfate API (lyophilized for injectable) was developed at Minakem’s Belgium facility in Louvain-la-Neuve more than 20 years ago.
Vinblastine sulfate API CAS number is 865-21-4

From a regulatory perspective, Minakem offers:
– An American DMF (Drug Master File)
– A European DMF (CEP)

Therapeutical Class and Mechanism of Action
Vinblastine sulfate API is an antineoplastic agent and belongs to the vinca alkaloids class of chemotherapy drugs. It is used in the treatment of various cancers, including Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, breast cancer, testicular cancer, and sarcomas.
Vinblastine works by inhibiting microtubule dynamics, which are essential for cell division. Its mechanism involves the following steps:
• Inhibition of Microtubule Formation that inhibits the ability of cancer cells to properly undergo mitosis (cell division).
• Mitosis Arrest, that leads to cell cycle arrest and eventual cell death;
• Induction of Cell Cycle Arrest, which ultimately causes cell death;
• Selective Toxicity to Cancer Cells.

About Minakem Louvain-la-Neuve’s Expertise
Minakem Louvain-la-Neuve has been manufacturing Active Pharmaceutical Ingredients (APIs) for over 20 years.
The site has a longstanding expertise in purification and the production of vinca derivatives (complex flower extracts derived from natural feedstock) and their transformation into APIs. Additionally, the site has experience in lyophilizing APIs for injectable applications, particularly in oncology treatments.
The site also manufactures controlled substances, including Remifentanil API.
Strategically located in the heart of Europe, near Brussels, the site exports 100% of its production globally.

About Minakem’s Network
Minakem Louvain-la-Neuve collaborates daily with Minakem’s other European facilities and Minakem Montreal, leveraging their complementary expertises in solid engineering, analytics, global regulatory affairs, and other capabilities to enhance competitiveness.
Minakem brings over 40 years of experience in developing, scaling up, registering Drug Master Files (DMFs), and manufacturing complex Active Pharmaceutical Ingredients (APIs), including chiral small molecules, steroids, and highly potent APIs (HPAPIs)—primarily used in oncology treatments.
As supply chain performance becomes increasingly critical to customers’ success, Minakem focuses on delivering:
• Safe products for patients,
• High On-Time-In-Full (OTIF) performance,
• Robust quality support, and
• Innovative solutions to address customers’ unexpected market demands.

More data on Vinblastine API
Vinblastine’s data are available on Pharmaoffer.

Vinblastine additional data are available on Wikipedia

  • Category
  • CAS NO.

    143-67-9

  • Regulatory Documentation

    CEP
    USDMF

  • Certificates

    GMP
    Nitrosamines
    TSE/BSE
    Non GMO
    Hallal

  • Structure

    Vinblastine sulfate API (lyophilized for injectable)

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