Vincristine sulfate API (lyophilized for injectable)

Vincristine sulfate API (lyophilized for injectable) was developed at Minakem’s Belgium facility in Louvain-la-Neuve more than 20 years ago.
Vincristine sulfate API CAS number is 2068-78-2

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

Therapeutical Class and Mechanism of Action
Vincristine API is an antineoplastic agent and belongs to the vinca alkaloids class of chemotherapy drugs. Vincristine API is commonly used in the treatment of various cancers, including leukemias, lymphomas, and solid tumors. Its effectiveness is often enhanced when used in combination with other chemotherapy drugs.
Vincristine works by inhibiting microtubule dynamics, which are essential for cell division. Its mechanism involves the following steps:
• Binding to Tubulin
• Inhibition of Microtubule Polymerization
• Cell Cycle Arrest
• 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 Vincristine API
Vincristine’s data are available on Pharmaoffer.

Vincristine additional data are available on Wikipedia