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Fulvestrant API

Cas Number : 129453-61-8
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About Fulvestrant API

Fulvestrant API was developed at Minakem’s Louvain-la-Neuve facility more than 15 years ago for the originator, Astra Zeneca. Fulvestrant API CAS number is 129453-61-8.

Minakem has developed in 2024 a second generation of process, more environmentally friendly and more competitive at the same time.

From a regulatory perspective, Minakem offers:

  • A European DMF (CEP) – 2024
  • A Japanese DMF – expected in 2025

Minakem’s Fulvestrant API brings:

  • A competitive process to reduce your FDF costs
  • A High-quality production standards.

Fulvestrant is clasiified as a high potent API, which requires specific equipment to handle it in a safely manner.

Therapeutical Class and Mechanism of Action

Fulvestrant API  is a drug used to treat breast cancer, as an  hormonal therapy, for cancer that has spread to other parts of the body (secondary breast cancer). The main therapeutical objective of metastatic breast cancer treatment is to delay disease progression.

 Fulvestrant is an oestrogen receptor antagonist, which binds, blocks and degrades the oestrogen receptor,

 Fulvestrant original form was approved under the trade name Faslodex in 72 countries in 2011.

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, 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

Fulvestrant API’s data are available on

Pharmaoffer

Fulvestrant API additional data are available on

Wikipedia

Get in touch Fulvestrant API

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