Minakem Review

About Minakem

Minakem: Your Trusted Partner for API Development and Manufacturing

Minakem is a leading Contract Development and Manufacturing Organization (CDMO) that specializes in the development and production of Active Pharmaceutical Ingredients (APIs) and Highly Potent APIs (HPAPIs). With over 50 years of experience in the pharmaceutical industry, Minakem has established itself as a trusted partner for companies looking to outsource their API development and manufacturing needs.

At Minakem, we understand that every project is unique, which is why we offer customized solutions tailored to meet our clients' specific requirements. Our team of experts works closely with our clients to develop innovative solutions that help them bring their products to market faster while ensuring compliance with regulatory standards.

Our state-of-the-art facilities are equipped with the latest technology, enabling us to provide high-quality services at competitive prices. We have a proven track record of delivering projects on time and within budget, making us the preferred choice for many pharmaceutical companies worldwide.

Our Services

Minakem offers a wide range of services designed to meet the needs of our clients throughout the entire drug development process. Our services include:

1. API Development: We offer comprehensive API development services from early-stage research through commercialization. Our team has extensive experience in developing complex molecules using various technologies such as biocatalysis, chiral synthesis, high-pressure hydrogenation, etc.

2. HPAPI Development: We specialize in developing highly potent APIs using advanced containment technologies such as isolators and gloveboxes. Our facilities are designed to handle HPAPIs up to OEL 4 level.

3. Custom Synthesis: We provide custom synthesis services for intermediates or reference compounds required during drug discovery or clinical trials.

4. Process Optimization: We optimize existing processes or develop new ones based on client requirements using Quality by Design (QbD) principles.

5. Analytical Services: We offer analytical method development/validation/transfer, stability studies, and release testing services to support our clients' drug development programs.

6. Commercial Manufacturing: We have the capability to manufacture APIs and HPAPIs at commercial scale in compliance with cGMP regulations.

Our Facilities

Minakem has four state-of-the-art facilities located in France, Belgium, and the United States. Our facilities are equipped with the latest technology and designed to meet regulatory requirements such as cGMP, FDA, EMA, etc. Our facilities include:

1. Research & Development Center: Located in Dunkirk (France), our R&D center is equipped with modern laboratories for API development and analytical services.

2. Pilot Plant: Located in Louvain-la-Neuve (Belgium), our pilot plant is designed for process optimization and small-scale production of APIs.

3. Commercial Manufacturing Facility: Located in Beuvry-la-Forêt (France), our commercial manufacturing facility is capable of producing APIs at a large scale.

4. HPAPI Facility: Located in Shawinigan (Canada), our HPAPI facility is designed to handle highly potent compounds up to OEL 4 level using advanced containment technologies such as isolators and gloveboxes.

Why Choose Minakem?

Choosing Minakem as your CDMO partner offers several advantages:

1. Expertise: With over 50 years of experience in the pharmaceutical industry, we have developed extensive expertise in API development and manufacturing.

2. Customized Solutions: We offer customized solutions tailored to meet your specific requirements throughout the entire drug development process.

3. Quality Assurance: We are committed to delivering high-quality services that meet or exceed regulatory standards such as cGMP, FDA, EMA etc., ensuring that your products are safe for patients worldwide.

4. Competitive Pricing: Our state-of-the-art facilities enable us to provide high-quality services at competitive prices while maintaining strict quality control measures throughout all stages of production

5. Timely Delivery: We have a proven track record of delivering projects on time and within budget, ensuring that your products reach the market faster.

Conclusion

Minakem is a fully integrated development partner (CDMO) and commercial manufacturer of APIs, Highly Potent APIs for pharmaceutical companies. With over 50 years of experience in the pharmaceutical industry, we have established ourselves as a trusted partner for companies looking to outsource their API development and manufacturing needs. Our customized solutions, state-of-the-art facilities, and commitment to quality assurance make us the preferred choice for many pharmaceutical companies worldwide. Contact us today to learn more about how we can help you bring your products to market faster while ensuring compliance with regulatory standards.