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Pharma Services Category of Minakem

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API Development

Contract Manufacturing

Custom Synthesis & Manufacturing

High Potency APIs (HPAPIs)

Hydrogenation

Low Temperature / Cryogenic conditions

Lyophilization

Scale Up

Small Scale Batch

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Minakem

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BELGIUM

Virtual BoothCDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Synthetic Research & Process Development

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- Service Details

Minakem High Potent's R&D department main functions include synthetic research and process development; analytical research and development; continuous improvement.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Process Development & Optimization

Virtual BoothCDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

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- Service Details

Minakem High Potent's dedicated R&D team helps chemical developments, route scouting process optimizations, industrialization.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Route Evaluation & Development

Virtual BoothCDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Development of HPAPIs

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- Service Details

Minakem facility in Louvain-la-Neuve has pioneered from the late 90’s the utilization of containment technology (closed systems) for the production of HAPIs.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: High Potency APIs (HPAPIs)

Virtual BoothCDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Contract Manufacturing of Highly Potent APIs

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- Service Details

Minakem provides fully integrated and technology-oriented contract manufacturing services ranging from process development, kilo lab & pilot scale-up through to full industrial scale manufacturing of complex molecules including HPAPI’s.

- Directory Listing

Pharma Service: API Manufacturing

Category: Contract Manufacturing

Sub Category: Overview

Virtual BoothCDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Multi-Scale Up Capacities

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- Service Details

Minakem provides fully integrated and technology-oriented contract manufacturing services ranging from process development, kilo lab & pilot scale-up through to full industrial scale manufacturing of complex molecules including HPAPIs.

- Directory Listing

Pharma Service: API Manufacturing

Category: Scale Up

Sub Category: Overview

Virtual BoothCDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Custom Synthesis & Manufacturing of HPAPIs

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- Service Details

Minakem offers state-of-the-art high containment manufacturing facility to handle from early-stage development to scale-up & commercial manufacture of high potent APIs with occupational exposure limits (OEL) below to 0.1?g/m³/shift (OEB class 6).

- Directory Listing

Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

Virtual BoothCDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Capability to Handle Potent Compounds

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- Service Details

Minakem offers state-of-the-art high containment manufacturing facility to handle from early-stage development to scale-up & commercial manufacture of high potent APIs with occupational exposure limits (OEL) below to 0.1?g/m³/shift (OEB class 6).

- Directory Listing

Pharma Service: API Manufacturing

Category: High Potency APIs (HPAPIs)

Sub Category: Overview

Virtual BoothCDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Low Temperature Capabilities (Up to -80°C)

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- Service Details

Minakem is a leader in certain technologies including flow reactions, hazardous chemistry, HPAPIs, including cytotoxic molecules, and low-temperature chemistry.

- Directory Listing

Pharma Service: API Manufacturing

Category: Low Temperature / Cryogenic conditions

Sub Category: Overview

Virtual BoothCDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Hydrogenation Capabilities

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- Service Details

Minakem High Potent (MHP), a recognized world leader custom manufacturer for development and commercialization of Highly Potent APIs (HAPI), also offers hydrogenation capabilities.

- Directory Listing

Pharma Service: API Manufacturing

Category: Hydrogenation

Sub Category: Overview

Virtual BoothCDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Small Scale Production Capacities

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- Service Details

Minakem provides fully integrated and technology-oriented contract manufacturing services ranging from process development, kilo lab & pilot scale-up through to full industrial scale manufacturing of complex molecules including HPAPIs.

- Directory Listing

Pharma Service: API Manufacturing

Category: Small Scale Batch

Sub Category: Overview

Virtual BoothCDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Freeze-Drying Capabilities

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- Service Details

Minakem High Potent (MHP), a recognized world leader custom manufacturer for development and commercialization of Highly Potent APIs (HAPI), also offers Cryogenic process capabilities, freeze-drying technologies and capacities

- Directory Listing

Pharma Service: API Manufacturing

Category: Lyophilization

Sub Category: Overview

Pharma Services Category of Minakem

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