Custom Manufacturing & CDMO Partnerships
Through our trusted global network of GMP-certified partners, Sky Pharma FZE offers custom manufacturing solutions for APIs and finished dosage forms—supporting scale-up, technology transfer, and commercial supply.
Pharmaceutical innovation often requires tailored manufacturing capabilities beyond standard supply. Sky Pharma FZE connects clients with Contract Development and Manufacturing Organizations (CDMOs) to provide flexible, compliant, and cost-effective solutions for complex projects.
From laboratory scale to commercial volumes, we ensure your product is manufactured in line with international regulatory standards and delivered with full technical and quality support.
Our Capabilities
Custom Manufacturing Services We Provide
API Manufacturing:
Custom synthesis, scale-up, and optimization.
Intermediates:
Development and production of critical intermediates.
Finished Dosage Forms (FDFs):
Tablets, capsules, injectables, and specialized formulations.
Technology Transfer:
Smooth transfer from R&D to GMP commercial scale.
Process Development:
Route scouting, impurity profiling, and cost optimization.
Packaging & Labelling:
Market-specific packaging, serialization, and compliance with EU/UK/MENA regulations.
Partnership Approach
Flexible Collaboration With Trusted Partners
We work with a network of audited CDMOs across Europe, Asia, and MENA, allowing us to:
- Match each project to the most suitable partner site.
- Ensure GMP and GDP compliance across all facilities.
- Negotiate competitive timelines and costs.
- Provide project management support from initiation to delivery.
This partnership approach ensures transparency, reliability, and accountability at every step.
Industries We Support
Serving a Wide Range of Clients
Our CDMO services support companies of all sizes, including:
- Generic manufacturers requiring bulk API production.
- Biotech & specialty pharma developing niche molecules.
- Contract manufacturers (CMOs) needing capacity extension.
- Distributors & institutions seeking custom-labelled FDFs.
Regulatory & Quality Framework
Built-In Compliance for Global Markets
Every custom manufacturing project is delivered with regulatory and quality oversight. Depending on the scope, documentation may include:
- GMP certificates of partner sites
- CoAs, stability, and impurity data
- DMF/CEP submissions for APIs
- CTD/eCTD dossiers for FDFs
- Serialization and labelling compliance records
Why Choose Sky Pharma for CDMO Support
Your Trusted CDMO Partner
Global Network
Access to qualified CDMOs across EU, Asia, and MENA.
Flexible Models
From pilot batches to full-scale commercial production.
Regulatory Assurance
GMP-compliant, audit-ready facilities.
Project Management
End-to-end oversight from initiation to delivery.
Bring Your Pharma Project to Life With Sky Pharma FZE
From custom APIs to finished dosage forms, our CDMO partnerships deliver compliant, efficient, and scalable manufacturing solutions.
