8 Calle de Einstein
Alcobendas, MD 28108
Spain
Company Description
YOUR PARTNER TO SUCCESS
SUANFARMA CDMO provides integrated end-to-end solutions for development and commercialization of Intermediates and Drug Substances for Small Molecules. We are specialists in helping pharmaceutical, biotech and healthcare companies by providing leading innovative integrated services that compress timelines to market, maximizing success.
ABOUT US
We are a true One-Stop Shop partner through supply chain and value chain solutions.
On the supply chain, our unique capabilities allow to combine GMP industrial processes of fermentation, purification and chemical synthesis for a wide variety of small molecules (APIs and intermediates) and companies (Pharma, Biotech or Healthcare). Our technologies and expertise support us in achieving success, whether the molecule is innovative or generic.
On the value chain, SUANFARMA CDMO services run from preclinical supply up to commercial manufacturing, enabling it to continue supporting our clients as they take molecules through development and onto the market.
At SUANFARMA CDMO we are guided by strict quality standards during all phases of production, from the selection of raw materials to manufacturing. Our facilities in Europe are in compliance with cGMP regulations requested by EMA and FDA standards.
We have worked on more than 37 different molecules, for more than 22 clients in Europe and other countries such as USA, Canada or Australia. Confidentiality, teamwork, flexibility and maximum communication are pillars of our work philosophy so that our client’s success becomes our success.
CAPABILITIES
FERMENTATION AND PURIFICATION:
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Small molecules fermentation and purification for human and veterinary use.
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Different type of facilities from highly automated to flexible production plants.
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Fermentation capacity with more than 2.000 m3.
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Technologies applicable to purification including centrifugation, L-L and S-L separators, RVF, microfiltration, chromatography, filtration and dryers.
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Pilot plant with optimized design to ensure the successful technology transfer and scaling-up phases.
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Expertise managing different kind of organisms for fermentative production processes and for different type of molecules/applications.
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Technical and GMP batches.
CHEMICAL SYNTHESIS:
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Small molecules chemical synthesis for human and veterinary use.
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Different type of facilities from highly automated to flexible production plants.
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Reaction capacity with more than 800 m3.
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cGMP Kilo-Lab for small scale processes.
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Expertise in complex chemical reactions, carbonylation, hydrogenation, distillation, crystallization, cryogenic reactions, and for a wide variety of drug substances.
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Stainless steel reactors, Hastelloy, special alloy and glass lined equipment, available for your projects.
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Technical and GMP batches.
Contract Service Categories
Contract Services Directory
| Accelerated Stability Studies |
| Analytical Laboratory Services |
| Analytical Methods Development |
| Analytical Validation Studies |
| cGMP Synthesis |
| Chemical Analysis |
| Chemicals and Raw Materials |
| Clinical Supply Management |
| Clinical Trials, Phase I |
| Clinical Trials, Phase II |
| Clinical Trials, Phase III |
| Clinical Trials, Phase IV |
| CMC (Chemistry, Manfacturing & Controls) |
| Commercial Drug Sourcing |
| Contract Development and Manufacturing Organization (CDMO) |
| Contract Manufacturing |
| Custom Fabricators |
| Custom Manufacturing |
| Custom Synthesis |
| Distribution, Commercial |
| DMF Establishment / Maintenance |
| Downstream Processing |
| Drug Development Services |
| European QP |
| Fermentation |
| Fluid Bed Processing |
| HPLC |
| IND/NDA Submissions |
| Lot Release Testing |
| Lyophilization |
| Manufacturing, API |
| Manufacturing, Clinical Trials Supply |
| Manufacturing, Custom |
| Manufacturing, Generics |
| Manufacturing, Lyophilized Products |
| Manufacturing, Other |
| Manufacturing, Parenterals, Small Volume |
| Mass Spectrometry |
| Methods Development |
| Methods Validation |
| Microbial Fermentation |
| Preclinical Testing |
| Process R&D |
| Project Management |
| Purification |
| QA/QC |
| Quality Control Testing |
| R&D Services |
| Scale-Up |
| Shipping |
| Supplier, Fine Chemicals |
| Supplier, Raw Materials |
| Supply Chain Management |
| Technology Transfer |
| Validation, Clinical |
| Validation, Manufacturing |
