Early stage formulation Development & Process Design
Product Description
Skyepharma Production S.A.S
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FR
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2017On CPHI since
Categories
Skyepharma Production S.A.S
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FR
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2017On CPHI since
More Products from Skyepharma Production S.A.S (15)
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Product Geomatrix® Technology_Customisable drug delivery platform
Geomatrix® provides a customisable drug delivery platform for controlled release versions of orally available molecules. The combination of layers, each with different rates of swelling, gelling and erosion, controls the drug release rate within the body Geomatrix® is is currently used in 8 produ... -
Product Soctec® Technology_Self Orienting Capsule Technology
Soctec® was developed for drugs that need to be retained in the stomach for an extended period of time to then being slowly released either for a local effect in the stomach or for absorption in the upper intestine. Soctec® is a versatile extended release gastro-retentive platform technology that ... -
Product Medicated chewing gum technology
Our proprietary medicated chewing gum technology uses an approach similar to multilayer tableting. A combination of layers modulates the release rate of the active ingredients and flavouring agents when the gum is chewed. -
Product Microfluidizer technology
By using microfluidization technology process, Skyepharma provides solution to increase bioavailabity of poorly soluble APIs (micro and nanoparticule). It is also an interesting technology for micro and nano emulsion manufacturing. -
Product Regulatory services
NDA/ANDA MAA-CTD writing Regulatory support -
Product Worldwide production and supply (US, EU, Russia, Asia/Pacific, EMEA, Latam)
Certifications : FDA, Europe, ANVISA, Korean FDA etc. -
Product Clinical trial material (CTM) manufacturing and release
We offer capabilities for manufacturing of small and large scale clinical trial material (CTM) as well as characterization and release from phase 1 to phase 3. -
Product Manufacturing of complex and classic oral solid dosage forms
Manufacturing of classic and complex oral solid dosage forms: single layer tablets, multi-layer tablets, tab-in-tab, tab-in-caps, hard gel capsules, powder & pellets. -
Product Analytical Development and expertise
Our analytical experienced team support the pharmaceutical development during every phase of the development process. Analytical development transfer and validation, characterization capabilities, stability analysis, ICH Q3D (residuals solvent risk assesment), ICHQ3C (elemental impurities risk assesment... -
Product Scale-up and Quality by Design (QbD) processes
Skyepharma is experienced with the scale-up of complex oral solid dosage forms from laboratory to pilot-scale and full commercial scale manufacturing. We have powerfull compaction simulation tools ( STYL'One evolution) allowing to derisk and fasten scale-up steps.
Our capabilities :... -
Product Packaging in Blister
Primary packaging: Forming station for both PVCs and aluminium and all kind of feeder for tablets and capsules. Secondary packaging: Labelling, carton and casepacker. -
Product Packaging in Bottle
Primary packaging : Plastic and glass bottles (round and square) loading station. Secondary packaging : sealing, labelling, carton and casepacker.
Skyepharma Production S.A.S resources (2)
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News Skyepharma selects Veratrak platform to ensure secure data storing and sharing
Using Veratrak's platform, the CDMO will have full oversight of data, including an audit trail of data and document processes -
Whitepaper Recent development in complex tablet formulation design
In this article, Mathieu Degomme, PharmD, Pharmaceutical Development Project Manager, and Aline Moulin, PhD, Pharmaceutical Development Director, both of Skyepharma, outline three case studies from recent early-stage development programmes to illustrate what kind of complex tablets can be developed to meet specific target dissolution profiles for versatile applications.
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