Highly Potent API, Oncological, Immuno-oncology drugs, and NCEs
Product Description
Skyepharma Production S.A.S
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Country/Region:France
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On CPHI since:2017
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Certificates:3
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Employees:100 - 249
Company types
Primary activities
Categories
Specifications
Skyepharma Production S.A.S
-
Country/Region:France
-
On CPHI since:2017
-
Certificates:3
-
Employees:100 - 249
Company types
Primary activities
More Products from Skyepharma Production S.A.S (15)
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Product Geoclock® Technology_Customisable chronotherapy
Geoclock® allows for timed release of drugs that is independent of food or pH. Geoclock® is a validated oral drug delivery technology that can be used to release the drug from the tablet after a pre-determined lag-time that is independent of food or pH. Geoclock® can additionally be used for multi... -
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 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, Asia/Pacific, EMEA, Latam)
Certifications : FDA, Europe, ANVISA, Korean FDA etc. -
Product Early stage formulation Development & Process Design
We have extensive experience in solving complex formulation challenges. Our experts can apply our extensive range of proprietary technologies for immediate (IR) and modified (MR) / sustained, slow (SR) / controlled (CR) / extended (XR, ER) / pulsed / timed release as well as enteric and gastro reten... -
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.
Skyepharma Production S.A.S resources (14)
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News Skyepharma: The French CDMO Advances Strategic Growth Through Leadership and Shareholder Transition
Bertrand SIMON and Hervé Letoublon acquire 100% of the company’s shares, Sébastien Mas becomes the new CEO of Skyepharma. -
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. -
Brochure Company brochure
Through 25 years of involvement and achievements in the pharmaceutical industry, Skyepharma’s development and manufacturing facility is a leader in the field of classic and complex oral solid dosage forms. -
Brochure Skyepharma booklet of services
We support our clients through the whole product value chain with expert teams involved at the very beginning of every project. - Pharmaceutical development services - Technology offer for complex oral solid forms - Analytical services - Manufacturing & packaging capabilities - Serialization & aggregation service ready -
Whitepaper CPHI 2018_Pharma Insight Briefings
Aline Moulin, Head of New Product Introduction Department (NPI), presented different case studies during the Pharma Insight Briefings 2018 (CPHI Worldiwide): "COMPACTION SIMULATION AS A POWERFUL QUALITY BY DESIGN (QbD) TOOL How Skyepharma can help you to shorten the time and reduce the cost of pharmaceutical development programmes" -
Whitepaper CPHI 2017_Pharma Insight Briefings
Lucile Kowalsky, Project Manager in the New Product Introduction (NPI) department presented a case study during the Pharma Insight Briefings (CPHI Worldwide 2017) : "Quality by Design and Expertise:Accelerating time to market of complex oral solid dosage Accelerating time to market." -
Brochure Corporate website
Welcome to our corporate website ! -
Video Skyepharma - Packaging services 2020
- Bottle packaging - Blister packaging
- Stick-packs
- Serialization & aggregation services (Seavision systems) -
Video Skyepharma - "What do we mean by Agile CDMO ?"
For Skyepharma, to be agile qualifies our ability to mobilize experts and work together to solve complex efficiently and rapidly. Skyepharma, your AGILE CDMO partner for tailor-made solutions. -
Video Skyepharma - "What do we mean by Reliable CDMO ?"
For Skyepharma, being reliable means taht we are able to meet our customers' needs on time and to the expected level of quality. Skyepharma your reliable CDMO for faster time to market without compromising on product quality -
Whitepaper Analytical Development & Technico Regulatory Expertise
We are able to develop analytical methods in a limited time, from bibliography study, screening parameters and conditions to sample preparation and assessment of robustness.











