Skyepharma presents
Expert and Innovative CDMO
Specialist of Complex Oral Solid Forms from development to manufacturing
Skyepharma is a French independent CDMO expert in complex oral solid forms pharmaceutical innovation orphan drugs highly potent drugs patient centric approach
Complex tablets and capsules
Our proprietary controlled release technologies
Complex molecule
Discover our contained cGMP HPAPI area
Complex supply chain
Global offering in OSD development and manufacturing
Skyehub-bioproduction
Built-on-demand, fully equipped GMP facility
Fully integrated, cGMP Industrial facility
We have a very strong regulatory track record with cGMP, FDA, ANSM and ANVISA approval enabling Skyepharma to deliver in more than 160 countries.
Our services
We offer a full range of services, from early stage development to industrial manufacturing and packaging.
Early-stage
Scale-up
Tech transfer
Manufacturing
Packaging
Regulatory services
Supply chain
Early-stage
Scale-up
Tech transfer
Manufacturing
Packaging
Supply chain
DEVELOPMENT
We have an extensive experience in solving complex formulation challenges with our innovative oral drug technologies.
MANUFACTURING
We do flexible batch sizes and offer large manufacturing and technology transfer capabilities for oral solid dosage forms.
PACKAGING
We offer customized packaging solutions for oral solid dosage forms : bottles, blisters including full serialization and aggregation.
REGULATORY SUPPORT
We have a dedicated department to support our partners in obtaining and maintaining approvals from authorities.
Contact-us
SKYEPHARMA PRESENTS
SKYEHUB BIOPRODUCTION
Agile and innovative solution for biotechnology development
– We make your biotech project come true –
Some of our key partners
Compatibility issues solving between several raw materials
Skyepharma develops pharmaceutical solutions that addresses the issue of incompatibility between several raw materials. Through its expertise, Skyepharma adopts an innovative approach to meet this need. Skyepharma is able to address the development needs all the way through to the production of clinical batches, enabling its partner to expand its product portfolio.
R&D support
Skyepharma offers R&D support for those who wishes to outsource this activity. Through a troubleshooting approach, Skyepharma offers an adapted solution so that its partner can implement it easily.
Quality product development
Skyepharma ensures the quality of the products developed for its partners. Through the implementation of Process Analytical Tools in the powder blending stages, Skyepharma saves development time for its partner while maintaining its quality standards.
Rare disease treatment development and manufacturing
Skyepharma supports its clients in the development and commercial manufacturing of orphan drugs. Thanks to its agility, Skyepharma quickly implemented internal processes that allow it to adapt to the low commercial volumes of its partner. Skyepharma also managed to meet the strategy and ambitious timelines associated with these high-value drugs by making the commercial product available within a month following its approval in the targeted markets.
Examples of some of our projects
Our global offering addresses a wide range of challenges, from bioavailability enhancement and API release control to the market introduction of new drug products and industrial manufacturing. With over 25 years of experience in OSD development and manufacturing, we have implemented processes focused on efficiency and optimizing time-to-market.
Our team of 217 employees includes a 1/4 of PhD-level professionals in chemistry and pharmaceuticals. Through our extensive network of partners with universities and research institutions, we continue to expand our expertise and consistently invest in innovation.
Why choose Skyepharma ?
We value enhanced time-to-market and cost reduction approach
We create robust process by applying "Quality by Design" methods
We offer a full range of services from development to manufacturing of various batch sizes
Our scientific expert team has a solid track-record of successful development, reformulation and transfer projects
Our GMP site located in France is FDA, ANVISA, ANSM approved, with a high level pharmaceutical quality environement
Our facility benefits from stand-alone equipement and is adapted for HPAPI molecules up to EOB5, as well as non-sexual hormones production and bioproduction
We own proprietary technologies and contantly invest in research and innovation
We work for international market with about 40% of our clients in US
We value enhanced time-to-market and cost reduction approach.
We create robust process by applying "Quality by Design" methods.
We offer a full range of services from development to manufacturing of various batch sizes.
Our scientific expert team has a solid track-record of successful development, reformulation and transfer projects.
Our GMP site located in France is FDA, ANVISA, ANSM approved, with a high level pharmaceutical quality environement.
Our facility benefits from stand-alone equipement and is adapted for HPAPI molecules up to EOB5, as well as non-sexual hormones production and bioproduction.
We own proprietary technologies and contantly invest in research and innovation.
We work for international market.
Contact-us
We attend global pharma business events
Pharma Synergy in London - February 5-6
Pharma Synergy London is a professional networking event that brings together leaders from the pharmaceutical, biotech, and life sciences sectors. Our Business Development Managers, 
Rosa Aldape Massard and Cathrin Herbert, will be there to meet partners from around the world and discuss how Skyepharma can address the unmet needs of pharmaceutical stakeholders in the areas of pharmaceutical formulation and manufacturing, HPAPI handling, and more.
Bio Europe in Lisbon - March 23-25
Bio Europe is Europe’s premier partnering conference for the biotechnology and pharmaceutical industries. It brings together biotech, pharma, and investment professionals to foster strategic partnerships, licensing opportunities, and knowledge sharing across the global life sciences sector. Meet there our Business Manager Rosa Aldape Massard.
To schedule a meeting with her, please contact us at partnership@skyepharma.com
Pharma Contract Manufacturing in Berlin - March 23-25
Pharma Contract Manufacturing is a leading industry event connecting pharmaceutical companies, contract manufacturers, and service providers. It focuses on collaboration, innovation, and solutions in drug development, formulation, production, and supply chain management.
Our client testimonials
