Skyepharma presents
Expert and Innovative CDMO
Specialist of Complex Oral Solid Forms from development to manufacturing
Skyepharma is a French Independent CDMO for Complex Oral Solid Forms
From early-stage pharmaceutical development to cGMP industrial manufacturing, we support pharmaceutical companies worldwide in bringing innovative drugs to market, including modified-release formulations, highly potent drugs (HPAPI), orphan drugs, and patient-centric solutions.
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
Services of our CDMO
We offer a full range of services, from early stage development to industrial manufacturing and packaging.
PHARMACEUTICAL DEVELOPMENT
We have an extensive experience in solving complex formulation challenges with our innovative oral drug technologies.
PHARMACEUTICAL MANUFACTURING
We do flexible batch sizes and offer large manufacturing and technology transfer capabilities for oral solid dosage forms.
PHARMACEUTICAL 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.
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.
SKYEPHARMA PRESENTS
SKYEHUB BIOPRODUCTION
Agile and innovative solution for biotechnology development
– We make your biotech project come true –
Some of our key pharmaceutical 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 CDMO 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.
Contact-us
We attend global pharma business events
CDMO Live in Rotterdam – May 19–21
UK Biotech Day in London – May 27–28
BayOconnect in Munich – June 30 – July 1
NLS in Stockholm – September 8–9
CPHI in Milan – October 6–8
Orphan Drug Congress in Amsterdam – October 26–28
Our client testimonials
FAQ about Skyepharma CDMO Services
What types of oral solid forms does Skyepharma manufacture?
Skyepharma specializes in complex oral solid dosage forms including multi-layer tablets, press-coated tablets, mini-tablets, modified-release capsules, gastro-retentive formulations, and multi-API combination products.
Is Skyepharma FDA approved?
Yes. Skyepharma holds cGMP certification and is approved by the FDA (USA), ANSM (France), and ANVISA (Brazil), enabling product distribution in over 160 countries.
Does Skyepharma handle highly potent APIs (HPAPI)?
Yes. Skyepharma operates a segregated cGMP containment area for OEB 4/5+ molecules, covering oncology, immuno-oncology, controlled substances, and non-sexual hormones, for both development and commercial manufacturing.
Where is Skyepharma located and which markets does it serve?
Skyepharma is headquartered and operates its cGMP manufacturing facility in France, within the heart of Europe’s pharmaceutical industry. Despite its French base, Skyepharma is a truly global CDMO partner:
- Products manufactured at Skyepharma are commercialized in over 160 countries
- We serve clients from Europe, North America, Latin America, the Middle East, and Asia-Pacific
- Our FDA, ANSM, and ANVISA approvals provide direct market access to the US, EU, and Brazilian markets — with indirect access to many additional countries that reference these certifications
- All project management and scientific communication is conducted in English and French
Does Skyepharma work with small biotech companies or only with large pharmaceutical groups?
Skyepharma is headquartered and operates its cGMP manufacturing
facility in France, within the heart of Europe’s
pharmaceutical industry. Despite its French base, Skyepharma
is a truly global CDMO partner:
- Products manufactured at Skyepharma are commercialized
in over 160 countries - We serve clients from Europe, North America, Latin America,
the Middle East, and Asia-Pacific - Our FDA, ANSM, and ANVISA approvals provide
direct market access to the US, EU, and Brazilian markets with indirect access to many additional countries that reference
these certifications - Our business development team speaks English, French, Spanish and German
How does Skyepharma ensure confidentiality and protect clients' intellectual property?
As an independent CDMO with no proprietary drug portfolio,
Skyepharma has no competitive interest in its clients’ molecules.
This independence is a fundamental guarantee of confidentiality.
Our IP protection framework includes:
- Systematic execution of mutual Non-Disclosure Agreements (NDA/CDA) before any technical exchange
- Segregated project teams with access controls to prevent information sharing between client projects
- Secure IT infrastructure with access-restricted electronic document management systems
- Clear contractual ownership clauses ensuring all developments, formulations, and data generated belong to the client
What is the difference between a CDMO and a CMO?
A CMO (Contract Manufacturing Organization) focuses on manufacturing only, while a CDMO (Contract Development and Manufacturing Organization) like Skyepharma provides both pharmaceutical development services and cGMP manufacturing under a single roof.
What is the typical timeline from first contact to first clinical batch at Skyepharma?
Timelines vary depending on the complexity of the molecule and
the dosage form, but as a general indication:
- Feasibility & preformulation study: 2–4 months
- Prototype development & optimization: 3–6 months
- Analytical method development & validation:
2–4 months (can run in parallel) - Clinical batch manufacturing (Phase I):
1–3 months after formulation lock
From first contact to first clinical batch, a realistic timeline
for a complex oral solid form is typically 9 to 18 months,
depending on API availability, regulatory requirements, and formulation
complexity. Skyepharma’s integrated approach Iis based on combining development and manufacturing under one roof that eliminates the time lost in external technology transfers and accelerates this timeline significantly.
What is a technology transfer in pharmaceutical manufacturing and how does Skyepharma manage it?
A pharmaceutical technology transfer is the formal process by which a manufacturing process along with all associated knowledge, documentation, and analytical methods is transferred from
one site to another. Technology transfers occur when:
- A drug company moves production from an internal facility
or another CDMO to Skyepharma - A product developed in Skyepharma’s R&D lab is scaled up to our commercial manufacturing unit
- A product transitions from clinical to commercial manufacturing
Skyepharma’s technology transfer process follows ICH Q10 guidelines
and is managed by a dedicated team of formulation scientists and
process engineers. Our approach includes:
- Comprehensive gap analysis between sending
and receiving site equipment and processes - Development of a detailed Technology Transfer Plan (TTP)
with defined milestones and acceptance criteria - Process validation runs with statistical analysis to confirm process robustness
- Full regulatory documentation package (site master file updates, variation filings if applicable)
How do I select the right CDMO for my oral solid drug product?
Selecting a CDMO is a critical strategic decision. The key criteria
to evaluate when choosing a CDMO for oral solid dosage forms include:
- Technical expertise: Does the CDMO have proven
experience with your specific dosage form type (modified release, HPAPI,
combination product)? - Regulatory approvals: Is the facility approved
by the health authorities relevant to your target markets (FDA, EMA, etc.)? - Integration: Can the CDMO handle both development
and manufacturing to avoid costly technology transfers between partners? - Capacity fit: Does the CDMO have appropriate
batch sizes for your volume needs — from clinical supply to commercial scale? - Track record: How many products has the CDMO
successfully brought to market? What is their regulatory inspection history? - Independence: Is the CDMO independent (no competing
drug portfolio), ensuring full alignment of interests? - Communication and project management: Will you
have a dedicated project manager and transparent reporting?
Skyepharma meets all of these criteria as a dedicated, independent French CDMO with 25+ years of experience, multi-regulatory approval, and a fully integrated development-to manufacturing platform.