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 biotechnology development pharmaceutical innovation

Complex tablets and capsules

Multi-layer, mini-tabs, modified release, multi-API-combo

Our proprietary controlled release technologies

Press-coated tablets, multi-layer tablets, gastro-retentive capsule
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Complex molecule

Highly Potent API, oncology, controlled substances, non-sexual hormones

Discover our contained cGMP HPAPI area

Our plant is equipped with a segragated cGMP area for OEB 4/5+ molecules, NCE, immuno/oncology drugs for both develoment and manufacturing
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Complex supply chain

Orphan drugs, rare diseases, wide range of batch size

Global offering in OSD development and manufacturing

From R&D, clinical supply and small/mid-size commercial production to industrial scale, all in cGMP environnement

Skyehub-bioproduction

Unique and tailor-made biotechnology support offer

Built-on-demand, fully equipped GMP facility

To support you from early-stage development to the industrial stage
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We are heading to CPHI

Ready to schedule an appointment with our team? We would be happy to meet you in Frankfurt at our booth D44, Hall 6.1.

CPHI

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

R&D

DEVELOPMENT

We have an extensive experience in solving complex formulation challenges with our innovative oral drug technologies.

Manufacturing OSD

MANUFACTURING

We do flexible batch sizes and offer large manufacturing and technology transfer capabilities for oral solid dosage forms.

Packaging

PACKAGING

We offer customized packaging solutions for oral solid dosage forms : bottles, blisters including full serialization and aggregation.

Regulatory support

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.

GMP
FDA
ANVISA
ANSM

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.

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.

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.

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

Meet our super team at the booth 6.1D44

Our client testimonials

“Thank you for this daily report which is more than reassuring when I see these two grains. Good work to the whole team, these grains have no more secrets for you ! "
Bayer
Bayer
“We have reviewed the report and find it really ell written. The results has helped us to make decisions around how to move on with the current formulation. At this stage, we will need to scale-up and continue with preparing for our newt clinical production.”
Calliditas
Calliditas
"Expertise on complex dosage oral formulations with qualified staff and nice facilities (site FDA agreed). The reactivity of the team and closely project follow up are highly appreciated"
Bioprojet
Bioprojet Pharma

LET'S MEET AT CPHI 2025 !

Date: October 28-30th, 2025 | 9:00 AM – 6:30 PM

Location: Booth D44, Hall 6.1.