Oral Solid Dosage Forms Manufacturing
From classic forms to complex and highly potent drug products
Skyepharma is a French CDMO with full manufacturing capabilities for oral solid dosage forms all in cGMP compliant environment. We manufacture granules, tablets, powders, pellets and capsules, as well as complex forms such as tab-in-tab, tab-in-cap, cap-in-cap and multilayer tablets, with batch sizes from 1 g to 700 kg and containment up to OEB5.
From pilot and clinical batches to industrial scale, bring complex oral solid dosage programmes under one roof.
Our OSD manufacturing offering at a glance
Each step of the manufacturing process is controlled and carried out in compliance with pharmaceutical industry quality standards.
| DOSAGE FORMS | Granules, tablets, powders, pellets, capsules |
| COMPLEX FORMS | Tab-in-tab, multilayer tablets, tab-in-cap, mini-tablets, cap-in-cap, orally disintegrating forms, powder for nasal devices |
| BATCH SIZE RANGE | From 50g to 700kg |
| SCALES | Pilot, clinical, industrial |
| CONTAINMENT | For HPAPI classes L, G and H we offer dedicated and contained OEB 4/5 area |
| SPECIALTIES | Oncology drug products, L, G and H molecules, non-reproductive hormonal drugs, immunological drugs, orphan drug products, delayed-release technologies, and fixed-dose combination technologies |
| INNOVATIONAL PROGRAMS | Controlled-release, targeted-release, fixed-dose combination, bioavailability enhancement, and solubility enhancement technologies, orally disintegrating tablets |
| TARGETED POPULATION | Adult, pediatric, geriatric, orphan drug patients, dysphagia patients, immunocompromised patients, clinical trial population |
| GEOLOCATION | Saint-Quentin-Fallavier, France (near Lyon) |
| APPROVALS | ANSM, GMP, FDA, ANVISA, PMDA |
| LAST GMP INSPECTION | 2026 |
Our manufacturing services
From simple forms to highly potent products : end-to-end oral solid dose manufacturing under one roof.
Pilot and clinical scale manufacturing
Batches from 50 g in cGMP environment
Smooth technology transfer
QbD approach to move your formulation into manufacturing
Industrial scale manufacturing
Up to 700 kg per batch in cGMP environment
Highly potent drugs up to OEB5
Fully contained and segregated areas for HPAPIs (L-G-H)
Orphan drug manufacturing
Dedicated capacities for orphan drug products
Hormonal drug manufacturing
Manufacturing of non-reproductive hormonal drugs
What oral solid dosage forms can we manufacture?
Uncoated / coated single layer tablets
Marketed Geoclock® technology for timed release of active ingredients, unaffected by food or pH levels. Two tablet components combined into a single oral solid dose form.
Marketed Geomatrix® technology with 8 products available in over 80 countries. Two main applications: single-API formulations, mixed-release profiles and API-combinations.
Uncoated or coated, single-layer tablets with a diameter of 2-4 mm, enabling flexible dosing for patients who may have difficulty swallowing conventional tablets.
Capsules filled with powder, granules or pellets
Tab-in-cap technology enables the combination of different drugs and release profiles in one capsule, supporting tailored drug delivery, improved treatment convenience, and potentially better therapeutic outcomes.
Gastro-retentive bicapsules featuring Soctec technology, designed to prolong gastric residence and ensure controlled drug release for improved absorption in the upper intestine or localized action in the stomach.
Combine different drug-release mechanisms and separate incompatible ingredients, while optimizing drug delivery within a single dosage form.
Benefit from flexible dosing, versatile administration, and tailored drug delivery with powder formulations, offering potential advantages in dissolution, stability, and patient compliance.
Pellet technology enables greater robustness against certain formulation-related release variations than single-unit systems.
Skyepharma’s offering includes aqueous and organic granulation and roller compaction.
Seamless manufacturing expertise from pilot to industrial scale
From raw materials to finished medicines for up to OEB5 drug products
Microfluidisation
Produces uniform particles and nanoparticles by controling fluid flows at the microscale
Equipment in the conventional GMP area
Wet granulation
Binds the powder with a liquid solution to form granules with improved flow and compressibility
Equipment in the conventional GMP area and HPAPI drug containment zone
Extrusion
Shapes the material into strands or profiles for further processing
Equipment in the conventional GMP area
Drying
Removes solvent or moisture to achieve the desired water content and stability
Equipment in the conventional GMP area and HPAPI drug containment zone
Roller compaction
Compresses the dried material into flakes, improving density and uniformity
Equipment in the conventional GMP area and HPAPI drug containment zone
Milling
Reduces particle size to the desired range for optimal flow and compressibility
Equipment in the conventional GMP area and HPAPI drug containment zone
Lubrication / Blending
Adds lubricant(s) and blends the components to ensure proper flow and tabletability
Equipment in the conventional GMP area and HPAPI drug containment zone
Tableting
Compresses the powder blend into tablets of consistent weight, hardness and quality
Equipment in the conventional GMP area and HPAPI drug containment zone
Capsule filling
Fills empty capsules with the prepared powder or granules
Equipment in the conventional GMP area and HPAPI drug containment zone
Film coating
Applies a protective and functional coating to improve appearance, stability and swallowability
Equipment in the conventional GMP area and HPAPI drug containment zone
Contact-us
This form is reserved for business and partnership inquiries. To apply for our job offers, please check our Careers page.
FAQ
Can you formulate two incompatible APIs in the same tablet ?
Skyepharma has an expertise in formulation of two incompatible APIs in the same tablet by using physical separation strategies, as tablet-in-tablet, multilayer tablets, coated pellets and mini-tablets technologies, to prevent direct contact between the active ingredients while maintaining the stability and performance of the final dosage form.
What modified-release technologies does Skyepharma offer?
Skyepharma offers several proprietary controlled-release technologies. Some are commercially established and used in the manufacture of marketed drug products, while others are at the clinical development stage.
To learn more, please visit our Modified-Release Technologies page.
Does Skyepharma provide manufacturing capacities for orphan drugs ?
To answer the unmet needs of orphan drug companies, our CDMO offering include:
– Flexible production volumes: from smaller batches to changing demand.
– A dedicated packaging line for orphan drugs, tailored to answer specific product requirements.
– Bright stock capabilities with unlabelled, fully packaged products ready for final labelling and market-specific customisation, helping simplify supply chain management and support flexibility across different markets.
– Dedicated OEB 4/5 containment area to support the safe handling of highly potent compounds.
Is it possible to manufacture vitamins at Skyepharma?
Yes.
What is Skyepharma's MOQ (minimum order quantity) policy?
Flexible, depending on the product and process
Does Skyepharma offer clinical and commercial supply under one quality system?
Yes. Skyepharma supports clinical and commercial supply within an integrated cGMP manufacturing and pharmaceutical quality environment.