Skyepharma has 30 years of experience in the development of oral solid dosage forms. We provide a wide range of development services from feasibility studies to full formulation development. We also provide manufacturing services from scale up to commercial production of complex oral formulations. Our expertise covers complex forms in terms of formulation, supply chain and molecule.
We are investing also in our own development pipeline, to provide innovative solutions to answer current unmet needs in oral formulation such as bioavailability enhancement, biologics through oral route and targeted and extended release as well as colon targeting.

Our manufacturing facility is approved by EMA, US FDA, Korean Authorities, Anvisa. This allows us to bring significant experience working with the major regulatory authorities.

We are a CDMO solution provider for complex oral solid dosage for development, small scale and commercial manufacturing.

Our extensive and expert offer covers:
• Complex formulation of tablets and capsules
• Modified API release drugs
• HPAPI molecules
• Non sexual hormones production
• Bioproduction

Our value proposal offering shows a fully integrated program including:

Pharmaceutical Development
• Full Development Program: Scale-up from pilot to commercial of clinical trial material through our Pilot Plant,
• Pilot plant: cGMP, feasibility, technical batches, scale-up, troubleshooting,
• Analytical Services associated.

Manufacturing and packaging operations
• Manufacturing services for oral solid capsules and tablets, as well as powders, mini tablets, granules, Immediate or Modified released; film coated capsules,
• Manufacturing single, double or 3-layer capsules and dry-coated capsules,
• Commercial manufacturing of Oral drug products: Flexible batch sizes / Large capabilities/Tech. transfer capabilities for Solid dosage form,
• Packaging capabilities: Blister, Bottle filling / Serialization with aggregation.

Other services:
• QA-Release of CTM and commercial drug product,
• Analytical support: Development Method and validation, Method transfer, Development stability (all climatic conditions),
• Regulatory support: Internal competencies to support dossier filling,
• QP confirmation,
• Storage and Distribution.