Development And Manufacturing Of Oral Solid Dosage Forms

Your trusted partner for the development and manufacturing of tablets and capsules

• Speed to market: We accelerate development timelines for OSD projects and enable fast, seamless technology transfers from development to commercial manufacturing.
• End-to-end support: Integrated services for oral solids from early-phase development to commercial manufacturing and packaging throughout the entire product life cycle.
• Expertise: More than 30 years of experience supporting complex oral solid dosage form projects, including modified-release and highly potent products.

Our oral solid dose CDMO services

Pharmaceutical development​

Siegfried provides pharmaceutical development services for complex oral solid dosage forms, from formulation design to scalable manufacturing processes. Our expertise includes:

• highly potent APIs (HPAPIs),
• controlled substances,
• narcotics and modified-release formulations, supported by advanced development technologies.

We support second- and third-generation formulations to enable lifecycle management and long-term product success.
APIs can be supplied either by our customers or by Siegfried’s integrated drug substance development and manufacturing teams, enabling seamless collaboration from API development to finished drug product manufacturing. Early API specification alignment supports efficient formulation development and smooth downstream manufacturing.

Analytical development

Our experienced drug product analytical development team supports projects with cGMP-compliant testing throughout the entire development lifecycle. Working closely with our drug substance analytics team, we ensure seamless analytical support from early development through commercial manufacturing and packaging.

Backed by the resources of our global network, our analytical services range from development activities and formulation support to stability testing, method validation, and commercial GMP batch release testing.

Scale-up and clinical trial material production

We support rapid and seamless scale-up from development to clinical and pilot-scale manufacturing, regardless of whether the formulation is new, modified, or transferred from an existing process.

Siegfried offers cGMP manufacturing capabilities ranging from very small quantities to pilot-scale batches based on project requirements.

Clinical trial manufacturing at our Barberà del Vallès site is certified by national and international authorities and supported by highly qualified GMP teams.

Process and analytical method transfer

Siegfried designs scalable processes from the earliest stages of development. Standardized equipment platforms across multiple scales enable efficient transfer from laboratory to commercial manufacturing.
We support process and analytical method transfer to Siegfried sites or customer-selected manufacturing locations.

• Analytical method transfer and cleaning validation
• Production process transfer and scale-up
• Process qualification and validation
• Registration batch and CTM manufacturing
• Packaging and stability testing
• Regulatory and lifecycle management support

Commercial manufacturing and packaging

Siegfried offers commercial manufacturing and packaging services across a wide range of oral solid dosage forms, including highly potent products.

Manufacturing capabilities

• Granules and powder mixtures
• Pellets and mini-tablets
• Film-coated tablets and pellets
• Hard capsules
• Highly potent tablets and capsules
• Inhalation capsules

Packaging capabilities

Primary packaging:

• HDPE bottles
• Thermoform and cold-form blisters
• Peel-off and anonymous blisters

Secondary packaging:

• Serialized bottle labeling
• Tamper-evident folding boxes
• Wallet packaging
• Print-on-demand labeling

Tertiary packaging:

• Bundling and aggregation
• Shipper case packaging and pallet aggregation
• boxes (automated device insertion available)

Technical capabilities

From early development and CTM-scale production to large-scale commercial manufacturing, Siegfried offers advanced technology platforms for standard and highly potent APIs.

Core OSD manufacturing

• Blending
• Wet and dry granulation
• Fluid bed processing
• Pellet extrusion and spheronization
• Tablet compression
• Coating technologies
• Hard capsule filling

Advanced technologies

• Spray drying and lipid-based delivery systems
• Pin milling and nano milling
• Low-humidity processing
• Organic solvent handling

Packaging and market readiness

• Blister and bottle packaging
• Serialization and aggregation

Facilities and compliance

• State-of-the-art equipment platforms
• Refrigerated storage capabilities
• Globally inspected and approved facilities
• Controlled substance handling licenses