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Oral solids

Our experienced formulation development teams support commercial development and manufacturing strategies across a wide range of drug programs.
Our experienced formulation development teams support commercial development and manufacturing strategies across a wide range of drug programs.

Your most trusted partner for oral solids

Expertise

Extensive knowledge in handling highly potent APIs

Reliability

Resilient and reliable supply chains supported by our global network

Agility

Customized solutions and flexibility to deliver challenging projects

Our wide range of services for OSD

Pharmaceutical development

Siegfried offers a broad range of pharmaceutical development services from intricate formulations, including demanding narcotic or highly potent active pharmaceutical ingredients (HPAPIs), to the creation of robust manufacturing processes and the incorporation of cutting-edge technologies. Our expertise extends to the development of second and third-generation formulations, strategically designed to support product life cycle management, ensuring continued success and innovation.

We can process APIs provided by our customers or by our drug substance custom development and manufacturing team. The API specifications are pre-defined in the early phase to achieve formulation efficiency.

Analytical development

Our well-experienced drug product analytical development team supports development projects with cGMP-compliant analyses, working with their counterparts covering drug substances to support your product at every phase in the development process. With access to the analytical resources of our global network, analytical services range from development activities, formulation support, stability testing to method validation and commercial GMP batch release testing.

Scale-up and clinical trial material production

We take your process to the next manufacturing level quickly and smoothly regardless of your starting point, whether it is a new, modified or existing formulation generated by our pharmaceutical development team. Siegfried offers cGMP-manufacturing of all scales ranging from very small quantities to pilot scale batches depending on your specific needs.

Siegfried offers drug product clinical trial manufacturing under cGMP conditions at our Barberà del Vallès site, certified by national and international authorities. Our qualified team approves all GMP relevant documents and prepares the market release.

Process and analytical method transfer

Siegfried plans and designs processes from an early development phase, ensuring a successful scale-up and transfer to commercial production. Our equipment is consistent in different scales and sizes, enabling easy process transfer and scale-up from lab scale to commercial production. Siegfried supports the complete process transfer of your product, either to our own sites or to a location of your choice. Services include:

  • Transfer of analytical methods, including cleaning validation
  • Transfer and/or scale-up of the production process
  • Process qualification and validation
  • Manufacture and release of registration batches and clinical trial material (CTM)
  • Packaging according to customer specifications
  • Stability testing according to ICH
  • Support in registration activities
  • Life cycle management

Commercial manufacturing and packaging

Siegfried is an expert in many solid drug delivery systems including:

  • Granules and powder mixtures
  • Pellets and mini-tablets
  • Film-coated tablets and pellets
  • Hard capsules
  • Tablets and capsules containing highly potent APIs
  • Inhalation capsules

Siegfried supplies oral solid drug products packaged and ready to market worldwide in accordance with all cGMP, customer and market-specific requirements:

  • Primary packaging for formulations with standard APIs and highly potent APIs
    • HDPE bottles
    • Thermo and cold-form blisters, including on-line blister printing and anonymous blister, peel-off blister
  • Secondary packaging
    • Serialized bottle labeling
    • Tamper evident serialized folding boxes (automated addition of devices available)
    • Blister printing (white stock)
    • Wallet packaging
  • Tertiary packaging
    • Bundling and aggregation
    • Shipper case packaging and pallet aggregation

Technical capabilities

From small scale development and CTM scale to large scale, equipment to handle standard and highly potent APIs, Siegfried offers a variety of technology platforms:

  • Blending
  • Wet and dry granulation
  • Pellet extrusion and spheronization (currently development capabilities only)
  • Fluid bed processes (top and bottom spray)
  • Tablet compression (including minitablets, three layer tablets)
  • Coating (pan coating and Wurster coating)
  • Hard capsule filling (gelatin / HPMC)
  • Packaging in blisters and bottles and commissioning in ready-to-market configurations including serialization and aggregation for global supply

Siegfried is equipped with well-known and renowned brands like IMA, Korsch, Fette, Glatt, Diosna and Uhlmann.

Facilities

Cool storage capabilities (2 – 8°C) are available to meet the requirements of your products. All facilities are routinely inspected and qualified by national and international authorities. National approvals for handling of controlled substances are available.

Our competency centers

Explore our two oral solids competency centers located in Barberà del Vallès and Hal Far.
Explore our two oral solids competency centers located in Barberà del Vallès and Hal Far.
Drug Substance
Drug Products

Europe

Zofingen

Zofingen

Switzerland

Zofingen is the headquarters of the Siegfried Group. The production site specializes in the development and commercial manufacturing of active pharmaceutical ingredients (APIs) and intermediates, including high potency APIs. Founded in 1873, the site has a broad portfolio of technological capabilities including hydrogenation, organometallic and hydride chemistry, halogenation, methylation, milling and micronization and more. Its production and development processes adhere to the highest quality standards, including Good Manufacturing Practices (GMP), and dedication to safety, health protection and environmental responsibility.

Competencies

  • Active pharmaceutical ingredients (API) and intermediates
  • Highly active and controlled substances
  • Custom synthesis
Founded in: 1873
Employees: 696
Head Office Siegfried AG
Untere Bruehlstrasse 4
4800 Zofingen Switzerland
Evionnaz

Evionnaz

Switzerland

Siegfried Evionnaz specializes in custom synthesis of active ingredients and intermediates for the pharmaceutical industry. Established in 1957, the site has a broad portfolio of technologies including micronization, azide chemistry, hydrogenation, halogenation, organometallics, cryogenics, and more. Focused on niche technologies, the facility possesses development capacity from 1 gram to industrial-scale production, with all activities in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.

Competencies

  • Active pharmaceutical ingredients (API) and intermediates
  • Custom synthesis
With Siegfried since: 2015
Employees: 366
Siegfried Evionnaz SA
Route du Simplon 1,36
1902 Evionnaz
Switzerland
Zurich

Zurich

Switzerland

DINAMIQS, a Siegfried company, is a science-driven Contract Development and Manufacturing Organization offering end-to-end viral vector manufacturing solutions to accelerate gene therapy projects from DNA design to commercial scale. DINAMIQS offers a comprehensive and customized range of manufacturing services, process development, quality control and analytics solutions for genetic medicine companies.

Competencies

  • Viral vectors
With Siegfried since: 2023
Siegfried DINAMIQS
Wagistrasse 25
8952 Schlieren
Switzerland
Hameln

Hameln

Germany

Siegfried Hameln is a leading manufacturer of parenteral solutions, producing a wide range of aseptic and terminally sterilized products in ampoules and vials for pharmaceutical companies, with a dedicated development center for sterile injectables. Its specialization lies in the production of complex formulations, including anesthetics, flammable substances, oxygen-sensitive liquids, and cold chain products, all while ensuring strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards. The site has a broad portfolio of technological capabilities including cold-chain handling, automated visual inspection and packing and more.

Competencies

  • Sterile and aseptic filling of ampoules and vials
  • Biologics and small molecules
With Siegfried since: 2014
Employees: 503
Siegfried Hameln GmbH
Langes Feld 13
31789 Hameln
Germany
Minden

Minden

Germany

Siegfried Minden specializes in synthesis of active ingredients and intermediates for the pharmaceutical industry. Established in 1935 and focused on efficient operations and special technologies, the facility possesses production capacity from approximately 25 kilograms to multi-100-ton-scale production. The site has a broad portfolio of technological capabilities such as hydrogenation, organometallic and hydride chemistry, milling and micronization, halogenation and more. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.

Competencies

  • Active pharmaceutical ingredients (API) and intermediates
  • Highly active and controlled substances
  • Custom synthesis

Nachbarschaftsbroschüre

With Siegfried since: 2015
Employees: 445
Siegfried PharmaChemikalien
Minden GmbH
Karlstrasse 15
32423 Minden
Germany
St.Vulbas

St.Vulbas

France

Siegfried St. Vulbas specializes in synthesis of active ingredients, intermediates and custom synthesis for the pharmaceutical industry. Established in 1993, the site has a broad portfolio of technological capabilities such as organometallic and hydride chemistry, phosgenation, hydrogenation, halogenation and more. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.

Competencies

  • Active pharmaceutical ingredients (API) and intermediates
  • Custom synthesis
With Siegfried since: 2015
Employees: 145
Siegfried St. Vulbas SAS
Parc Industriel de la Plaine de l‘Ain
530 Allée de la Luye
01150 Saint Vulbas
France
Hal Far

Hal Far

Malta

Siegfried Malta specializes in the manufacturing of oral solid dosage forms (OSD), encompassing tablet and capsule formulations with diverse release profiles (IR, SR, DR), formulations and technologies. Established in 2007 as one of the first OSD sites within the Siegfried network, technologies range from dry blends, aqueous and organic – wet/dry granulation (bottom with Wurster technology and top spray), tableting, encapsulation, coating and blister packaging. The facility has the ability to produce manufacturing batch sizes on a mid – large scale, with a focus on tech transfer and scale up activities. All operations comply strictly with quality standards (GxPs), safety, health protection and environmental standards.

Competencies

  • Bulk manufacturing and packaging of solid dosage forms for oral applications
With Siegfried since: 2007
Employees: 151
Siegfried Malta Ltd
HHF070 Hal Far Industrial Estate
Hal Far BBG 3000
Malta
Barberà del Vallès

Barberà del Vallès

Spain

Siegfried Barberà specializes in manufacturing and packaging solid oral dosage forms (OSD), including high-potency and inhalation capsules for treating respiratory diseases. Established in 1994, the site supplies products worldwide including Japan and the USA. The site has a wide range of equipment to produce solid formulations on a small and large scale, with blister, bottle and wallet/Shellpak packaging forms. Our state-of-the-art production equipment integrates Industry 4.0 technologies, such as digitization, system integration, robotics, and automation, ensuring precise processes that meet quality, safety, and environmental standards. A new Development Center was established in 2021 with facilities in Barberà and El Masnou. The center in Barberà offers development and scale-up services for solid dosage forms and inhalation capules.

Competencies

  • Bulk manufacturing and packaging of solid dosage forms for oral applications including high potency
  • Inhalation capsules for medical devices to treat respiratory diseases

Watch the site video

With Siegfried since: 2021
Employees: 490
Siegfried Barbera S.L.
Ronda de Santa Maria 158
08210 Barberà del Vallès (Barcelona)
Spain
El Masnou

El Masnou

Spain

Siegfried El Masnou has a long track record of expertise in manufacturing aseptic products, with the site established in 1925. It is the largest factory in Spain specialized in ophthalmic products, both eye drops and sterile eye care ointments, as well as products for nasal and otic use. The site’s technological capabilities include ball milling molturation, pre-use post sterilization integrity testing, and multi-dose round, oval and preservative-free bottles. Processes are fully automated and use cutting-edge technology, embracing Industry 4.0 technologies like system integration, robotics, and extensive automation. Facilities, equipment, and environmental conditions adhere to the strictest manufacturing standards. A new Development Center was established in 2021 with facilities in El Masnou and Barberà. The center in El Masnou offers development and scale up services focused on sterile ophthalmic products.

Competencies

  • Bulk manufacturing and packaging of sterile ophthalmic products, including eye drops, eye ointments, otic/nasal sprays

Watch the site video

With Siegfried since: 2021
Employees: 394
Siegfried El Masnou, S.A.
Camil Fabra, 58
08320 El Masnou (Barcelona)
Spain

USA

Pennsville

Pennsville

New Jersey

Pennsville is Siegfried’s drug substance manufacturing site for the US market and provides spray drying operations globally. Established in 1928, its main activities are pilot and commercial manufacturing of drug substances (APIs) and intermediates, in a fully cGMP and SHE compliant manner. The site has a broad portfolio of technological capabilities including spray drying, organometallic and hydride chemistry, hydrogenation, milling and micronization and more.

Competencies

  • Active pharmaceutical ingredients (API) and intermediates
  • Highly active and controlled substances
  • Custom synthesis
With Siegfried since: 1928
Employees: 181
Siegfried USA, LLC
33 Industrial Park Road
Pennsville, NJ 08070
USA
Irvine

Irvine

California

Siegfried Irvine is a sterile drug product manufacturing site, specializing in innovative and difficult to manufacture pharmaceuticals, ophthalmics, and drug delivery devices. It provides cGMP sterile drug product fill and finish of biologics, suspensions, emulsions, ointments, and gels in a fully compliant manner. Established in 2002, the site’s technological capabilities include state-of-the-art filling lines for vials, droptainers and prefilled syringes; bulk filling capabilities; and low oxygen, light sensitivity, low humidity and non-aqueous product handling.

Competencies

  • Sterile and aseptic filling of large and small molecules
With Siegfried since: 2012
Employees: 146
Siegfried Irvine
9342 Jeronimo Road
Irvine, CA 92618
USA

Asia

Nantong

Nantong

China

Siegfried Nantong specializes in custom synthesis of active ingredients and intermediates for the pharmaceutical industry. Established in 2012, the chemical plant’s technological capabilities include organometallic chemistry, hydrogenation, alkylation, amination, chlorination and milling. The facilities offer services from process development, scale-up to industrial production, in full compliance with GMPs and with safety, health protection and environmental standards.

Competencies

  • Active pharmaceutical ingredients (API) and intermediates
  • Custom synthesis
With Siegfried since: 2013
Employees: 270
Siegfried (Nantong) Pharmaceuticals Co. Ltd.
No. 5, Tongshun Road, NETDA
Nantong City, Jiangsu Province
P.R.C. (post code: 226017)

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