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Exclusive synthesis

We are experts in process development and manufacturing of exclusive active pharmaceutical ingredients and intermediates.
We are experts in process development and manufacturing of exclusive active pharmaceutical ingredients and intermediates.

Your most trusted partner for exclusive synthesis

Expertise

150 years experience in process development and production of customized APIs

Reliability

Secure and reliable supply through close collaboration with key partners along the value chain

Quality

Outstanding quality and regulatory track record

Our wide range of services for exclusive synthesis

Process and chemical development

Siegfried’s drug substance process and chemical development services assist you in achieving genuinely scalable, cost-effective and robust pharmaceutical manufacturing appropriate to your product’s market needs.

Our innovative scientists are well experienced in the development of entirely new synthetic routes or adapting and optimizing existing processes. Siegfried will work closely with you to understand your needs, establishing the development objectives and scope for process optimization.

Analytical development

Our well-experienced drug substance analytical development team works closely with the process development department to ensure your product is fully supported at every phase of the development process. We work closely with our clients to understand your needs and establish analytical objectives and development scope, with the shared goal to develop routine procedures and efficient analytical testing methods packaged together with specifications suitable for Quality Control.

With more than 500 method validations in accordance with ICH Guidelines and vast experience in cGMP compliance, we can support and advise our customers on relevant analytical aspects in the pharmaceutical sector including purity profiles, impurity tracking, establishing limits, structure determination, genotoxic contamination, and heavy metal determinations.

Pilot manufacturing and scale up

With experience and knowledge from more than 1,600 chemical development projects, we take chemical processes from development and scale them up into cost-effective and robust manufacturing processes. We support your various needs from early clinical trials through to commercial launch and routine manufacturing.

Our versatile cGMP pilot manufacturing and scale-up capabilities at our production sites in Zofingen, Evionnaz, Nantong, and Pennsville accelerate your drug development.

Manufacturing

As your flexible partner, Siegfried provides reliable and consistent commercial supply of high-quality products. We achieve this by providing our customers with versatile cGMP manufacturing capabilities and robust processes tailored to their specific market requirements.

Leveraging our extensive experience in manufacturing APIs, key intermediates for exclusive customers, and a portfolio of generic products, we provide a wide array of chemistries and production capabilities at scale. This enables efficient manufacturing of demanding drug substances, intermediates, and complex synthetic processes, including controlled substances and high-potency materials.

Technical capabilities

Siegfried’s state-of-the-art labs and production facilities are designed to facilitate a wide range of organic chemical reactions and enzyme-catalyzed transformations. Reaction conditions range from -100°C to 300°C and from 1 mbar to 40 bar.

Using lab automation and associated analytical tools we generate process data and information in the most effective way, speeding up development lead times and gaining greater understanding of reaction parameters. We conduct synthesis and analysis of high potency materials (with OEL down to 1 µg/m3) in specifically-built, segregated laboratory areas.

Siegfried pays special attention to crystallization and product isolation processes, as these are vital for product yield and purity. Manufacturing processes for clearly defined crystal modifications and particle size distribution are developed – aided by various analytical techniques – and complemented by milling processes. Further techniques to manipulate physical form include spray drying, micronization and pre-formulation mixtures.

Scaling up chemical processes is crucial. In process development, we establish a safe, quality-driven, economical, sustainable, and robust foundation. Our approach involves scale-down principles and a ‘Siegfried Toolbox’—defined lab experiments, analytical tools, and computerized models. We are committed to enhancing process performance, and are part of the Miniplant 4.0 Association, focused on innovative technologies for mimicking production scale in the chemical process laboratory.

Our process and chemical development capabilities are fully supported by an array of analytical techniques and equipment, such as NMR, HPLC, UPLC, GC, LCMS, GCMS, DSC/TGA, DVS and Malvern  and Helos PSD equipment.

Our analytical data, standards, specifications and testing guidelines are managed using a validated LIMS system. Analytical instruments include:

  • HPLC, UPLC, GC (controlled via a CDS central server)
  • LC-MS, GC-MS, ICP-MS, NMR, IC, DSC, particle sizes, AAS, UV, IR, NIR, Raman and wet-chemical standard methods for the release of raw materials, intermediate products and APIs.

Our competency centers

Explore our drug substance competency centers located in Zofingen, Evionnaz, St. Vulbas, Minden, Pennsville and Nantong.
Explore our drug substance competency centers located in Zofingen, Evionnaz, St. Vulbas, Minden, Pennsville and Nantong.
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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