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Drug Substances

API manufacturing from early development to commercial

At Siegfried, we unite scientific expertise with a global manufacturing network to deliver reliable, high-quality APIs from early development to commercial scale.

Extensive experience in process development and API manufacturing

With deep scientific expertise in process development and scale-up, we help customers accelerate development timelines and maximize operational efficiency. As one of the industry’s trusted active pharmaceutical ingredient manufacturers, our global manufacturing network, combined with extensive experience in drug substance and pharma API manufacturing, ensures reliable API supply for pharmaceutical companies of all sizes: from clinical phases through full commercial production.

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Ensuring a reliable supply of drug substances with our CDMO services

With our cutting-edge global network, we ensure a reliable supply of drug substances for our customers and continuity of treatment for millions of patients worldwide. From early phase development to commercial production, we bring expertise to every phase.

A global API manufacturing network to ensure security of supply

Our global network ensures reliable supply for our customers and continuity of treatment for millions of patients worldwide. With 13 sites across three continents, we deliver robust, on-time manufacturing close to local markets, offer dual-sourcing options for added security, and rapidly adapt to shifts in demand or peak capacity requirements – strengths that distinguish us among leading active pharma ingredients manufacturers.

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Seamless tech transfers to accelerate your speed to market

As an experienced API CDMO, we ensure smooth technology transfers from early process development through commercial manufacturing. Our matrix organization enables smooth coordination between teams, minimizing delays and maintaining consistent quality.

We deliver efficient transfers through:

  • cross-functional alignment between development and production
  • harmonized documentation and QA systems across sites
  • strong technical foundation in complex API process development
  • flexible onboarding tailored to your timeline and scale

Impeccable quality track record over multiple decades

At Siegfried, quality is a proven strength. All of our sites operate under strict cGMP API manufacturing standards and our harmonized quality system has passed 1,000+ customer audits and 100+ inspections worldwide. With certifications to supply 180+ countries and consistent documentation across all sites, we enable seamless transfers and simple document access for customers.

Sustainable API manufacturing through smart process design

Scaling from grams to tons, our API manufacturing approach delivers quality, optimized yield and end-to-end regulatory alignment. From early-phase synthesis to commercial supply, we unite deep scientific expertise with operational excellence to deliver on time and in full. Our approach is tailored to fit your product, timeline, and goals.

We help you grow with confidence through:

  • consistent quality at every volume
  • adaptability to meet evolving needs
  • proven process control from start to finish

With decades of experience in drug substance manufacturing, we’re ready to deliver.

API manufacturing at Siegfried: Scientific expertise from molecule to market

No matter at which stage of the development phase you are, we are here to guide through our expertise. As your API CDMO, we take your program from pre-clinical development through commercial launch and beyond. If you’re looking to build from existing assets, our API catalog offers a range of established active ingredients available for licensing and supply.

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Our competency centers

With facilities in Zofingen, St. Vulbas, Minden, Nantong, and Grafton, we offer proximity to key markets and adaptable supply capabilities. Each competency center combines scientific know-how, advanced technologies, and custom API manufacturing – for a shared focus on quality, safety, and reliability.
With facilities in Zofingen, St. Vulbas, Minden, Nantong, and Grafton, we offer proximity to key markets and adaptable supply capabilities. Each competency center combines scientific know-how, advanced technologies, and custom API manufacturing – for a shared focus on quality, safety, and reliability.
Drug Substance
Drug Products

Europe

Barberà del Vallès

Barberà del Vallès

Spain

Siegfried Barberà is one of Siegfried’s six Drug Products sites globally. It 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. It has a dedicated Development Center offering development and scale-up services for solid dosage forms and inhalation capules. 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. Its state-of-the-art production equipment integrates Industry 4.0 technologies, such as digitization, system integration, robotics, and automation, ensuring precise processes. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.

Competencies

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

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With Siegfried since: 2021
Employees: 483
Siegfried Barbera S.L.
Ronda de Santa Maria 158
08210 Barberà del Vallès (Barcelona)
Spain
El Masnou

El Masnou

Spain

Siegfried El Masnou is one of Siegfried’s six Drug Products sites globally. It 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. It has a dedicated Development Center offering development and scale up services focused on sterile ophthalmic products. 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. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.

Competencies

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

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Watch the development center video

With Siegfried since: 2021
Employees: 497
Siegfried El Masnou, S.A.
Camil Fabra, 58
08320 El Masnou (Barcelona)
Spain
Evionnaz

Evionnaz

Switzerland

Siegfried Evionnaz is one of Siegfried’s two launch sites for newly developed processes. It specializes in custom synthesis of active ingredients and intermediates for the pharmaceutical industry. With an R&D Center housing advanced chemical and analytical facilities, state-of-the-art laboratories, and cutting-edge technologies, it offers chemical process R&D and analytical development services for Siegfried’s global Drug Substances network. 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. 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: 408
Siegfried Evionnaz SA
Route du Simplon 1,36
1902 Evionnaz
Switzerland
Hal Far

Hal Far

Malta

Siegfried Malta is one of six Siegfried’s Drug Products sites globally. It 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: 173
Siegfried Malta Ltd
HHF070 Hal Far Industrial Estate
Hal Far BBG 3000
Malta
Hameln

Hameln

Germany

Siegfried Hameln is one of Siegfried’s six Drug Products sites globally. It is a leading manufacturer of parenteral solutions, producing a wide range of aseptic and terminally sterilized products in ampoules and vials, 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. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.

Competencies

  • Sterile and aseptic filling of ampoules and vials
  • Biologics and small molecules
With Siegfried since: 2014
Employees: 579
Siegfried Hameln GmbH
Langes Feld 13
31789 Hameln
Germany
Minden

Minden

Germany

Siegfried Minden is one of our Siegfried’s four run and deliver sites for established processes. It 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: 529
Siegfried PharmaChemikalien
Minden GmbH
Karlstrasse 15
32423 Minden
Germany
St.Vulbas

St.Vulbas

France

Siegfried St.Vulbas is one of Siegfried’s four run and deliver sites for established processes. It 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: 176
Siegfried St. Vulbas SAS
Parc Industriel de la Plaine de l‘Ain
530 Allée de la Luye
01150 Saint Vulbas
France
Zofingen

Zofingen

Switzerland

Zofingen is the headquarters of the Siegfried Group and one of Siegfried’s two launch sites for newly developed processes. 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. 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
Founded in: 1873
Employees: 750
Head Office Siegfried AG
Untere Bruehlstrasse 4
4800 Zofingen 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
Employees: 26
Siegfried DINAMIQS
Wagistrasse 18
8952 Schlieren
Switzerland

USA

Irvine

Irvine

California

Siegfried Irvine is one of Siegfried’s six Drug Product sites globally. It 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. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.

Competencies

  • Sterile and aseptic filling of large and small molecules
With Siegfried since: 2012
Employees: 185
Siegfried Irvine
9342 Jeronimo Road
Irvine, CA 92618
USA
Grafton

Grafton

Wisconsin

The Siegfried Acceleration Hub in Grafton specializes in early-phase development and manufacturing. Established in 1998, the site offers phase-appropriate analytical and development services, regulatory expertise, and regulatory-compliant quality systems — all with the capability to manage highly potent and controlled substances. The Acceleration Hub provides end-to-end life cycle management with services from preclinical through commercial, including scale-up, tech transfer, validation and launch, with seamless transfer into Siegfried’s global network. The site has a broad portfolio of technologies and capabilities, including phase-appropriate preclinical process development, advanced filtration technologies, CMC sections of DMFs, alternate synthesis, route scouting and more. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.

Competencies

  • Early-phase development and manufacturing

 
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With Siegfried since: 2024
Employees: 85
870 Badger Circle
Grafton, WI 53024
USA
Pennsville

Pennsville

New Jersey

Siegfried Pennsville is one of Siegfried’s four run and deliver sites for established processes. It 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: 183
Siegfried USA, LLC
33 Industrial Park Road
Pennsville, NJ 08070
USA

Asia

Nantong

Nantong

China

Siegfried Nantong is one of Siegfried’s four run and deliver sites for established processes. It specializes in custom synthesis of active ingredients and intermediates for the pharmaceutical industry. Established in 2013, the chemical plant’s technological capabilities include organometallic chemistry, hydrogenation, alkylation, amination, chlorination and milling. 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: 2013
Employees: 258
Siegfried (Nantong) Pharmaceuticals Co. Ltd.
No. 5, Tongshun Road, NETDA
Nantong City, Jiangsu Province
P.R.C. (post code: 226017)

FAQ: API manufacturing

What is the difference between API development and API manufacturing?

API development focuses on designing and optimizing chemical processes to produce a drug substance efficiently, safely, and at the right quality. API manufacturing applies these processes at commercial scale under strict regulatory standards. At Siegfried, both are seamlessly connected –ensuring a smooth transition from laboratory innovation to full-scale production.

At which stages of drug development does Siegfried provide support?

Siegfried supports pharmaceutical companies from early-stage development through commercial production and lifecycle management. Our teams assist with route scouting, process optimization, scale-up, and regulatory alignment – providing tailored solutions for every phase. Whether you’re preparing for clinical trials or global market launch, we grow with your project’s needs.

How does Siegfried manage technology transfer between sites?

Siegfried ensures efficient technology transfer through close coordination between development and production teams. Our harmonized documentation, standardized QA systems, and global network enable seamless process handovers. With proven expertise in complex APIs, we minimize delays and safeguard consistency – so your molecule performs reliably at every scale and location.

Can Siegfried support both clinical and commercial API production?

Yes. Siegfried offers fully integrated API development and manufacturing services from lab to market. We scale processes from grams to tons, ensuring regulatory compliance and consistent quality at every stage. Our flexible network allows smooth progression from clinical supply to commercial manufacturing without compromising timelines or product integrity.

How does Siegfried ensure consistent quality across global API manufacturing sites?

All Siegfried sites operate under strict cGMP standards and are regularly inspected by global health authorities. Harmonized quality systems, unified documentation, and cross-site collaboration ensure reproducible performance. Through continuous training and global alignment, we maintain the same high standards of safety, quality, and reliability worldwide.

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