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Ophthalmics

Siegfried is your expert in ophthalmic formulations with outstanding manufacturing and packaging capabilities.
Siegfried is your expert in ophthalmic formulations with outstanding manufacturing and packaging capabilities.

Your most trusted partner for ophthalmics

Expertise

Dedicated Development Center offering development and scale up services

Reliability

95+ years experience as a reliable ophthalmic partner

Agility

Providing tailored solutions for complex formulations and processes

Our wide range of services for ophthalmics

Pharmaceutical development

Our flexible platform offers the development of standard and complex ophthalmic formulations. Siegfried’s development experts support you with:

  • Evaluating primary packaging materials
  • Selecting the right sterilization system (filtration, steam sterilization, dry heat, chemical sterilants or gamma irradiation)
  • Identifying the best mixing and dosing system (e.g. peristaltic or rotary piston pumps)
  • Studying production material and packaging interactions with your formulation and supporting leachables and extractables studies
  • Evaluating terminal sterilization effects

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. A qualified person approves all GMP relevant documents and makes the market release.

Siegfried offers drug product clinical trial manufacturing under cGMP conditions at our Irvine and El Masnou facilities, serving all the countries where your clinical study is carried out utilizing fixed or disposable technologies.

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 adaptable and scalable solutions cater to a wide range of formulation and project needs, encompassing both ANDA and NDA products. We offer specialized knowledge in equipment and process design to support your project seamlessly throughout every stage of manufacturing. Siegfried supports complete process transfer of your product to our US or EU locations. 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
  • Packaging according to customer specifications
  • Stability testing according to ICH
  • Support in registration activities
  • Life cycle management

Commercial manufacturing and packaging

Siegfried supplies ophthalmics packed and ready to market worldwide in accordance with all cGMP, customer and market-specific requirements:

  • Primary packaging
    • Bottles (round, oval, glass BTC)
    • Tubes (alu, laminated foil)
    • Preservative-free bottles (Aptar®)
  • Secondary packaging
    • Labeling of bottles
    • Tamper evident serialized folding boxes
    • Pouch packaging
  • Tertiary packaging
    • Bundling and aggregation
    • Shipper and pallet aggregation

Technical capabilities

Our technical capabilities cover:

  • Compounding of sterile ointments, gels, suspensions and solutions
  • Filling in tubes and bottles (bottle/ tip/ cap)
  • Manufacturing and filling of preservative free forms in multi-dose bottles (using Aptar® OSD-opthalmic squeeze dispenser)
  • Final packaging in ready-to-market configurations including serialization and aggregation
  • In-house technical expertise and state of the art microbiology and chemistry laboratories for both incoming raw materials, in-process and finished product testing capability services

Siegfried is equipped with well-known and renowned brands like Waldner, Fryma, IWK, Bausch + Ströbel and Uhlmann.

Facilities

All facilities are routinely inspected by national and international authorities.

Competency centers

Explore our two competency centers for ophthalmic formulations located in Irvine and El Masnou.
Explore our two competency centers for ophthalmic formulations located in Irvine and El Masnou.
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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