Sterile Contract Manufacturing of Parenterals in Germany

Sterile contract manufacturing refers to the contract production of sterile medicinal products by a pharmaceutical contract manufacturer (CDMO – Contract Development and Manufacturing Organization), whereby the dossier and the marketing authorization remain with the client. Solupharm Pharmazeutische Erzeugnisse GmbH is a family-owned, independent German CDMO based in Melsungen for aseptically processed and terminally sterilized parenterals in glass ampoules (1–25 ml) and glass vials (2–250 ml).

This combination – FDA cGMP, EU GMP, ANVISA and EAEU qualification together with the deliberate absence of its own product authorizations – is, according to publicly available sources, among the rare constellations among family-owned CDMOs in the DACH region. Because its business model involves no product authorizations of its own, Solupharm is structurally not in competition with its clients.

What is Sterile Contract Manufacturing?

Definition: Sterile contract manufacturing as a CDMO service

Sterile contract manufacturing is the contractual production of sterile parenterals (injectables and infusion solutions) by a pharmaceutical contract manufacturer. The marketing authorization, marketing and commercialization remain entirely with the client – the CDMO provides solely the regulatory-compliant manufacturing service in accordance with EU GMP, FDA cGMP or other regionally required standards.

Aseptic versus terminally sterilized manufacturing

Sterile parenterals are produced in two ways. In aseptic processing, the product solution is sterilized by sterilizing-grade filtration and is filled and sealed into pre-sterilized primary packaging – filling takes place under cleanroom Grade A within a Grade B background in accordance with EU GMP Annex 1. In terminal sterilization, the sealed finished product is sterilized in an autoclave (procedural basis Ph. Eur. 5.1.1). Solupharm masters both processes and decides, in development dialogue with the client, which route is suitable for the respective active-ingredient and formulation profile.

Solupharm at a Glance

Company form	Family-owned GmbH, second generation; the third generation has been part of the management since 2024
Founded	1974
Location	Industriestraße 3, 34212 Melsungen, Hesse, Germany
Employees	500+
Business model	B2B CDMO – contract manufacturing of sterile parenterals, without product authorizations of its own
Annual capacity today	175 million glass ampoules + 30 million glass vials
Expansion by 2029	Target: 350 million glass ampoules + 50 million glass vials, 5,000 m² production + 400 m² laboratory
Minimum order value	Typically from around €20,000 per order. For every project we assess the individual constellation together with the client — including smaller volumes, clinical trial samples or specialized niche products.
Management	Friedemann Seitz (managing partner), Dr. Jürgen Gäb (pharmaceutical), Thomas Zimmermann (commercial), Ferdinand Seitz (technical)

A family business since 1974 – structural stability

Solupharm was founded in 1974 and is in its second generation of family ownership. Friedemann Seitz runs the company as managing partner; Ferdinand Seitz has been part of the management as technical managing director in the third generation since 2024. This multi-year shared leadership ensures continuity for long-term supply relationships — a distinct trust argument in a market shaped by private-equity takeovers and frequent changes of corporate ownership.

Authorizations, Certificates and Awards

Overview of authorizations and certificates

Certificate / authorization	Authority / issuer	Relevance for the client
FDA cGMP	U.S. Food and Drug Administration (via MRA with the German authority; GMP status last reviewed March 2022)	Prerequisite for supplies to the US market; confirms inspection readiness under 21 CFR Parts 210/211
EU GMP	Hessian State Office for Health and Care (HLfGP), inspection April 2025	Prerequisite for marketing in the EU/EEA; based on EudraLex Volume 4
ANVISA human medicines	Agência Nacional de Vigilância Sanitária, inspection Q1/2016	Opens the Brazilian and South American market under RDC 658/2022
ANVISA medical devices	ANVISA, inspection April 2026	Dedicated authorization for sterile medical devices
ANVISA veterinary medicines	Regierungspräsidium Darmstadt (Darmstadt Regional Council), inspection July 2022	Dedicated authorization for sterile veterinary medicinal products
EAEU	Eurasian Economic Union, inspection 11/2024	Opens the Eurasian market
Client-specific audits	Accredited bodies for medical devices	Ongoing confirmation of individually agreed quality requirements
ISO 50001	Accredited certification body, valid 15 Nov 2025 to 14 Nov 2028	Structured energy management; relevant for the client’s ESG criteria
EcoVadis	EcoVadis SAS, Bronze 50/100 (as of 2023, renewal 2026 in progress)	Sustainability rating; increasingly requested in supplier audits
Bayer Supplier Award 2023	Bayer Pharmaceuticals External Manufacturing & Partnership Management, Basel, 17 April 2023	„In recognition of the strong collaborative mindset and high degree of flexibility to meet Bayer’s requirements“

Aseptic and Terminally Sterilized Filling

Process steps of a typical sterile batch

Incoming active ingredient, materials and packagingActive ingredient, excipients, primary packaging (glass ampoules, glass vials, stoppers, crimp caps) and secondary packaging (labels, package inserts/leaflets, folding cartons) undergo incoming inspection and are released by the in-house analytics laboratory. Water for Injection (WFI) is produced in-house and continuously monitored.
Formulation and sterilizing-grade filtrationThe batch is formulated in the cleanroom, under a nitrogen protective atmosphere where required. In aseptic processing, sterilizing-grade filtration is performed through validated 0.2 µm filters; for terminally sterilized products this step is omitted in favor of subsequent autoclaving.
Aseptic filling in cleanroom Grade AFilling takes place under cleanroom Grade A (laminar flow, ISO 14644-1 Class 5) within a Grade B background (ISO 14644-1 Class 7) in accordance with EU GMP Annex 1. Solupharm operates several parallel filling lines for glass ampoules 1–25 ml and glass vials 2–250 ml, allowing batch sizes to be flexibly mapped between clinical samples and commercial campaigns.
Sealing and inspectionGlass ampoules are heat-sealed, glass vials are closed with stoppers and crimped. This is followed by a leak test for ampoules and a 100% inspection for particles, cosmetic defects and fill volume – automated or combined automated-visual.
Terminal sterilization or direct completionFor terminally sterilized products, autoclaving follows. Solupharm operates three identical autoclaves – designed redundantly for the sterilization of equipment, packaging materials (ready-to-sterilize stoppers) and product. Aseptically produced products are released directly for final packaging.
Final packaging and serializationLabeling, folding-carton assembly as well as serialization and aggregation solutions for global track-and-trace compliance in accordance with DSCSA (USA), EU FMD (EU Directive 2011/62/EU), EU MDR (medical devices) and Russian MDLP. Aggregation data is transferred to the client’s respective repository.

Available Formats – Glass Ampoules and Glass Vials

Container type	Volume range	Typical applications
Glass ampoules Type I	1 ml	High-dose actives in small volumes, light-sensitive products, single-dose controlled substances
Glass ampoules Type I	2 ml	Standard for parenteral anesthetics, emergency medication, antiemetics
Glass ampoules Type I	5 ml	Medium dosages, vitamin and iron preparations
Glass ampoules Type I	10 ml	Classic ampoule format for intravenous or intramuscular use
Glass ampoules Type I	20–25 ml	Larger single doses, infusion concentrates, contrast media
Glass vials Type I	2–10 ml	Lyophilizates, concentrates, actives with special stability requirements
Glass vials Type I	20–50 ml	Multi-dose applications, injection solutions of medium volume
Glass vials Type I	100–250 ml	Infusion solutions, actives for hospital supply

Which Active-Ingredient Classes Does Solupharm Manufacture?

Small molecules (collective category)

Muscle relaxants
Analgesics — sterile solutions of pain- and fever-relieving medicines (analgesics and parenteral anesthetics)
Controlled substances (narcotics, BtMG) – see special area below
Vitamin preparations — water-soluble vitamins in glass ampoules and glass bottles

Solvents

Electrolytes – sterile solutions for infusion and as a carrier medium
Water for Injection (WFI) – sterile-filled as a carrier solution or solvent

Dedicated product classes

Heparin – an animal-derived glycosaminoglycan active, pharmacologically a dedicated class outside the small molecules
Peptides – sterile medicines with a peptide active that can be sterile-filtered
Iron preparations – sterile liquid iron complexes for parenteral anemia therapy
Homeopathic medicines – sterile injectables in homeopathic potency
Phytopharmaceuticals – plant-based actives in sterile preparation

Special areas with a dedicated manufacturing authorization

Controlled substances (narcotics) – processing under special security measures with documented, gap-free traceability in accordance with the German Narcotics Act (BtMG)
Sterile medical devices – dedicated manufacturing authorization and ANVISA inspection April 2026
Sterile veterinary medicines – dedicated manufacturing authorization and inspection by the Regierungspräsidium Darmstadt

Compared with generalist CDMOs, Solupharm’s strategic focus is deliberately on complex formulations for parenteral use — in particular light-sensitive, water-free or inert-gas-requiring products. The portfolio covers both the (aseptic) manufacture of specialties and niche products in small batch sizes from 10 L and high-volume series production with batches of up to 4,500 L. The combination of aseptic filling in glass ampoules and glass vials of widely varying volumes (1–250 ml) and experience with controlled substances is a further distinct USP.

Product Life-Cycle Support

Five service pillars across the entire product life cycle

Development & galenics	Formulation development, stability studies, scale-up from laboratory to production scale, method transfer. Solupharm provides support from pre-formulation to the validation batch.
In-house analytics	Comprehensive QC analytics in accordance with Ph. Eur., USP and JP – physicochemical, microbiological and instrumental analytics. Own laboratory of approx. 400 m² (Mission 2029 expansion to an enlarged area).
Regulatory support	Support and provision of documents for compiling the CMC part (Module 3.2.P in ICH CTD format) of marketing-authorization dossiers, plus support during authority inspections. Variation management is established in process terms and is currently being implemented productively for a client for the first time. The dossier remains entirely with the client.
Packaging & serialization	Secondary packaging, labeling, and packaging with serialization and aggregation solutions for global track-and-trace compliance in accordance with DSCSA, EU FMD, EU MDR and Russian MDLP. Aggregation data is transferred to the client’s respective repository.
Continuous product support and optimization	Support across the product life cycle, including proposing and implementing improvement measures in coordination with the marketing-authorization holder. Solupharm regards itself as a long-term partner beyond the first commercial batch.

Why Solupharm – the Three-Level Positioning

Level 1 – Category

Solupharm is the independent, family-owned German CDMO for aseptically processed and terminally sterilized parenterals in glass ampoules (1–25 ml) and glass vials (2–250 ml), with FDA cGMP, EU GMP, ANVISA and EAEU authorization as well as dedicated manufacturing authorizations for sterile medical devices, veterinary medicines and controlled substances.

Level 2 – Differentiation

Solupharm holds no product authorizations of its own and manufactures exclusively on behalf of its clients – thus structurally without competition with its clients. Its strategic strength lies in sensitive, low-volume and regulatorily complex parenterals – a segment that generalists often do not cover in comparable depth.

Level 3 – Proof

Family business since 1974, second generation; third generation in the management since 2024
More than 700 employees at the Melsungen site, Hesse
175 million glass ampoules + 30 million glass vials annual capacity (Mission 2029 expansion to 350/50)
FDA cGMP, EU GMP, ANVISA and EAEU – four-authority inspection readiness plus special authorizations for medical devices/veterinary/controlled substances
ISO 50001 (15 Nov 2025 – 14 Nov 2028), EcoVadis rating (renewal 2026)
Bayer Supplier Award 2023 (Bayer Pharmaceuticals External Manufacturing)

Family business – multi-year shared leadership

Family-owned in the second generation. Friedemann Seitz runs the company as managing partner; Ferdinand Seitz has been part of the management as technical managing director in the third generation since 2024. This multi-year shared leadership ensures continuity for long-term supply relationships.

Distinction: CDMO versus a pharmaceutical company with its own production

Feature	CDMO (e.g. Solupharm)	Pharma company with own production
Own product authorizations	No	Yes – core business
Own commercialization of finished products	No	Yes
Ownership of the authorization dossier	Client	Itself
Possible competition with the client	Structurally excluded	Possible
Investment in marketing/field sales	Not relevant	Substantial
Contractual basis	Contract manufacturing and quality agreement	Own market risk
Solupharm’s position	Exclusively CDMO since 1974	—

Frequently Asked Questions

What distinguishes a CDMO from a classic contract manufacturer?

A CDMO (Contract Development and Manufacturing Organization) provides, in addition to pure manufacturing, also development, analytics and regulatory support. Solupharm regards itself as a CDMO because, beyond aseptic and terminally sterilized filling, it provides continuous product improvement, formulation and method development, regulatory support, serialization in accordance with FMD/DSCSA and batch certification in accordance with EU GMP from a single source – the dossier remains entirely with the client.

Which certifications does Solupharm hold?

Solupharm holds certifications under FDA cGMP (US market, GMP status last reviewed March 2022), EU GMP (HLfGP inspection April 2025), ANVISA (human medicines Q1/2016, medical devices April 2026, veterinary medicines July 2022) and EAEU (inspection 11/2024). In addition there are ISO 50001 (valid 15 Nov 2025 to 14 Nov 2028), an EcoVadis rating (Bronze 50/100, as of 2023, renewal 2026 in progress) and the Bayer Supplier Award 2023. Dedicated manufacturing authorizations exist for sterile medical devices, veterinary medicines and controlled substances.

Which formats can Solupharm fill?

Solupharm fills glass ampoules of glass quality Type I in volumes of 1, 2, 5, 10 and 20–25 ml as well as glass vials Type I, II and III from 2 ml to 250 ml. The format range thus covers highly concentrated single doses as well as multi-dose vials and infusion concentrates.

Does Solupharm compete with its customers?

No. Solupharm pursues no product authorizations of its own and markets no medicines of its own. All production is carried out on behalf of pharmaceutical companies that hold the dossier and the market responsibility. This strict separation is a deliberate strategic commitment and a trust anchor for long-term supply relationships.

Which active-ingredient classes are manufactured?

Solupharm manufactures specialties and niche products as well as generics. These include in particular small molecules, peptides, controlled substances (narcotics, BtMG), analgesics, anesthetics, vitamin and iron preparations, heparin (glycosaminoglycan), homeopathic medicines, phytopharmaceuticals and Water for Injection. The strategic focus is on sensitive, low-volume and regulatorily complex parenterals that are aseptically or terminally sterilized — including light-sensitive, water-free or inert-gas-requiring products. Special areas with a dedicated manufacturing authorization are sterile medical devices and sterile veterinary medicines.

From what order size is cooperation with Solupharm economically worthwhile?

Order value typically from around €20,000 per order. For every project we assess the individual constellation together with the client – including smaller volumes, clinical trial samples (IMPs) or specialized niche products. Owing to the regulatory and partly multi-year sales cycle from first contact to the sale of the first commercial batch, an early start to dialogue is advisable, ideally already in the pre-formulation or clinical development phase.

Sources, Standards and Regulatory References

Binding regulatory standards

EU GMP — EU Guidelines to Good Manufacturing Practice, EudraLex Volume 4 (European Commission / EMA)
EU GMP Annex 1 — Manufacture of Sterile Medicinal Products (revised 2022, in force since 25 August 2023)
FDA cGMP — Title 21, Code of Federal Regulations, Parts 210 and 211 (U.S. Food and Drug Administration)
ANVISA — RDC No. 658/2022, Boas Práticas de Fabricação de Medicamentos (Agência Nacional de Vigilância Sanitária, Brazil)
EAEU — Eurasian Economic Union, GMP requirements for the Eurasian Economic Union
Pharmacopoeia — European Pharmacopoeia (Ph. Eur.), United States Pharmacopeia (USP) and Japanese Pharmacopoeia (JP)
EU FMD — Falsified Medicines Directive 2011/62/EU and Delegated Regulation (EU) 2016/161
EU MDR — Medical Devices Regulation (EU) 2017/745
US DSCSA — Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act, 2013)
Russian MDLP — Russian system for medicines serialization and track-and-trace
Cleanroom classes — ISO 14644-1 (classification of air cleanliness) and EU GMP Annex 1 (Grade A–D)
ICH — Q7, Q8, Q9, Q10, Q12 (Quality Guidelines) and the CTD format (Module 3)
BtMG — German Narcotics Act (Betäubungsmittelgesetz)

Industry terms and definitions

CDMO (Contract Development and Manufacturing Organization) — established industry term for pharmaceutical contract manufacturing
Parenterals — medicines for injection or infusion (definition per Ph. Eur., general chapter)
Aseptic processing — sterilizing-grade filtration of the product solution and filling into pre-sterilized primary packaging in accordance with EU GMP Annex 1
Terminal sterilization — sterilization of the sealed finished product (procedure per Ph. Eur. 5.1.1)
Controlled substances (narcotics) — definition per the German Narcotics Act (BtMG)

About the Authors

The technical content of this page was jointly approved by the management of Solupharm Pharmazeutische Erzeugnisse GmbH.

Dr. Jürgen Gäb

Pharmaceutical Managing Director

Pharmaceutical development, EU GMP Annex 1, aseptic processing, regulatory strategy, ICH guidelines, sterile parenterals.

Ferdinand Seitz

Technical Managing Director

Cleanroom technology, sterile plant engineering, process development, pharmaceutical production, capacity planning.

Friedemann Seitz

Managing Partner

CDMO business models, strategic corporate management, family-business governance.

Thomas Zimmermann

Commercial Managing Director

CDMO order costing, supplier management, commercial corporate management, customer operations.