Sterile contract manufacturing along three regulatory routes
This section sets out why sterile medical devices and sterile veterinary medicinal products have to be considered separately from human medicinal products — and what that means for contract givers in practice.
Key statements
1. Solupharm holds separate manufacturing authorisations for sterile medical devices and for sterile veterinary medicinal products, in addition to the authorisation for sterile human medicinal products.
2. All three product worlds are manufactured on the same production lines and in the same formats: glass ampoules of 1–25 ml and glass vials of 2–250 ml.
3. Manufacturing is inspectable under FDA cGMP, EU GMP, ANVISA and EAEU standards; for medical devices, ongoing customer-specific audits by accredited bodies are added.
4. Solupharm holds no marketing authorisations of its own and manufactures exclusively the contract giver’s product on their behalf — for medical devices and veterinary products just as for human medicinal products.
What does a separate manufacturing authorisation mean?
A manufacturing authorisation is granted per product world. Being authorised to manufacture sterile human medicinal products does not automatically permit the manufacture of sterile medical devices or veterinary medicinal products: each of these worlds has its own legal basis, its own competent authority and its own supervisory cycle.
For contract givers this is the decisive point. A CDMO holding only a medicinal products authorisation cannot have a sterile medical device placed on the market as such. Solupharm covers all three routes and can therefore handle products from different regulatory worlds through one manufacturing structure.
| Product world | Regulatory framework (EU) | Relevance for contract manufacturing |
|---|---|---|
| Sterile human medicinal products | EU GMP (Annex 1 for sterile products); Ph. Eur. | Own manufacturing authorisation as core service. Aseptic or terminally sterilised, inspectable under FDA cGMP, EU GMP, ANVISA and EAEU standards. |
| Sterile medical devices | Regulation (EU) 2017/745 (EU MDR) | Separate manufacturing authorisation. In addition, ongoing customer-specific audits by accredited bodies. |
| Sterile veterinary medicinal products | Regulation (EU) 2019/6 (Veterinary Medicinal Products Regulation); EU GMP for veterinary medicinal products under Implementing Regulation (EU) 2025/2091 | Separate manufacturing authorisation. Inspected by the Hessian State Office for Health and Care (HLfGP), most recently in June 2025. |
BUSINESS MODEL
Solupharm holds no marketing authorisations of its own and manufactures exclusively the contract giver’s product on their behalf. The dossier — the technical documentation in the case of medical devices, the marketing authorisation dossier in the case of veterinary products — remains entirely with the contract giver.
Sterile medical devices in contract manufacturing
Sterile medical devices do not act pharmacologically, yet they are introduced into the body or brought into contact with wounds and body cavities in a sterile condition. They fall not under medicinal products law but under the European Medical Device Regulation (EU) 2017/745.
Separate manufacturing authorisation
For sterile medical devices Solupharm holds a separate manufacturing authorisation; the legal basis is Regulation (EU) 2017/745 (EU MDR). It is the prerequisite for a contract giver to have a sterile medical device manufactured at Solupharm and subsequently placed on the market under their own technical documentation.
Ongoing customer-specific audits
Beyond official supervision, ongoing customer-specific audits by accredited bodies for medical devices take place. For contract givers this means the manufacturing site is audited regularly in the medical device context and not supervised under medicinal products law alone.
Labelling and traceability (UDI)
The EU MDR requires a unique device identification (UDI) for medical devices, enabling traceability across the entire supply chain. Packaging at Solupharm covers serialisation and aggregation for global track & trace compliance under DSCSA, EU FMD, EU MDR and Russian MDLP. Solupharm applies the UDI marking to the primary and secondary packaging as part of the packaging process. The assignment of the UDI and the technical documentation remain with the contract giver; the specific implementation is agreed project by project.
International supervision
For example, for the Brazilian market the medical device area falls within the ANVISA inspection cycle; the most recent medical device inspection was successfully passed in April 2026. The medical device product world is therefore covered by an authority outside the EU as well.
Sterile veterinary medicinal products in contract manufacturing
Sterile veterinary medicinal products are injectable and infusion medicines for use in animals. Since Regulation (EU) 2019/6 came into force they have been fully separated from human medicinal products in regulatory terms — with their own authorisation route and their own requirements for manufacturing and labelling.
Separate authorisation and supervision
A separate manufacturing authorisation is in place for sterile veterinary medicinal products. Official supervision is carried out by the Hessian State Office for Health and Care (HLfGP); the most recent EU GMP inspection for veterinary medicinal products took place in June 2025. The legal basis is Implementing Regulation (EU) 2025/2091 on the manufacture of veterinary medicinal products.
Why this matters for contract givers
Many contract givers run human and veterinary products in separate portfolios yet look for a single manufacturing partner. Because both authorisations are held at one site, human and veterinary products can be handled through the same quality, analytical and documentation structures — while regulatory responsibility remains separate.
How does the manufacturing process differ?
For the sterile process itself the answer is: hardly at all. Sterility is a physical and microbiological outcome and is achieved through the same validated procedures. What differs is the regulatory classification, the batch documentation, the release logic and the labelling.
1
Incoming active substances and materials
Active substances or raw materials, excipients and primary packaging materials (glass ampoules, glass vials, stoppers, flip-off caps) undergo incoming inspection and are released by the in-house analytical laboratory. Water for Injection (WFI) is produced in-house and continuously monitored.
2
Batch preparation
The batch is prepared under Grade C cleanroom conditions with laminar airflow. Batch sizes between 10 L and 4,500 L can be accommodated — from clinical or first batches through to commercial campaigns. For oxidation-sensitive formulations, processing takes place under a nitrogen blanket where required.
3
Sterile filtration or terminal sterilisation
In aseptic manufacturing the product solution is sterilised by sterile filtration (validated 0.2 µm filters) and filled into pre-sterilised primary packaging, which is then sealed. Where the formulation tolerates a final sterilisation step, the sealed finished product is heat-sterilised in the autoclave (procedural basis Ph. Eur. 5.1.1).
4
Filling under Grade A conditions
Filling takes place under Grade A cleanroom conditions (laminar airflow, ISO 14644-1 Class 5) within a Grade B environment (ISO 14644-1 Class 7) in accordance with EU GMP Annex 1 — irrespective of whether the product is a human medicinal product, a veterinary product or a medical device.
5
Sterilisation in the autoclave
Solupharm operates three identical autoclaves, configured redundantly for the sterilisation of equipment, packaging materials (ready-to-sterilize stoppers) and product. The redundancy avoids bottlenecks during maintenance or revalidation and serves all three product worlds.
6
Testing and release
100 % inspection for particles, cosmetic defects and fill volume; leak testing of the sealed containers, and for glass ampoules additionally by high-voltage leak detection (HVLD). Release follows the regulatory system applicable to the respective product world.
7
Packaging and labelling
Labelling and folding-carton packaging are carried out in-house. Packaging is equipped with serialisation and aggregation solutions for global track & trace compliance in accordance with DSCSA, EU FMD, EU MDR and Russian MDLP.
Key statement
The same sterile process, three regulatory routes. The technical difference lies not in sterility but in documentation, release and labelling — and that is precisely why the matching manufacturing authorisation is required.
Authorisations and inspection status
The status below applies to the Melsungen site and covers all three product worlds. The figures are taken from the compilation of authorisation and inspection data approved by the management board.
| Authorisation / market | Inspection or validity status |
|---|---|
| EU GMP for human medicinal products | Inspected by the Hessian State Office for Health and Care (HLfGP), June 2025 |
| EU GMP for veterinary medicinal products | Inspected by the Hessian State Office for Health and Care (HLfGP), June 2025 |
| FDA cGMP | GMP status last verified July 2022, via the MRA with the German supervisory authority |
| ANVISA — human medicinal products | Inspection November 2016 |
| ANVISA — medical devices | Inspection April 2026 |
| EAEU (Eurasian Economic Union) | Inspection 11/2024 |
| Medical device audits | Ongoing customer-specific audits by accredited bodies |
| ISO 50001 (energy management) | Valid from 15.11.2025 to 14.11.2028 |
A complete overview of all certifications, approvals and awards is provided on the page covering certifications, approvals and compliance.
Working together and requesting a quotation
Solupharm supports projects across the entire product life cycle: formulation development and galenics, analytical testing, regulatory support, manufacturing, and packaging and serialisation. For medical devices and veterinary products the dialogue should ideally begin early, because the regulatory classification of the product determines the manufacturing and documentation requirements.
- Family-owned company, founded in 1974, 700 employees at the Melsungen site
- Family-run in the second generation. Friedemann Seitz leads the company as managing partner; Ferdinand Seitz has been part of the management as technical managing director in the third generation since 2024. The multi-year joint leadership ensures continuity for long-term supply relationships.
- Current capacity 175 million glass ampoules and 30 million glass vials per year; expansion by 2029: 350 million glass ampoules + 50 million glass vials
- Three manufacturing authorisations at one site: sterile human medicinal products, sterile medical devices, sterile veterinary medicinal products
ORDER VALUE
Order value typically from around EUR 20,000 per order. For every project we review the individual constellation together with the contract giver — including smaller volumes, clinical trial samples or specialised niche products.
AVAILABLE FORMATS
Glass ampoules are filled in volumes of 1–25 ml, glass vials from 2 ml to 250 ml. There are currently no formats outside these volume ranges in the portfolio; for specific requirements, format parts are adapted or additionally sourced as needed in consultation with the customer.
Frequently asked questions on medical devices and veterinary products
Is Solupharm permitted to manufacture sterile medical devices?
Yes. A separate manufacturing authorisation is in place for sterile medical devices, distinct from the authorisation for sterile human medicinal products. In addition, ongoing customer-specific audits by accredited bodies for medical devices take place.
Are sterile veterinary medicinal products manufactured as well?
Yes. A separate manufacturing authorisation is likewise in place for sterile veterinary medicinal products. Official supervision is carried out by the Hessian State Office for Health and Care (HLfGP); the most recent EU GMP inspection for veterinary medicinal products took place in June 2025.
How does manufacturing differ from that of a human medicinal product?
The sterile process itself is identical: batch preparation, sterile filtration through validated 0.2 µm filters or terminal sterilisation, filling under Grade A conditions within a Grade B environment in accordance with EU GMP Annex 1, 100 % inspection and leak testing. What differs is the regulatory classification, the batch documentation, the release logic and the labelling.
In which formats are medical devices and veterinary products filled?
On the same production lines and in the same formats as human medicinal products: glass ampoules in the volume range 1–25 ml and glass vials from 2 ml to 250 ml. There are no restrictions compared with human manufacturing. There are currently no formats outside these volume ranges in the portfolio; for specific requirements, format parts are adapted or additionally sourced as needed in consultation with the customer.
Who holds the marketing authorisation or the technical documentation?
The contract giver. Solupharm holds no marketing authorisations of its own and manufactures exclusively the contract giver’s product on their behalf — for medical devices the technical documentation, and for veterinary products the marketing authorisation dossier, remains entirely with the contract giver.
How is UDI labelling for medical devices covered?
Packaging includes serialisation and aggregation solutions for global track & trace compliance under DSCSA, EU FMD, EU MDR and Russian MDLP. Solupharm applies the UDI marking as part of the packaging process; the assignment of the UDI and the technical documentation remain with the contract giver.
What batch sizes are possible?
Batches between 10 L and 4,500 L. This allows first and validation batches as well as commercial campaigns to be handled through the same quality structures.
Sources, standards and regulatory references
- Regulation (EU) 2017/745 on medical devices (EU MDR)
- Regulation (EU) 2019/6 on veterinary medicinal products
- Implementing Regulation (EU) 2025/2091 on the manufacture of veterinary medicinal products
- EU GMP Annex 1 – Manufacture of Sterile Medicinal Products (revised 2022, in force since 25 August 2023)
- Ph. Eur. 5.1.1 – Methods of preparation of sterile products (terminal sterilisation)
- ISO 14644-1 – Classification of air cleanliness (cleanroom grades A–D, Class 5/7)
- EU FMD – Falsified Medicines Directive 2011/62/EU and Delegated Regulation (EU) 2016/161
- US DSCSA – Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act, 2013)
- ICH – Q8, Q9, Q10 (Quality Guidelines)