How Companies in Germany Can Source Pharma Products & CDMO Services (2026 Guide)
Germany • Source Pharma Products & CDMO Services
Introduction
Germany is the largest pharmaceutical market in the EU and one of the most demanding places to supply. Marketing authorisation holders, generic companies, parallel importers, wholesalers and hospital pharmacies all source APIs, finished products and contract manufacturing from inside and outside the EU.
The rules are strict. Medicines are authorised by the Federal Institute for Drugs and Medical Devices (BfArM) or, for vaccines and many biologics, the Paul-Ehrlich-Institut (PEI), or centrally through the European Medicines Agency. Imports from outside the EU also need a German import permit, an EU-GMP-compliant manufacturer and release by a Qualified Person.
This guide explains where supply comes from, what German buyers typically source, how to qualify suppliers, the import documents involved, logistics and the problems that come up most often.
Where supply comes from
German buyers draw on a broad supply base:
- Other EU and EEA countries supply a large share of finished products, sterile manufacturing and packaging, with no import permit needed for goods moving within the single market.
- Switzerland, the UK and the United States are major sources of biologics, specialty products and complex APIs, often covered by mutual recognition agreements on GMP inspections.
- India and China supply most generic APIs and many finished generics, made at sites inspected against EU-GMP.
- South Korea, Japan and Singapore add biologics and biosimilar capacity.
Recent shortages of antibiotics and paediatric medicines have pushed many buyers towards dual sourcing and more supply within Europe. In practice, cost-sensitive generics still rely on Asian APIs, while resilience planning favours a second qualified site in Europe. Our guide to importing medicines into Europe compares the rules across EU markets.
Pharma categories supply
| Category | What German buyers typically source |
|---|---|
| APIs | Generic APIs supported by an ASMF or a Certificate of Suitability (CEP) |
| Finished generics | Oral solids and liquids for statutory health insurer tenders |
| Sterile products | Injectables, lyophilised products, ophthalmics, prefilled syringes |
| Biologics and biosimilars | Drug substance and fill-finish capacity |
| CDMO services | Development, tech transfer, clinical and commercial manufacturing |
| Packaging and release | Secondary packaging, German-language labelling, serialisation, EU batch testing |
Many German companies keep packaging, testing and QP release in the EU even when the bulk product is made elsewhere.
How to source pharma products
1. Define the product and pathway
Set out the molecule, dosage form, pack sizes, volumes and the authorisation route: national through BfArM or PEI, decentralised, mutual recognition or centralised.
2. Confirm EU-GMP status
Check the site's GMP certificate in the EudraGMDP database and review recent inspection outcomes. For sites outside the EU, check whether an EU or mutual recognition authority has inspected them.
3. Review the technical file
Ask for the ASMF or CEP for the API, an eCTD-ready Module 3, Certificates of Analysis, process validation and ICH stability data at Zone II conditions.
4. Audit and agree responsibilities
Audit the site or use a recent independent audit. Sign a quality agreement that defines who holds the import permit, who performs EU batch testing and which QP certifies release.
5. Commercial terms and dual sourcing
Agree price, MOQ, lead time and Incoterms, and plan a second qualified source for critical products. Our CDMO buyer guide covers contract points in more detail, and you can send one request to several GMP-certified suppliers through the PharmaTradz RFQ.
Required documents for import
For finished medicines from outside the EU
- Import permit under the German Medicines Act (AMG) held by the importer
- Certificate confirming that the third-country manufacturer works to EU-GMP standards
- Marketing authorisation, or another legal basis for the import
- Batch Certificate of Analysis and EU batch testing results, unless a mutual recognition agreement applies
- QP certification of each batch before release
- German-language labelling and package leaflet, plus EU safety features where required
For APIs
- Written confirmation from the exporting country's authority that the site meets GMP standards equivalent to the EU's, unless that country is on the EU equivalence list or a waiver applies
- ASMF or CEP reference and Certificate of Analysis
- An import permit for certain categories of active substance
Commercial and customs documents
- Commercial invoice, packing list and bill of lading or air waybill
- Customs certificate from the competent authority confirming the importer holds the required permit
- Temperature records for cold-chain cargo
Logistics and shipping
Main entry points
Sea freight enters through Hamburg and Bremerhaven, and much cargo for Germany also arrives through Rotterdam or Antwerp before moving by road. Frankfurt Airport is the main pharmaceutical air cargo hub, with Munich, Leipzig/Halle and Cologne/Bonn as alternatives.
Indicative transit times
| Origin | Sea freight | Air freight or road |
|---|---|---|
| Asia | Typically 4 to 6 weeks | Air typically 2 to 5 days |
| North America | Typically 2 to 3 weeks | Air typically 1 to 3 days |
| Other EU countries | Not usually needed | Road typically 1 to 3 days |
Cold chain, Incoterms and customs
Distributors must follow EU Good Distribution Practice, including temperature mapping and qualified transport. See our guide to GDP rules and what to check. Many German buyers use FCA or DAP so they control the final leg and the warehouse used before QP release. Customs checks that the importer holds the required permit and certificates before clearing medicines from outside the EU.
Legal and regulatory overview
Authorities
The BfArM handles most national authorisations for chemical medicines, while the PEI covers vaccines, blood products, sera, allergens and advanced therapies. Manufacturing and import authorisations, and GMP inspections of German sites, are issued and carried out by the regional authorities of the federal states.
Manufacturing and import authorisation
Any company that manufactures or imports medicines from outside the EU needs an EU-GMP manufacturing or import authorisation. It must employ a Qualified Person, who certifies that each batch was made and tested in line with EU-GMP and the marketing authorisation before it is released.
APIs and falsified medicines rules
APIs imported into the EU must be made to GMP standards equivalent to the EU's, shown by a written confirmation or an equivalence listing. Most prescription medicines must carry a unique identifier and an anti-tampering device, checked through Germany's national verification system.
Market access
New active substances go through an early benefit assessment that affects reimbursed prices. Generics are shaped by reference prices and rebate contracts tendered by statutory health insurers. Individual imports of medicines not authorised in Germany are possible in limited cases through pharmacies, for specific patients.
Common challenges and practical solutions
| Challenge | Practical solution |
|---|---|
| Missing written confirmation for an API | Confirm the exporting country's position before ordering and keep copies with each batch. |
| No EU GMP inspection of the site | Prefer sites with a current EudraGMDP entry or plan for an inspection. |
| QP release delays | Agree batch documentation and testing plans with the QP before the first shipment. |
| Serialisation errors | Test data uploads and pack coding before launch. |
| Tender price pressure | Build realistic cost and supply-security clauses into rebate contract bids. |
| Single-source risk | Qualify a second API or finished-product source for critical lines. |
Most problems come from unclear responsibilities between supplier, importer and QP. Writing them down early saves weeks later.
Conclusion
German buyers can source well from Europe, North America and Asia, provided each supplier meets EU-GMP and the import chain is clear: who holds the import permit, who tests, and which QP releases. Combine cost-efficient sources with a second qualified site for critical products, and plan for serialisation and German labelling from the start.
PharmaTradz works with GMP-certified manufacturers and CDMOs across Asia, Europe, the Americas and Africa, and can help you compare suppliers for APIs, generics and contract manufacturing. More resources are on our Germany hub.
Frequently Asked Questions
Which authority approves medicines in Germany?
The BfArM approves most medicines nationally, the PEI covers vaccines and many biologics, and some products are authorised centrally for the whole EU.
Who issues import permits for medicines in Germany?
The regional authority of the federal state where the importer is based, not the BfArM or the PEI.
What does a Qualified Person do?
The QP certifies that each batch was made and tested in line with EU-GMP and the marketing authorisation before it can be released for sale.
Do APIs from outside the EU need a written confirmation?
Yes, unless the exporting country is on the EU equivalence list or a waiver applies. It confirms the site meets GMP standards equivalent to the EU's.
Which medicines need safety features in Germany?
Most prescription medicines need a unique identifier and an anti-tampering device, checked through the national verification system.
Where does most pharmaceutical air cargo arrive in Germany?
Frankfurt Airport is the main hub, with Munich, Leipzig/Halle and Cologne/Bonn also handling pharmaceutical cargo.
Source Pharma Products & CDMO Services — other markets
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