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CPL Sachse - CDMO/CMO
We are an established order and contract manufacturer of active pharmaceutical ingredients (drug substances) and selected intermediates ranging from milligrams to kilograms. Our production follows cGMP and is in accordance with the EU-GMP-Guideline Part II (ICH Q7). We are regularly inspected by the responsible local authority which issues us with drug substance-specific GMP certificates. We are currently manufacturing nine certified APIs for market supplies exclusively for our customers on a regular basis.
Synthesis development
We have more than 30 years of experience in the development of organic syntheses for drug substances (APIs). On receipt of an order for synthesis development, we first research the latest state-of-the-art and conduct a feasibility study if applicable. This includes the proposed synthetic route, a schedule, and...
Germany
Local time:
Modern GMP facility
Team of academics and technical experts
Small to large batch sizes possible
Production scale:
Response time:
Services
Drug Substance (CDMO/CRO)
Drug Product (CMO)
Contact Chemisch-pharmazeutisches Labor, Rolf Sachse GmbH for Contract Services Expertise
Connect with Chemisch-pharmazeutisches Labor, Rolf Sachse GmbH, a leading pharmaceutical company from Germany. They offer specialized Drug Substance (CDMO/CRO), Drug Product (CMO). Contact Chemisch-pharmazeutisches Labor, Rolf Sachse GmbH for free and discover if they are the perfect partner for your pharmaceutical needs.
Drug Substance (CDMO/CRO)
Drug Substance (often called the API, active pharmaceutical ingredient) is the active ingredient that becomes the core of a medicine
before it is formulated into tablets, capsules, injectables, or other dosage forms.
Outsourcing this stage typically involves a pharmaceutical CDMO that provides CDMO services such as process development,
scale-up, tech transfer, and CDMO manufacturing under GMP.
We use CDMO/CRO here because many partners combine development and manufacturing, and some also offer CRO-style support
(specialized analytical development, early-stage research services, feasibility work). Buyers searching for CDMO outsourcing usually want one thing:
a partner that can reliably deliver the right API at the right quality level for the target markets (FDA, EMA, PMDA and others).
These quick notes help you evaluate CDMO outsourcing partners for drug substance manufacturing without reading a full outsourcing handbook.
In drug substance work, a CDMO typically owns the “development + manufacturing” path, while CRO services are used to accelerate specific research or analytical tasks.
In practice, many contract development manufacturing organization partners offer both.
Common questions buyers ask when comparing CDMO companies for drug substance (API) manufacturing.
Drug substance manufacturing is the development and production of the active ingredient (API) used in a medicine.
It often includes process development, scale-up, GMP manufacturing, analytical methods, and documentation for target markets.
A pharmaceutical CDMO is a contract partner that provides development and manufacturing services, often end-to-end:
process development, scale-up, tech transfer, validation, and GMP production (CDMO manufacturing).
Many drug substance partners offer both CDMO execution and CRO-style support, such as specialized analytical development,
feasibility work, and early-stage research services. The right choice depends on scope, not the label.
Involve CRO support when you need specialized analytical development, rapid feasibility work, or research-heavy services that complement the CDMO scope.
Many buyers use CDMO services for development + manufacturing and add CRO services for specific tasks.
Start with scope (development vs manufacturing), then match capability (chemistry/biology, potency, scale),
validate GMP credentials and supported markets (FDA/EMA/PMDA), and finally check capacity and lead times.
Include API type, stage, batch sizes and annual demand estimate, target markets, known impurities/critical quality attributes,
required containment/OEB, timeline, and which services you expect (process development, tech transfer, GMP manufacturing, QC).
If potency or OEB limits require closed handling and validated containment, shortlist partners with dedicated suites,
documented exposure controls, and experience with similar compounds at comparable scales.
Very. In-house analytical development and QC often reduce transfer friction and shorten timelines.
Ask what is truly in-house (methods, stability, impurity profiling) versus outsourced.
Look for relevant inspections/certifications aligned to your target markets (FDA, EMA, etc.), and confirm that the specific facility and suites are in-scope.
Mature quality systems (deviations/CAPA, change control) matter as much as certificates.
Process complexity, containment requirements, analytical method readiness, documentation needs for target markets, and capacity constraints.
Clear scope and good transfer documentation reduce delays.
Sometimes, but often facilities and expertise differ. Validate modality fit (biologics vs chemical-synthetic),
equipment and containment, and comparable project references.
Compare on scope (what’s included), proven experience at similar scales, GMP maturity, analytical capabilities, supported markets, lead times,
and how change control and deviations are handled. Use filters above to remove obvious mismatches first.
What is Drug Substance outsourcing (CDMO/CRO)?
Drug Substance buyer guide (CDMO/CRO)
When do you need a CDMO vs CRO (or both)?
What to ask a Drug Substance CDMO
Key terms (Drug Substance)
Drug Substance CDMO services FAQ
What does “Drug Substance manufacturing” mean?
What is a pharmaceutical CDMO?
Why do you label this as CDMO/CRO?
When should I involve a CRO in drug substance work?
How do I shortlist CDMO companies quickly for API manufacturing?
What should I include in an RFQ to a Drug Substance CDMO?
Do I need a dedicated HPAPI facility?
How important is in-house analytical capability?
What GMP evidence should I look for?
What affects CDMO outsourcing timelines the most?
Can a biotech CDMO also support small molecule APIs?
How do I compare CDMO services fairly across providers?
Drug Product (CMO)
What is Drug Product outsourcing (CMO)?
Drug Product is the finished dosage form patients use (tablets, capsules, injectables, sprays, creams, etc.). Drug Product outsourcing typically means working with a Contract Manufacturing Organization (CMO) to manufacture, validate, package, and release finished dosage forms under GMP for your target markets.
A pharmaceutical CMO focuses on manufacturing execution: tech transfer, GMP production, validation, packaging, and supply continuity. If you still need substantial formulation work or process development, you may need a broader contract development manufacturing organization scope. This directory is optimized for buyers who are comparing CMO services and contract manufacturing services by real-world fit.
- Choose a CMO when your process is defined and you need manufacturing capacity, validation, packaging, and predictable supply.
- Prioritize dosage form fit (sterile vs non-sterile, device needs, line compatibility, packaging components).
- Verify regulatory readiness for your markets: FDA/EMA experience, documentation, change control, and release workflow.
- Use this pharmaceutical CMO directory to shortlist and request quotes from the right providers faster.
Drug Product buyer guide (CMO)
Use this quick guide to evaluate CMO services and avoid common delays in tech transfer, validation, and packaging.
How to choose the right Contract Manufacturing Organization
- Dosage form fit: match the exact formats you need (sterile vs non-sterile, device needs, packaging lines).
- Tech transfer ownership: confirm who owns documents, training, and change control.
- Validation strategy: align to stage and markets (clinical vs commercial).
- Packaging reality: line compatibility and component lead times are frequent blockers.
- Regulatory compliant CMO: confirm inspections/certifications relevant to your target markets.
What to include in your first message (RFQ)
- Dosage form: tablets/capsules, liquids, semi-solids, sterile injectables, inhalation, etc.
- Fill-finish format: vials, prefilled syringes, ampoules, lyophilized powders, pens.
- Stage + markets: investigational vs commercial; FDA/EMA/others.
- Volumes: batch size and annual demand estimate.
- Constraints: cold chain, device/combination requirements, special packaging.
- Timeline: desired start date, first batch, launch window.
Common pitfalls in Drug Product outsourcing
- Capacity surprises: the facility can do it, but not in your timeframe.
- Packaging constraints: components and line compatibility often take longer than expected.
- Validation gaps: misaligned validation scope causes delays and rework.
- Scope confusion: if development is still needed, pure CMO execution may not be enough.
Drug Product CMO services FAQ
Practical answers buyers look for when hiring a CMO and comparing contract manufacturing companies.
What is a Contract Manufacturing Organization (CMO)?
A CMO is a contract partner focused on manufacturing execution under GMP. For drug products this often includes tech transfer, validation, routine manufacturing, packaging, and supply continuity.
What does “CMO services” usually include?
Typical CMO services include tech transfer, GMP manufacturing, validation support, packaging, QC testing where applicable, and batch release workflows aligned to target markets.
When should I choose a CMO instead of a CDMO?
Choose a CMO when the formulation and process are largely established and you need manufacturing capacity and reliable supply. Choose CDMO scope when you still need development work (formulation/process development/method development).
How do I shortlist pharmaceutical CMO providers fast?
Start with dosage-form fit (sterile vs non-sterile, device needs), then filter by certifications and target markets (FDA/EMA), capacity, and realistic timelines. This directory is built for that workflow.
What should I include in an initial inquiry to a CMO?
Include dosage form, stage, batch sizes and annual demand estimate, target markets, packaging format, cold chain needs, and key quality expectations. Clear inputs lead to faster, more accurate proposals.
What is fill-finish and why does it matter?
Fill-finish is the step where drug product is filled into final containers (vials, syringes, pens) and packaged. Facility design, sterility assurance, and packaging components often drive timelines and feasibility.
How do I evaluate a regulatory compliant CMO?
Confirm market experience (FDA/EMA), inspectable quality systems (deviations/CAPA, change control), documentation readiness, and whether the specific facility/suites are in-scope for your product type.
What affects lead times the most in drug product contract manufacturing?
Capacity windows, packaging component lead times, validation strategy, and analytical/QC readiness are common drivers. Sterile injectables and complex packaging formats typically require longer planning.
Do contract manufacturers handle packaging too?
Many do, but packaging capability is not universal. Validate line compatibility, serialization requirements, component sourcing responsibilities, and release workflows.
What are “custom CMO services” and when do I need them?
Custom CMO services usually mean tailored packaging, special handling (cold chain), device requirements, or non-standard batch strategies. Use them when your product needs go beyond a standard manufacturing run.
How do I compare contract manufacturing companies fairly?
Compare on dosage-form fit, proven experience, certifications and market history, QA maturity, realistic lead times, and packaging capabilities. Use filters first, then deep-dive with RFQs.
Is an NDA required before contacting a CMO?
Often not for a high-level brief. Most buyers share a concise scope first and sign an NDA when detailed transfer documents are needed.
Why use a pharmaceutical CMO directory instead of searching manually?
Manual search is slow and inconsistent. A directory approach lets you compare providers by the same criteria (dosage form, certifications, markets, scale), so you can shortlist faster and avoid contacting mismatched suppliers.
What is the difference between contract manufacturing services and CDMO services?
Contract manufacturing services usually focus on execution and supply. CDMO services typically include development work alongside manufacturing. For drug product, choose based on whether you need development or mainly manufacturing capacity.
Can I send one request to multiple CMOs?
Yes. If you’re unsure, use the open inquiry option: one message with your requirements routed to relevant CMOs, helping you compare responses without repeating the same work.
What are pharma contract fillers?
“Pharma contract fillers” usually refers to CMOs that perform fill-finish operations, especially for sterile injectables. Verify container formats, aseptic capabilities, and packaging lines for your product.