Contract development and cGMP manufacturing of pharmaceutical active ingredients (APIs) in the milligram to kilogram range
Chemisch-pharmazeutisches Labor, Rolf Sachse GmbH
Berlin-Charlottenburg (Stieffring 14)New on Amplifa
About CPL Sachse
Chemisch-pharmazeutisches Labor, Rolf Sachse GmbH (CPL Sachse) is a contract and toll manufacturer of organic pharmaceutical active ingredients (APIs) and selected intermediates for human and veterinary applications. Production is carried out in accordance with cGMP under the EU GMP Guide Part II (ICH Q7) in a GMP facility in Berlin-Charlottenburg covering approx. 1,400 m², whose manufacturing area has been operated as a cleanroom area (ISO 8) since 2014. The service portfolio includes synthesis development with feasibility studies, the manufacture of active ingredients for toxicological and clinical trials, certified reference substances, as well as impurities, degradation products and metabolites. In addition, the company offers analytical development and routine analytics (including GC/MS, GC/FID, stability testing), formulation development including laboratory-scale liposome production, and regulatory services (ASMF/DMF, CTD). Currently, nine certified active ingredients are manufactured exclusively for customers for market supply; larger batches up to 1,000 kg are realized by CPL Sachse with selected partners. Customers come from the pharmaceutical industry, chemical industry, research, and animal health.
- Site
- Berlin
- Processes
- API manufacturing (active ingredient production, contract/toll manufacturing, mg to kg, cGMP, Manufacture of active ingredients for toxicological and clinical trials, Manufacture and certification of reference substances (active ingredients, impurities and, Manufacture of impurities and degradation products as well as metabolites, Validation of manufacturing and purification processes, Synthesis development (organic syntheses for active ingredients, feasibility studies, more than 30, Analytical development (routine analysis according to pharmacopoeia methods, development of new, Gas chromatography (GC/MS, GC/FID) for the determination of residual solvents
- Materials
- Anagrelide Hydrochloride Monohydrate, Atipamezole Hydrochloride, Clenbuterol Hydrochloride, Detomidine Hydrochloride, Medetomidine Hydrochloride, Methacetin (13C), Nabilone, Phenoxybenzamine Hydrochloride
- Certificates
- GMP certificates (API manufacture and testing, human/veterinary), cGMP in accordance with EU GMP Guide Part II (ICH Q7), GMP certificates (manufacture and testing of APIs, human/veterinary)
- Founded
- 1982
- Employees
- 28–35
- Industries
- Pharmaceutical industry, Chemical industry, Research & Development (R&D), Animal health
- 01
Synthesis development incl. feasibility study
- 02
Analytical development and method validation
- 03
cGMP manufacturing in an ISO 8 cleanroom
- 04
Quality control and stability testing
- 05
Validation of manufacturing and purification processes
- 06
Regulatory documentation (ASMF/DMF, CTD)
Active Ingredients & Substances
Organic pharmaceutical active ingredients (APIs)
Contract and toll manufacturing in the milligram to kilogram range for human and veterinary applications, cGMP-compliant in accordance with ICH Q7.
Anagrelide Hydrochloride Monohydrate
Certified active ingredient for market supply according to USP quality.
Atipamezole Hydrochloride
Certified active ingredient with HPLC purity ≥ 99.8 area %.
Clenbuterol Hydrochloride
Certified active ingredient according to Ph. Eur. (CEP available).
Detomidine Hydrochloride
Certified active ingredient according to Ph. Eur. (CEP available).
Medetomidine Hydrochloride
Certified active ingredient with HPLC purity ≥ 99.8 area %.
Methacetin (13C)
Isotope-labeled active ingredient with HPLC purity ≥ 99.0 area %.
Nabilone
Certified active ingredient with HPLC purity ≥ 99.0 area %.
Phenoxybenzamine Hydrochloride
Certified active ingredient with HPLC purity ≥ 99 area %.
Reference substances
Certified active ingredients, impurities and degradation products, and metabolites as identity or assay standards.
Site
Berlin-Charlottenburg
DEHeadquarters, GMP facility with laboratory and production (ISO 8 cleanroom)
- Lot size
- Milligram to kilogram range
- Materials
- Organic pharmaceutical active ingredients (APIs) and intermediates
- ISO 8 cleanroom area
- MAXIMATOR® high-pressure extruder for liposome production by filter extrusion
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| API manufacturing (active ingredient production, contract/toll manufacturing, mg to kg, cGMPGuss | – | – | – | – | organic pharmaceutical active ingredients (APIs) for human, selected intermediates |
| Manufacture of active ingredients for toxicological and clinical trialsGuss | – | – | – | – | organic APIs |
| Manufacture and certification of reference substances (active ingredients, impurities andGuss | – | – | – | – | organic active ingredients, impurities and degradation products, metabolites |
| Manufacture of impurities and degradation products as well as metabolitesGuss | – | – | – | – | organic compounds |
| Validation of manufacturing and purification processesGuss | – | – | – | – | APIs |
| Synthesis development (organic syntheses for active ingredients, feasibility studies, more than 30Engineering | – | – | – | – | organic compounds, APIs |
| Analytical development (routine analysis according to pharmacopoeia methods, development of newPrüfung | – | – | – | – | pharmaceutical ingredients, active ingredients (APIs), medicinal products |
| Gas chromatography (GC/MS, GC/FID) for the determination of residual solventsPrüfung | – | – | – | – | pharmaceutical ingredients, active ingredients (APIs), medicinal products |
| Analytical testing of active ingredients and medicinal products (GMP-certified)Prüfung | – | – | – | – | active ingredients, medicinal products |
| Development of parenteral formulations (incl. manufacture and testing of laboratory samples)Engineering | – | – | – | – | active ingredient formulations |
| Development of liquid formulations for topical or oral application (incl. laboratory samples)Engineering | – | – | – | – | active ingredient formulations |
| Development of capsule formulations (incl. laboratory samples)Engineering | – | – | – | – | active ingredient formulations |
| Development and manufacture of liposome formulations on a laboratory scale (MAXIMATOR®Engineering | – | – | – | – | liposomes, active ingredient formulations |
| Selection and testing of primary packaging materials (suitability and compatibility of packaging)Prüfung | – | – | – | – | primary packaging materials |
| Regulatory support (ASMF/DMF, CTD, quality overall summaries, deficiency letters,Engineering | – | – | – | – | APIs, medicinal products |
Additional services
Quality
CPL Sachse is regularly audited by customers and inspected by the State Office for Health and Social Affairs (LAGeSo) Berlin; after the last inspection in March 2026, new GMP certificates were issued for the manufacture of active ingredients as well as the analytical testing of active ingredients and medicinal products. The last FDA inspection in June 2017 was successful.
| Evidence | Berlin |
|---|---|
| GMP certificates (manufacture and testing of APIs, human/veterinary) | |
| cGMP in accordance with EU GMP Guide Part II (ICH Q7) |
History
- 1982
Founded as 'Chemotechnischer Service Rolf Sachse' in Berlin-Spandau by Rolf Sachse; fields of activity: pharmaceutical analysis and development of syntheses for active ingredient production.
- 1988
Relocation to Berlin-Frohnau and renaming to 'Chemotechnisches Labor Rolf Sachse'; accreditation as a testing laboratory for pharmaceuticals, active ingredients, water and soil samples.
- 2001
Conversion into a GmbH and renaming to 'Chemisch-pharmazeutisches Labor, Rolf Sachse GmbH'; relocation to Berlin-Charlottenburg and start of GMP active ingredient production.
- 2008
Rolf Sachse steps down as managing director effective 31.12.2008 and thereafter works as a freelance consultant.
- 2009
Extensive renovation and expansion of the facility to increase laboratory and production capacities.
- 2013–2014
Conversion of the manufacturing area into a cleanroom area (ISO 8).
- 2015
First inspection by the U.S. regulatory authority FDA.
- 2017
Successful FDA inspection in June 2017.
- 2021
20th anniversary of the company since its conversion into a GmbH.
- 2022
Company founder Rolf Sachse passed away on 15.08.2022.
- 2026
New GMP certificates from LAGeSo Berlin following the inspection in March 2026.