Chemisch-pharmazeutisches Labor, Rolf Sachse GmbH
Company Details
Status: Private
Employees: 11-50
Location:
Stieffring 14, Berlin, Berlin, DE, 13627
Type:
sample
sample
Technology:
sample
About: CPL Sachse produces APIs for human and veterinary use. We manufacture APIs under cGMP for (pre-)clinical development and market supply up to ≤ 50 kg scale. The company has been successfully inspected multiple times by EMA (LaGeSo) and FDA. The following compounds are available from us under a GMP certificate from our local authority:
- Anagrelide,
- Atipamezole,
- Clenbuterol (CEP),
- Detomidine (CEP),
- Medetomidine,
- Methacetin(13C),
- Nabilone
- Phenoxybenzamine.
Further APIs as well as reference standards for APIs and impurities are available on request. Moreover, we carry our route scouting for NCEs and develop and validate processes as well as analytical methods required to test the APIs and the subsequent drug products. Furthermore, we offer stability tests according to ICH guidelines. The company introduced and offers Maximator® HPE. This continuous high pressure extruder (HPE) allows rapid and reproducible large-scale production of unilamellar liposomes. Finally, we offer all regulatory services required for the preparation and submission of a pharmaceutical dossier (for APIs and drug products).
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Chemisch-pharmazeutisches Labor, Rolf Sachse GmbH | Active clinical trials on ClinicalTrials.gov
Active Clinical Trials Count | 0
No Active Trials Found On ClinicalTrials.gov.