Clinalfa® is Bachem’s brand name for sterile peptides. Clinalfa products are manufactured and released by Bachem Distribution Services GmbH, Weil am Rhein, Germany.
The following Clinalfa product lines are available from Bachem:
Clinalfa basic products are sterile freeze-dried peptides readily available from stock. The supply of Clinalfa basic peptides is accompanied by Bachem’s Certificate of Analysis (CofA) signed by Bachem’s Qualified Person (QP).
Clinalfa plus products are sterile freeze-dried or ready-to-use liquid formulations made according to customer requirements. In many cases, the active pharmaceutical ingredients (APIs) and the resulting Clinalfa products are proprietary products of Bachem’s customers. Based on agreements between the customer and Bachem, Bachem’s Qualified Person (QP) may release the products for use in a specific clinical study approved by the competent authority, and also for market approval.
Bachem offers related services to Clinalfa basic and Clinalfa plus products, i.e. formulation development, compatibility studies, stress test and post-release stability studies, CMC-documentation for IMPD and IND, drug master file and other services.