Transo-Pharm and Alkaloids have worked hard over the past years to make a solid regulatory platform for Scopolamine Base, Hydrobromide and Methylbromide available in all markets worldwide. This basis consists of ASMFs, which have been approved by highly regulated markets (Europe, USA & Asia). All 3 derivatives are already supplied commercially in multiple markets.
Also from a GMP perspective we are in an excellent position to serve all markets adequately; USFDA & EDQM have approved the manufacturing unit of Alkaloids.
Additional company information:
Transo-Pharm has a long history in distribution & marketing of APIs specially those emanating from previous market leader, such as Scopolamine derivatives & Digoxin. In addition, Transo-Pharm has experience in handling GMP and regulatory affairs related aspects for these type of APIs.
Alkaloids has decades of experience and expertise in developing and manufacturing phytochemicals for the pharmaceutical industry. Their GMP/quality compliance systems and the avid desire to adapt to changes in manufacturing techniques has enabled Alkaloids to supply consistently phytochemicals to the US & EU. The inspection reports by the USFDA, other authorities and by several multinational companies are encouraging.