Scopolamine Base, Hydrobromide & Methylbromide - niche Phyto API’s from Transo-Pharm

Alkaloids Corporation, an Indian manufacturer specialized in sophisticated plant extraction technologies and their marketing, sales & regulatory partner, Transo-Pharm Handels-GmbH, Germany, decided to join hands with the aim to expand Alkaloids’ phytochemical product portfolio and global reach back in 2013. The partnership structure was set up in a way that enables Alkaloids to focus on production & quality excellence while Transo-Pharm focuses on the commercial side, supply chain and adding regulatory support.

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.

Here a summary of all aspects, which make us unique when it comes to Scopolamine Base, Hydrobromide and Methylbromide:

• Experience in producing Scopolamine Salts for more than 18 years
• Installed capacity for up to 4,000 kg p.a.
• Impurity profile is “best in class”
• 60 months stability data available
• Production process is chloroform free
• USFDA & EDQM inspected site (last inspections in May 2018 & February 2018 respectively)
  
• Full regulatory package available for all derivatives
• Long-term & reliable business mentality
• Reliable / secure plant material sourcing – own plantations in Australia

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.

Contact / Productmanager:
Mr. Stephen Mitchard
mitchard@transopharm.de
fon: +49 4107 8778 114