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Enantiomeric purity – and the associated advantages of Transo-Pharm’s Epinephrine (synonym = Adrenaline)

5/29/2020

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Enantiomeric purity in chiral molecules – such as Transo-Pharm’ s Epinephrine Base and Bitartrate – have been in the focus of the health authorities for some time now. Transo-Pharm is well prepared to fully satisfy the more stringent requirements with their state-of-the-art stereo-selective manufacturing process. Transo-Pharm is therefore in the position to achieve an Enantiomeric Excess (ee) of 99% in commercial production for several years now. This is a significant contribution to ensure patient safety.

Please find the full article below. Learn more about the science behind this topic.

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Adrenaline base and tartrate – DMF filing in Brazil

5/6/2020

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During CPhI 2019 in Frankfurt the Brazilian Health Authority, ANVISA invited stakeholders to their lecture and dialogues “APIs and the New Brazilian Regulation”.
 
The below brief summary outlines the new guidance for filling DMFs (DIFA) in Brazil as well as some API GMP issues. In respect to our Adrenaline base and tartrate we filed the CEP corresponding DMFs following the below option b) plus notification of availability of a CEP.

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  • Home
  • Our Company
    • History
    • Ambition
    • Services
    • Group of companies
    • Partners
  • Quality Policy
    • Our Policy
    • Permissions & Certificates
  • Products
    • Portfolio >
      • Epinephrine Base
      • Epinephrine Bitartrate
      • Clenbuterol HCl
      • Scopolamine Base
      • Scopolamine Hydrobromide
      • Scopolamine Methylbromide
      • ... more Products
    • Portfolio TP USA
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    • TP USA
  • Contact
    • Germany
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