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Providing regulatory documents - request form

3/22/2022

1 Comment

 
Part of our Transo-Pharm service in regulatory affairs is to send necessary documents, such as Drug Master Files, Letter of Access / Authorisation and Declaration of Accesses to CEPs to our customers for their regulatory activities.

​The scope is wide with many special wishes and requirements.
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Transo-Pharm's succesful co-operation with the USP

1/13/2021

0 Comments

 
With the next-to-last USP 42.2 update, a lot of changes were implemented in the Epinephrine USP monograph with the help of Transo-Pharm. Due to the high enantiomeric purity and the state-of-art HPLC test method, Transo-Pharm was in the best position to effectively support the US FDA.
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epinephrine_base_usp.pdf
File Size: 222 kb
File Type: pdf
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Scientific and Regulatory Support at Transo-Pharm

9/23/2020

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Our scientific team in Germany (6 members including 3 PhDs - backgrounds in chemistry and pharmacy) has over 50 combined years of work experience.
sra_support_tph.pdf
File Size: 126 kb
File Type: pdf
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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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Nitrosamine risk evaluation

2/28/2020

0 Comments

 
No Nitrosamine risk with Epinephrine Base / Bitartrate from Transo-Pharm as our recently conducted risk evaluation report reveals.

The conclusion is now available on request.
0 Comments

Adrenaline CEP's: out of range country acceptance

1/15/2020

0 Comments

 
CEPs are recognised by the European Pharmacopoeia member states and by a number of other countries. A full current list of the Ph. Eur. members is available on EDQM website. Based on Transo-Pharm's experience we easily penetrated those markets utilizing our CEPs for Adrenaline Base as well as Tartrate.

But what about countries outside EU or Ph. Eur. member states? 

Meanwhile we adjusted our filing strategy in this matter and our Adrenaline CEPs have been submitted to several “out of range” countries. 


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  • Home
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    • Portfolio >
      • Epinephrine Base
      • Epinephrine Bitartrate
      • Clenbuterol HCl
      • Scopolamine Base
      • Scopolamine Hydrobromide
      • Scopolamine Methylbromide
      • ... more Products
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