Alkaloids produces two grades on a commercial basis: non-micronized and micronized material.
The existing CEP has been amended and now includes the micronization step, hence the current version No. R1-CEP 2010-298-Rev 01 covers now both grades, micronized and non-micronized material. The revision also includes editorial updates and notifications. We believe this new version represents a significant improvement over the previous version and will support our customers with their drug product registrations.
The micronization step is done in-house. Importantly, the micronized material from Alkaloids does not require any special cooling during transportation or storage.
Enantiomeric purity – and the associated advantages of Transo-Pharm’s Epinephrine (synonym = Adrenaline)
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.
Transo-Pharm continues to closely monitor the widespread impact of the coronavirus disease (COVID-19). The safety and well-being of our employees, customers, partners and suppliers remains our top priority. Additionally, we are committed to supporting our public safety and enterprise customers during this time.
A highly skilled team has been put in place and is closely monitoring the situation around the world. We have taken measures to manage the virus’ impact by following guidance from the German Robert Koch Institute, World Health Organization and local governments. These measures include:
2. Update: Given the current Coronavirus (SARS-CoV-2) development it is reassuring that we can continue to ensure stable supply of both products. We have sufficient inventory in our German warehouse.
1. Update: Please find now coronavirus statement issued by Syn-Tech, Taiwan below attached.
As the coronavirus continues to spread in China, the Chinese Government extended the New Year holiday one additional week to February 9th. Some API factories may not re-open until the 16th to help contain the spread of the virus.
API shortages will be expected due to the extension of Chinese New Year.
Transo-Pharm has a significant stock of Epinephrine Base and Bitartrate manufactured by Syn-Tech (Taiwan) available to our global customers.
Transo-Pharm does not expect any shortages in supply due to the coronavirus.
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.
Coronavirus outbreak in China may disrupt global drug supply chains - but not at Transo-Pharm !
We at Transo-Pharm assure always continuous supply of API Phenylephrine HCL from our CMO, Hisoar, China.
The Coronavirus has no negative impact on our supply chain.
Due to extended stocks Transo-Pharm is able to supply the markets from their warehouse in Germany without any disruption. The next production campaign of the API will start earlier in order to have more time for production, release and the transport out of China. A continuous supply of API for the global customers is guaranteed.
Please find our update here