Product analytics & market release of hydroxy-chloroquine & chloroquine

Speculation is ongoing that a decade-old malaria drug may be one of the key medications slowing down the spread of the novel coronavirus (COVID-19). This dedicated drug is comprised of the chemical chloroquine.

Although these chemicals are not legislatively approved to treat COVID-19, an off-label use is in discussion. Recent studies suggest that chloroquine is effective in combating this new virus strain. As a general drug, it has the potential of being mass produced at the required scale to combat a global pandemic.

Although chloroquine is a staple antimalarial drug, it has only been prescribed very rarely in recent years. Antimalarial drugs containing the active ingredient hydroxychloroquine are currently also being tested in several laboratories worldwide.

More extensive studies are currently being done to test the functionality of these drugs. In a press conference on 19.03.2020, FDA (Food and Drug Administration) commissioner Stephen Hahn informed that President Trump authorized the FDA to take a closer look at expanding the access of chloroquines to corona-infected patients.

While functionality is being tested, the drug will also have to undergo safety testing to ensure that no harmful chemicals reside in the drug. To confirm the safety of these drugs, Tentamus Group members can take over the quality control and market/batch release.

Tentamus Group has laboratories in Europe, which are specialized in quality control and batch certification. One of these pharmaceutical analysis labs is DSI-pharm, located in Bremen/Oldenburg, Germany. This laboratory is dedicated in analysing drugs for safety and holds a certificate of GMP compliance and manufacturer authorization. DSI-Pharm is therefore certified to release products to the market by its own qualified person.

Feel free to contact DSI-pharm in Europe using the following contact information:

DSI-pharm

Dr. Serap Acikgöz
General Manager Pharma
DSI-pharm
+49 441 3613265 449
serap.acikgoez@tentamus.com

 

 

 

 

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