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General Information
Provepharm research results in the first cGMP Pharmacopoeial grade Methylene Blue (Methylthioninium chloride Ph.Eur) obtained using
- New innovative synthetic pathway
- Heavy-metal-free process
- “Clean chemistry” process involving pharmaceutical grade reagents
Provepharm offers Methylene Blue with
- Metal impurity concentrations up to 50 times lower than current pharmacopoeial limits
- Full regulatory package in preparation including USDMF, EDMF and CEP including up to 12 months stability data under ICH conditions
- Stock build to ensure future reliable supply
Provepharm Methylene Blue enables confidence to
- Update and resume commercialisation of existing Marketing Authorisations containing methylene blue as drug substance in Europe
- Ensure compliance with world best practice for existing products containing methylene blue as drug substance commercialised around the world
- Undertake research for new therapeutic applications
of Methylene Blue
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