Pharmaceuticals/Mesna

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Question
Dear Mr. Anisfeld,
Sir,

I'd like to ask you about Mesna.As you know Mesna injection is being used as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis, having said that it has been claimed on the label as "Cytotoxic agent" by some manufacturers. Does it mean it has to be manufactured in a dedicated site and manufacturing facilities? Any technical response from you would be greatly appreciated.
Kind regards,
Afshin.

Answer
Afshin:

If the product is a cytotoxic as you state, then, YES, to meet EU and US regulations, you need to manufacture the product in a dedicated manufacturing facility.

Check out this industrial magazine article for details:
http://www.contractpharma.com/issues/2014-11-01/view_features/the-new-eu-gmps-fo

Good Luck,

Pharmaceuticals

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Michael Anisfeld

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Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements

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