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Pharmaceuticals/Export of UK/EU licensed product to USA
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Question
Can I export UK/EU licenced product to the US for sale?
No. You can only export pharmaceutical products (from anywhere in the world) into the USA, when the product has been approved by the FDA (you need to submit an New Drug Application), and the facility manufacturing the product has been approved by an FDA inspector as meeting US-GMPs.
At our company, Globepharm, we specialize in assisting companies with both these activities, and we would be delighted to assist you. Please contact me off-line at manisfeld@globepharm.org
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Pharmaceuticals
Answers by Expert:
Michael Anisfeld
Expertise
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
Experience
Past/Present Clients
UN agencies (UNFPA, UNICEF, UNIDO)
Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries
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