Expert: Michael Anisfeld - 1/21/2008

Question
QUESTION: What license is required to manufacture prescription drugs in the US for export only to the EU?

ANSWER: It makes no difference whether the drug manufactured in the USA is for domestic sale only, or for export only, or for a combination. All drugs manufactured in the USA need to be registered and approved by FDA (using either the NDA or ANDA registration route), and the manufacturing operations will be inspected for compliance with Good Manufacturing Practices.

Incidentally a few years ago I tried to get around this by manufacturing drugs in an "Foreign Export Zone", but was told by attorneys that an FEZ is only a customs tariff issue, and I would still need to meet all other laws of the US including safety, health, and all FDA regulations.

---------- FOLLOW-UP ----------

QUESTION: Thanks. That's pretty much what I thought but wanted to make sure. What we're thinking about is generic drugs for export. What generally is the time line and cost of getting set up?

Answer
Kevin:

If you are starting from scratch, then figure 2-3 years to build/equip/validate a facility; and figure US$ 5-10 million (depends on complexity of what you want to do)until you get FDA approvals and make first sales.

If you'd like to discuss this in further details, please call me at USA +1 847 914 0922