Expert: Michael Anisfeld - 3/3/2008

Question
Dear sir,
        we have our client in US having 300 geriatric home with 300 nursing homes and pharmacies they want us to export their drug requirements from india.We are not going to market our drugs. I know there is lot of restriction is there for prescription drugs , What is the formalities fro the generic,OTC and Food supplement products . we have contact with the pharmaceutical manufacturer who is having WHO GMPA certification.

Answer
For you to export to the USA (and it does not matter that you are selling directly to nursing homes), you will need:

a. to register the drug with FDA (using an ANDA)
b. have FDA approve your ANDA (takes about 18 months)
c. have your Indian facility inspected by FDA for compliance with US GMP requirements

I am currently in India assisting a client with exactly the above, and woudl be happy to assist you. Please contact me off-line at manisfeld@globepharm.org.