M
I agree with Somashekar on the utmost importance of having the agreement of the other company's NB with whatever you will do.
While you would be the Distributor under US FDA rules if such applied, you may be the Private Label Manufacturer under MDD. Responsibilities are quite different between the two cases. A good guidance regarding OEM vs. PLM is provided at http://www.zlg.de/download/ab/309_0607_B16EN.pdf.
(...) since we are the distributor at this time (...)