Hi,
the only element of risk UNS will face , during high volume production are the raw materials which are supplied to them for product development/ manufacturing by their suppliers.if one or more suppliers fall short, for what component they supply and cannot meet the high ramp up demand, UNS will have a big issue on there hands. This is the biggest and probably the only potential risk they still face.
Sanofi is a perfect example of that. On of the component of the lovenox drug is a derivative from a pigs intestine. This particular derivatives cost went up 500% over night virtually , which created a major issue for the lovenox costing forecast. This is one of the set backs sanofi faced from their supplier, and it had nothing to do with UNS and it's product confidence. I am lead to believe that sanofi is 150% committed is ramping proceeding . Some countries have less stringent regulations than others, thus sanofi is currently focusing heavily on these countries, as we speak to get the ball rolling.
Cheers
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