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Post by prosper on Nov 6, 2015 11:42:56 GMT -5
This new application is interesting. The obvious reason is to allow duty free entry of raw materials or possibly components into the US. This will not only defer any import duties on materials until it is processed and shipped to customers in the US, but also allow import of materials duty free for re-exporting finished product. While this will not have a huge impact on cost savings, it is interesting in the implication of potential foreign sales at reduced cost.
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Deleted
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Post by Deleted on Nov 6, 2015 11:45:38 GMT -5
Link ? More details? Most of us here can't see what you have seen
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Post by derek2 on Nov 6, 2015 12:12:18 GMT -5
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kyle
Newbie
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Post by kyle on Nov 6, 2015 12:31:33 GMT -5
Seems as though this is a step being taken in advance of receiving insulin shipments from Sanofi once it is approved.
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Post by mnholdem on Nov 6, 2015 13:43:55 GMT -5
Foreign trade zones of the United States
A Foreign-Trade Zone (FTZ) is an isolated, enclosed and policed area operated as a public utility, furnished with facilities for loading, unloading, handling, storing, manipulating, manufacturing and exhibiting goods and for reshipping them by land, water or air. Merchandise of every description may be held in the Zone without being subject to tariffs (customs duties) and other ad valorem taxes . This tariff and tax relief is designed to lower the costs of U.S.-based operations engaged in international trade and thereby create and retain the employment and capital investment opportunities that result from those operations.
Which companies can be located at an FTZ?
Any company in any industry can apply to be a part of an FTZ. Companies importing to the US on a regular basis and in high volume are the main participants. It is a way to reduce importing costs and save money by participating in special Customs procedures and simplifies processes to run more efficient inventory control systems. The process to register into one is lengthy — 9 to 12 months, depending on the industry and if a FTZ is being created or if you are participating in one that already exists.
en.wikipedia.org/wiki/Foreign_trade_zones_of_the_United_States
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Post by james on Nov 6, 2015 14:10:11 GMT -5
So importing Sanofi insulin to package as Afrezza and send back to Europe or other countries as yet undetermined. I like  |
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Post by cjc04 on Nov 6, 2015 14:25:11 GMT -5
Yes. I really like this idea that SNY's insulin is on the fast track to be in Afrezza.... The #1 reason is because we still have a contract with AMPH that needs to be honored first. SO,,,, that would mean someone is STILL planning to make a LOT of Afrezza.
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Post by mnholdem on Nov 6, 2015 14:27:20 GMT -5
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Post by dreamboatcruise on Nov 6, 2015 20:56:25 GMT -5
Why the speculation this has to do with SNY insulin? Isn't Amphastar's factory in France, so this could just be for it? Though perhaps this has the encouraging implication that it portends exports.
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Post by james on Nov 6, 2015 21:53:44 GMT -5
Good point DBC, I jumped the gun a bit there. Either scenario would be an exciting step. This is certainly only paperwork, so it doesn't mean anything is certain to happen, but a clear signal that they are positioning for an export opportunity. It's also likely to take many months before anything further emerges here.
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Post by mnholdem on Nov 6, 2015 22:11:11 GMT -5
Why the speculation this has to do with SNY insulin? Isn't Amphastar's factory in France, so this could just be for it? Though perhaps this has the encouraging implication that it portends exports. Amphastar Pharmaceuticals, Inc., headquartered in Rancho Cucamonga, California, established in 1996, is a recognized specialty pharmaceutical company that uses state-of-the-art, cGMP compliant facilities to develop, manufacture, and market injectable and inhalation products. In addition to the Corporate Headquarters, Amphastar has five manufacturing facilities located in the United States, China and Europe along with a state-of-the-art New Drug Research Center. www.amphastar.com/about-us.htmlAre you you certain that the Amphastar insulin comes from their French factory? |
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Post by kc on Nov 6, 2015 23:21:45 GMT -5
Not an expert in foreign trade zone. But I think this might be for exporting product from the USA to other countries. Perhaps we are closer to EMA approval then we know. Or perhaps shipping to a country like Israel.
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Post by mssciguy on Nov 6, 2015 23:50:38 GMT -5
Not an expert in foreign trade zone. But I think this might be for exporting product from the USA to other countries. Perhaps we are closer to EMA approval then we know. Or perhaps shipping to a country like Israel. Apparently, the ports in Texas where the Keystone pipeline would have taken oil from Canada for export are also in the same kind of zone category. So, apparently because of those duty exclusions, it was somehow economical to ship tar sands oil for a couple of thousand miles over land for export?   Some of these laws and exclusions make no sense at all. But, the exclusions for MNKD importing insulin for packaging and export make a lot of sense.  Maybe we could all crowdsource a book (all fiction of course) chronicling the birth and development of the first global inhaled powder therapeutics company ever. Maybe, call it, "The Girl with the Tin Foil Hat" (who worked tirelessly behind the scenes to thwart evil Wall Street interests that sought to sabotage the project, out of greed and general misanthropy) -- in the Swedish crime fiction genre. |
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Post by dreamboatcruise on Nov 7, 2015 12:33:24 GMT -5
Why the speculation this has to do with SNY insulin? Isn't Amphastar's factory in France, so this could just be for it? Though perhaps this has the encouraging implication that it portends exports. Amphastar Pharmaceuticals, Inc., headquartered in Rancho Cucamonga, California, established in 1996, is a recognized specialty pharmaceutical company that uses state-of-the-art, cGMP compliant facilities to develop, manufacture, and market injectable and inhalation products. In addition to the Corporate Headquarters, Amphastar has five manufacturing facilities located in the United States, China and Europe along with a state-of-the-art New Drug Research Center. www.amphastar.com/about-us.htmlAre you you certain that the Amphastar insulin comes from their French factory? No I'm not the authoritative source of that info. However, looking at Amphastar's website under facilities, the French site does list insulin production whereas the US one doesn't. Also, previously on this board people discussed it being the source. mnkd.proboards.com/thread/1101/amphastar-old-relationship-factory. I think people stating it as fact in discussions here is where I first acquired that assumption. I can't recall I've seen that in writing directly from MNKD. Though on balance I'd say it looks true. kc... I cannot think of a non export reason why they would do it. It is a big hassle to get approved, so there is the possibility that they put this in motion some time ago when they were more optimistic about where they would be with SNY at this point. I guess I'm at the point in my relationship with MNKD that I tend to tamp down my expectations and try not to read too much into things... especially after that episode a week ago when I was popping champagne corks and doing a happy dance over the increased formulary coverage that turned out to be a chimera. |
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Post by mnholdem on Nov 7, 2015 22:11:02 GMT -5
Well, then, that's a horse of a different color...or, umm, chameleon?
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Some of these laws and exclusions make no sense at all. But, the exclusions for MNKD importing insulin for packaging and export make a lot of sense. 