It looks like Fonda is being produced at Dr Reddy's Mexico lab.
The following is taken from the ACL web site.
In the past two years Dr Reddy's has driven the growth of its generic business with the acquisition of Roche's manufacturing plant in Mexico (now banned).
As a bulk manufacturer Dr Reddy's is able to produce fondaparinux at an extremely competitive price (Mexicans are cheap labour), addressing the need to maintain pressure on cost of goods in a generic environment.
Alchemia's fondaparinux will be eligible for an expedited review process. This may reduce the review time from over 16 months to closer to the FDA target of 6 months.
6 months??? ha ha ha ha.
Alchemia 2009 Fonda info
Anyway, I think it most likely that the announcement will be related to the production of Fonda in Mexico, and the ban on imports into the USA from this plant.
I sincerely hope the announcement is not related to this, because I think it is either this, or Approval, one of the two (and I know which one I want).
3 Indian drug manufacturers are now facing bans on the import of their generics into the USA, Dr Reddy's being the latest.
ACL was crazy to go with an Indian drug manufacturer for the USA market, regardless of some extra cost, it should always have gone with a USA drug manufacturer. Bad decision from day 1. As ACL's announcement indicated at the time,they went with the cheapest (and you know what that often gets you).
I just hope we don't have the same problems the other Indian drug maker has, Ranbaxy Laboratories, their import ban into the USA has now kept 30 products out of the USA since 2009.
Cadila, Dr Reddys, Ranbaxy
Gw
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