There's seriously no reason why there should ever be an estradiol shortage. Millions of cis women take it for many reasons, like menopause.
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On 3/10, Par filed a notice with the FDA for a "manufacturing change or addition". They use contract manufacturers overseas, so...
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There is a good chance this is to change manufacturers or to modify the process in some way that isn't supposed to affect the drug
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In a 2014 SEC filing, Par acknowledges the risk of mfg delays due to using overseas suppliers, so this couls be related.
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*could. Anyhow, contract mfg is tricky because they're subject to FDA regulations. Hard to spin up a new one. Takes > 6 mos.
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So the mfg is at least aware of the risks of single point of failure. Overseas mfg can be affected by stuff we don't hear about.
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FWIW, perrigo shut down their 20mg/mL dose to move up to 40. That should be available in 8-10 weeks.
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This is all public but hard to find. Just query 'delestrogen' at this database: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm …
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Would you be willing to like, maybe Skype at some point and we can do a little Gender Analysis interview about this?
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