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Hello. Both prescription drugs are for the thyroid (or for those who don't have a thyroid anymore). Levothyroxine is the generic.
Does anyone know where each or any of them are produced? In other words, are they made in China or the USA?
Thank you.
Interesting question. I take it, too. Looked it up and learned that since 2016, it is the most-prescribed drug in the United States.
But where it's made is a little murky. It's officially made by places in the USA, but the given address of a manufacturer's headquarters does not mean that it was made there OR it may be made there but ingredients sourced from elsewhere. It has to meet FDA standards, regardless of where it is made.
I did find an article from a few years ago about the FDA recalling levothyroxine that was made in China, even though they said it caused no harm.
It's *synthetic* thyroid. The raw materials are grown in a lab. The lab can be anywhere in the world. Your prescription label has the company of manufacture for all generics. The manufacturer's website can probably provide the countries where they do the actual manufacturing of product.
Most generics are made by a myriad of manufactures and in fact, even the manufacturer of the brand name, can manufacture and sell a generic of the same drug (such as Sanofi selling a generic of their own Ambien). I've had levothyroxine from Dr. Reddy - which is in India. I've had it from companies that have mfg plants in a few other countries too (Dr. Reddy is just the one I remember, because they made the levo I was getting at Stop & Shop for five years before the store switched).
Depends. Often is made in Asia. Those made in the US could be made of foreign components. You can check where is made by looking at your prescription label.
E.g. Alvogen global operations includes four manufacturing facilities in the U.S., South-Korea and Taiwan.
It has to meet FDA standards, regardless of where it is made.
That's in theory. But they might or might not meet FDA standard in the long run.
The Agency is legally required to inspect manufacturing facilities in the US every two years but had no similar mandate for the inspection frequency of foreign facilities.
Some manufactures overseas were never inspected.
Just recently, with new resources, FDA has been able to inspect some facilities that previously had not been inspected. Catalog showed that as of December 2016, there were 963 foreign manufacturing facilities that had never been inspected by FDA.
All of the 963 foreign manufacturing facilities that GAO reported to be uninspected have now been addressed. By the end of 2019, FDA had inspected 496, or approximately 52% of these previously uninspected facilities.
FDA claims that it has now evaluated all previously “never inspected†facilities.
But it's hard to believe it's true.
The pandemic postponed almost all foreign inspections for most of 2020. And the number of these inspections had generally been declining since 2016—which FDA attributes in part to fewer investigators.
With no clear regulations and mandate for the inspection frequency of foreign facilities, who knows when those manufacturers will be inspected again, if ever.
Are they following FDA guidelines knowing how infrequent they get inspected?
Go figure... https://www.gao.gov/products/gao-22-103611
The FDA simply doesn't even know how much does U.S. rely on China for drugs. FDA data on U.S. reliance on foreign production of drugs are limited.
Janet Woodcock, FDA’s director of the Center for Drug Evaluation and Research, in congressional testimony in October 2019 said while it is clear drug production, particularly of APIs ( API = Active Pharmaceutical Ingredients means the active ingredient which is contained in medicine), has moved out of the U.S., the FDA doesn’t know a lot more than that.
The FDA doesn’t know whether Chinese facilities are actually producing APIs, how much they are producing, or where the APIs they are producing are being distributed worldwide, including in the United States. https://www.fiercepharma.com/manufac...y-doesn-t-know
FDA has the resources to inspect only a handful of foreign facilities, and physically examines less than 1% of shipments offered for import.
You trust FDA? I don't.
I've been taking the same dose of whatever generic the pharm is distributing for 25 yrs with no noticeable changes in symptoms or lab tests -- until this last routine, yearly check when my TSH rose from its usual low normal to a high normal value and a mild macrocycic anemia appeared-- typical of low thyroxine levels...??? significant change in bio-availability of the present generic I'm using?...Is quality of generic an issue?
More importantly in the long run-- will a foreign source of our meds become a secutity and supply chain issue, should political circumstances change?
The vast majority of all our generic drugs are manufactured in India and China, at the very least, the ingredients. Drug manufacturing in Puerto Rico, where the majority of US drugs were made, ceased in 1996/1997 thanks to the Small Business Act of 1996 where Congress took away the tax advantage of operating on the island throwing Puerto Rico into a deep depression due to loss of jobs which headed off shore. PR was littered with closed Pharma plants.
Thank you for all of your input. All drug manufacturing (both raw products and compilation) should be brought back to the USA.
Not going to happen. Most people already complain about the current prices of drugs, medications produced in the US would be insanely expensive and out of reach to even larger population.
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