The pharmacy tech at the drugstore handed me yet another drug refill and warned me that the drugs came from two different manufacturers – not an unusual warning. So that started me to wondering — Where were my drugs coming from? Do I have backup manufacturers?
I wrote a post in 2015 about my drug (at the time) coming from India, a country that has never inspired me as the epitome of hygiene and quality control. The company was Dr. Reddy’s Labs Ltd. Turns out the company is the ninth largest generic pharmaceutical company in the world. (What a great marketing slogan they could come up with – “Need relief? We’re Reddy!”)
So where were my drugs coming from now? India again? Puerto Rico used to be a hotbed of pharmaceutical manufacturing (due to tax breaks) but after Hurricane Maria which devastated Puerto Rico in 2017, I was not sure if that was still the case.
You would think it would be a simple matter to find out where your drugs are manufactured – you just look at the package, right? I just got a shingles vaccine and the box very clearly says: Manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium, Antigen and Adjuvant Made in Belgium.
Not so straightforward with my Parky drugs. First up, Ropinirole ER. I was disturbed to find out that GlaxoSmithKline had just made a “business decision” to stop making Requip, the branded version of Ropinirole. But the company was going to continue to make Requip XL, the branded version of Ropinirole ER. (ER stands for Extended Release which means I only need to take one a day.) So I guess I was OK – especially since I always get the cheaper generics anyway.
Where are the generic Ropinirole ER pills made? The manufacturer on the pill bottles I was sold was Trigen Laboratories. I looked it up on the Internet, and found it was HQ’ed in New Jersey – but it wasn’t clear from their barebones website whether that’s where they manufactured the drugs. Peeling back the prescription label, I found the tiny print that said “Made in India. Manufactured for Trigen Laboratories LLC, Bridgewater, NJ.” India is a big place – no clue on Trigen’s website (or that of their parent company, Osmotica). I suspect we are back to Dr. Reddy’s, as it is on the list of six manufacturers of FDA-approved generic Ropinirole ER. Interestingly, this list does not include Trigen.
Whew – moving on to the second drug: Carbidopa/Levodopa, brand name is Sinemet. My drugstore had dispensed these drugs into their own pill bottles, so I had no original bottle to examine. The two manufacturers noted by the drugstore were Mylan and Actavis . One cheery note about Mylan is that it is the largest generic drug manufacturer in the world – and (with other pharmaceutical companies) is being sued for colluding to fix prices on generic drugs. Mylan is also the company that attempted to price gouge Epi-Pens in 2016. A thorough review of Mylan’s website does not tell you where my pills are manufactured, only this unrevealing sentence: “We have a manufacturing and R&D footprint that extends across four states plus Puerto Rico.” Since Mylan has a presence in 36 other countries, my pills could be manufactured in Slovakia or South Africa, to name a few.
And what about Actavis? Turns out Actavis was acquired by Teva Pharmaceuticals in 2016, one of several Big Pharma companies being sued for marketing of opioids. (Teva just settled for $85 million.) I decided to talk to a human at what is now called Teva Actavis. I called up their customer service department and got a nice lady in their medical department. She said the drugs were manufactured in the United States, but refused to tell me (or didn’t know) where specifically because the location was “subject to change”. Considering how tightly the FDA regulates drug manufacturing, a company does not casually change its location.
And why does it matter where my drugs are manufactured? One of the news articles I came across had the reassuring headline: “FDA flags manufacturing shortcomings at Actavis plant”. Doesn’t give me a warm fuzzy….