MSD has warned regulators to expect a shortage of its Parkinson’s medicine, Sinemet, due to production constraints at a contract manufacturer’s facility.
MSD (known as Merck & Co. in North America) informed regulatory health agencies in several countries that shortage of two products, Sinemet Plus (25/100) and Sinemet 25/250, are expected from autumn 2018 through to spring, 2019.
MSD outsources the manufacture of Sinemet (carbidopa-levodopa) to an unnamed contract manufacturing organisation (CMO) but packages the drug itself.
According to MSD, supply constraints, coupled with a reduced demand for generic versions of Parkinson’s disease medicines, have prompted the global shortage.
“The manufacturer has recently experienced manufacturing-related delays,” MSD told us an emailed statement.
“Historically, generic manufacturers have supplied most of the levodopa, and MSD has provided a small amount of the medicine to the market. Recently, however, supply of this medicine from generic manufacturers has declined, and MSD has received an increase in orders for the product, far exceeding our forecast,” the firm added.
MSD expects the shortage to continue until Q1, 2019, but is “working to resolve this situation as quickly as possible”, we were told.
Parkinson’s UK’s head of policy and campaigning told us, “This shortage is worrying and we are continuing to work closely with MSD on informing the Parkinson’s community, including healthcare professionals, about it.”
“We are encouraging people with Parkinson’s who are affected to speak to their consultant, Parkinson’s nurse or GP about potential alternatives to the drugs they are currently on. For instance, a generic, non-branded version of Sinemet might be suitable and more readily available,” she added.
https://www.in-pharmatechnologist.com/Article/2018/10/01/Delays-at-MSD-s-CMO-prompt-Sinemet-shortage
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