Transdermal patch manufacturer ProSolus doubles capacity with Texas facility

ProSolus, which already has a transdermal patch manufacturing facility in Florida, has opened a larger plant in Texas.

San Antonio-based Mission Pharmacal bought transdermal patchmaker ProSolus Pharmaceuticals two years ago and has now more than doubled its capacity with a second patch manufacturing facility in Texas.

The company said that it has opened a new plant at its Boerne, Texas, manufacturing site. ProSolus already has a manufacturing operation in Miami, where it is headquartered, but Mission said the new Texas operation has a larger production line. Combined, the company now has the ability to produce up to 100 million patches a year.

Privately-held Mission Pharmacal, which also owns generic drugmaker Alamo Pharma Services, did not disclose its investment in the new facility.

Executives said the new facility offers the company more options.

“For us, it’s all about the convenience and wearability of patches—creating more desirable, smaller sizes that stay in place while working effectively,” Juan Mantelle, ProSolus chief scientific officer, said in a statement. “We are consistently searching for new and better ways to bring transdermal products to market.”

The company pointed out that when manufactured and administered well, transdermals offer benefits not found in other drug delivery systems.

But the “manufactured well” part of the equation has tripped up some patch makers. Last year the FDA issued a warning letter to Noven, a subsidiary of Japan-based Hisamitsu Pharmaceuticals, for lapses at its Miami manufacturing facility.

Noven in 2015 recalled tens of thousands of boxes of its Daytrana ADHD patches from the market because of issues over peeling away a protective liner, a recall that resulted in a shortage of the patches.

In December, the FDA issued a warning letter to North Carolina-based Pocono Coated Products, a maker of transdermal patches—as well as construction flashing tapes and a custom coating system for body armor. The FDA cited the operation for poor product testing which resulted in it releasing patches that were subpotent.