SCALE-UP MANUFACTURING

Transdermal may dramatically reduce the time to market for a particular compound. Average time for patch approval is 4 years.

Transdermal Specialties is offering R&D services to those firms who desire a faster pathway to FDA approval, from as long as 12 years of drug development to as little as 4 years through a transdermal pathway. The new transdermal Laboratory is designed to develop new applications for ultrasonic transdermal drug delivery. Already the company is working upon a Parkinson’s Patch, a Patch for Multiple Sclerosis, and a Migraine patch. Through a series of Research Collaborations, the company is expanding the number of drugs which can be delivered via U-STRIPTM technology from the 20 or so products currently on the market, to over 175 pharmaceutical preparations on the Company’s target list.

COMMERCIAL MANUFACTURING

To guarantee your product meets global compliance standards, our commercial manufacturing process combines extensive knowledge of device and drug quality systems requirements with pharmaceutical manufacturing expertise, including:


PATCH PRODUCTION CAPACITY: 1MM UNIT/MONTH


Establishing a quality agreement with client


Maintaining process performance


Assuring continued compliance with ever-evolving regulatory standards


Managing supply chain with respect to API, component sourcing, and packaging



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