The FDA has completed a successful pre-approval inspection (PAI) of Tapemark’s manufacturing process and a general good manufacturing practices (GMP) inspection. The pre-approval inspection assessed Tapemark’s readiness to commercially manufacture one of its customer’s transdermal pharmaceutical products that is awaiting FDA approval. The FDA thoroughly reviewed Tapemark’s facilities for compliance with its procedures and adherence to GMP. “This successful PAI and GMP inspection represents another major success in the achievement of our CDMO strategic goals that includes full-service pharmaceutical commercial product manufacturing,” said Andy Rensink, President and COO of Tapemark. “We extend our appreciation and congratulations to all of our employees and contractors on this outstanding accomplishment.”
Tapemark is a world leading contract developer and manufacturer of drug delivery systems with a focus on transdermal patches and oral thin films, serving the pharmaceutical and medical device markets. Whether companies are launching new products, or need life cycle management and patent extensions of existing ones, Tapemark provides the strategic guidance and manufacturing capabilities to help customers realize the breadth of optimal and alternative drug delivery formats.