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Tapemark Passes Regulatory Hurdle

Manufacturing facility completes successful FDA pre-approval and general GMP inspection

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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 an...

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