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Minimizing Time to Market: Developing Consumer Health Products Under the US OTC Drug Monograph

26 January 2012 by Aptalis Pharmaceutical Technologies

With the tightening of R&D budgets and increased pressure from financial stakeholders, the pharmaceutical industry faces a great challenge in bringing profitable drug products to market both quickly and efficiently. By choosing to develop new and patient-friendly dosage forms of products conforming to an existing OTC Drug Monograph, companies may be able to reduce the time and cost involved in taking a new product to market. This white paper discusses how the OTC Drug Monograph guidelines work, using UnisomĀ® Sleepmeltsā„¢ as a case study to illustrate how innovation and creativity can be used to maximize resources while minimizing time to market.

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