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Signifies growth of 505(b)(2) approval pathway
February 4, 2015
By: Kristin Brooks
Managing Editor, Contract Pharma
Camargo Pharmaceutical Services will launch its new brand at the Generic Pharmaceutical Association (GPhA) Annual Meeting. The new brand relates to the company’s 505(b)(2) approval pathway for companies looking to reposition existing products or expand portfolios with differentiated products. “The number of 505(b)(2) approvals has increased steadily in the past few years, and is more relevant than ever given current market constraints, such as the generics cliff,” said Ken Phelps, president and chief executive officer of Camargo. “To date, our team has guided more than 200 FDA approvals and now leads the largest percentage of 505(b)(2) submissions of any team submitting to the FDA. The new brand encapsulates what we do best: identify and develop viable products.” In addition to the brand launch, the company will be discussing the recently organized 505(b)(2) Forum, of which Camargo is a founding member. The Forum was organized by product developers and service providers interested in improving best practices across the 505(b)(2) development process.
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