FAIRFIELD, N.J. — Generic drug company Leading Pharma LLC has entered a multiyear development pact with specialty research-and-development company Carnegie Pharmaceuticals LLC.
Leading Pharma said Monday that under the agreement, Carnegie will exclusively develop and file more than two dozen Abbreviated New Drug Applications (ANDAs).
Leading Pharma is led by chief executive officer Ron Gold, the former president and founder of Rising Pharmaceuticals, and Rasik Gondalia, a co-founder of Core Pharma. Leading Pharma manufactures, develops, purchases, licenses and distributes high-quality products to drug chains, distributors, mass merchandisers, government agencies and managed care accounts nationwide. The company also operates a 53,000-square-foot manufacturing site, formerly Excellium Pharmaceuticals, in Fairfield, N.J.
“The partnership between Leading and Carnegie is a natural match,” Gold said in a statement. “Both companies are run by a team of sophisticated professionals with decades of experience who have the specialized know-how to develop, manufacture, launch and distribute some really exciting, hard-to-find, hard-to-develop niche products.”
Princeton, N.J.-based Carnegie Pharmaceuticals offers generic pharmaceutical companies assistance with product development, manufacturing, technology transfers and ANDA filings. The company is known for developing product portfolios by analyzing formulation barriers, market data, patents, regulatory hurdles and other factors to devise specialized product strategies, according to Leading Pharma.
“We have a highly trained team of professionals at Carnegie who don’t shy away from developing barrier-to-entry products that will have little or no competition,” stated Rakesh Grover, president and CEO of Carnegie and former president and chief operating officer of Sigmapharm Laboratories LLC. “Carnegie Pharmaceuticals is excited about the possibilities of this exclusive partnership with Leading Pharma because, like us, they are a dynamic new company led by industry veterans who have both the experience and the flexibility to work on products that are even beyond the comfort zone for some of the larger pharmaceutical companies.”
