Lannett Company Inc has signed an agreement with GlenMark Pharmaceuticals Inc USA, a subsidiary of GlenMark Pharmaceuticals Limited for the exclusive manufacture of a GlenMark product and distribution of additional GlenMark manufactured generic drug products. GlenMark Pharmaceuticals Limited is a leading research and development firm among the top 20 Indian pharmaceutical companies.
Under the terms of the agreement, Lannett will exclusively manufacture and distribute the first product and distribute four additional products, all upon approval by the U.S. Food and Drug Administration (FDA). The abbreviated New Drug Applications (ANDAs) will be submitted to the FDA by Lannett for GlenMark; and GlenMark will pay all research and development costs for the products. After GlenMark receives approval of the ANDAs, Lannett will launch its distribution of the products to its growing base of customers, including chain pharmacies, mail-order pharmacies, wholesalers and distributors, managed care, pharmacy benefit managers and buying groups. Since the Company has no control over the FDA review process, Lannett is unable to anticipate whether or when it will be able to begin commercially shipping the products.
According to Arthur P. Bedrosian, Lannett's President, "With this agreement, Lannett expects to further expand its line of quality generic products. We are excited about the opportunity to work with a top Indian firm in a joint venture like this." India has become one of the leading international countries for pharmaceutical development, including active pharmaceutical ingredient (API) manufacturing, research and development initiatives, and finished dosage manufacturing. Lannett anticipates further product development arrangements will be explored to enhance the Company's strategy for future growth.