Amneal, Indoco partner on ophthalmic products

Drug Store News,  Nov 12, 2007  

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PATERSON, N.J. -- Amneal Pharmaceuticals and Indoco Remedies have finalized a joint venture partnership to develop, manufacture, market and distribute several products. The agreement will lead to an initial pipeline of at least 10 ophthalmic products, several of which have progressed extensively through the development process.

Amneal's role in the partnership is to prepare and file drug applications to the Food and Drug Administration for approval, maintaining FDA and regulatory agency documentation, as well as to exclusively sell, market and distribute these products throughout the U.S. market.

Indoco's responsibilities within the joint venture are active pharmaceutical ingredient manufacturing for the majority of these products, formulation and analytical method development, production of bioequivalence batches, data reporting and ultimately manufacturing the approved generic drugs.

The companies plan on having the 10 products hit the market within the next five years. Product selection initially will be done by three members of each company to build a balanced offering in ophthalmics. Both companies will share funding for these products, as well as financial benefits equally.

The two also have begun to identify several more ophthalmic products to pursue, as well as other therapeutic categories and dosage forms. They both expect this agreement to expand significantly in the near term and to last many years.

This agreement will help Indoco in the U.S. market. Amneal gives Indoco a growing generic company to market its products, according to Suresh Kare, chairman and managing director of Indoco Remedies, in a statement.

"In Amneal we now have a young and growing generic company as a partner to market our ophthalmic products in the United States," Kare said. "This partnership will help us to speedily introduce these products to the U.S. market and explore other growth opportunities in the largest generic market in the world."

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