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 API 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 these 10 products hit the market within the next five years. Product selection will be initially done by three members of each company to build a balanced offering in ophthalmics. Funding for these products, as well as financial benefits will be shared equally by both companies.