PATERSON, N.J., Oct. 23 /PRNewswire/ -- Amneal Pharmaceuticals, a New Jersey-based developer, manufacturer and distributor of generic pharmaceuticals and Indoco Remedies, an India-based API and finished dosages development and manufacturing company announce the finalization of a joint venture partnership to develop, manufacture, market and distribute several products for the United States market. The initial product pipeline will include at least ten ophthalmic products, several of which have already progressed substantially through the development process.
Under terms of this agreement, the combined expertise of the two companies creates a highly efficient product flow from API manufacturing through regulatory approval and distribution that will bring at least ten high-quality generic drugs to the US market over the next five years. Product selection, done by three members of each company, chose the initial group of products to build a balanced offering in the ophthalmic category, providing potential customers a single source for the most important molecules of the category.
Amneal's role in the partnership is to prepare and file ANDAs for US FDA approval via eCTD/QBR/QOS process, maintaining FDA and regulatory agency documentation as well as to exclusively sell, market and distribute these products throughout the US pharmaceutical market.
"We are excited to complete this agreement and begin our long term, collaborative relationship by launching a strong group of products with a company that has proven expertise and commitment to producing the highest quality pharmaceuticals," shared Chirag Patel, Amneal Pharmaceuticals' president.
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.
"In Amneal we now have a young and g
|SOURCE Amneal Pharmaceuticals|
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