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news.New Jersey-based Amneal Pharmaceuticals and India-based Indoco Remedies have finalized a joint venture partnership to develop, manufacture, market and distribute several products for the US market.
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As per the 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 10 high-quality generic drugs to the US market over the next five years.
Amneal’s role in the partnership is to prepare and file ANDAs for FDA approval through 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.
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.
Suresh Kare, chairman and managing director of Indoco Remedies, said: “In Amneal we now have a young and growing generic company as a partner to market our ophthalmic products in the US. This partnership will help us to speedily introduce these products to the US market and explore other growth opportunities in the largest generic market of the world.”