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The US generic market is large and growing. The market is complex and fragmented, requiring a variety of infrastructures to reach all major channels and segments. This is usually a difficult process for all except the few big pharmaceutical players. Nivagen has exceptional market access and is looking to in-license products from pharmaceutical companies whose products are either already FDA approved, or are in the developmental stage and in need of Nivagen’s expertise to launch into the US market.

Possible Frameworks for Acquisitions and In-licensing:

CROs

If you have formulations ready, Nivagen can provide market research on potential market size and the competitive environment. Nivagen can acquire your formulation, do the BE study, FDA submission and then commercialize the product. If you have ANDAs ready to go, Nivagen is always actively looking to acquire and launch new products.

CRAMs

If your formulation is ready for FDA filing, we can provide regulatory assistance and commercialize the product for you. We can efficiently manage the FDA approval process and shorten the time to launch new products. We are open to each and every possible arrangement.