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Dawah Pharmaceuticals is Gearing Up to Enter the US Market

New York, NY – The global pharmaceutical market is estimated to be valued at $1.5 trillion by 2020 and witnessing a growth of 4-5%. In the last 3 decades, the pharmaceutical market witnessed a shift from a blockbuster model to new business models owing to the influx of generic drugs. Generics basically mimic the original drug characteristics and show equivalence in therapeutic effect. However, these class of drugs are cheaper and are easy to scale up when compared to original branded drugs. This change in the business model is attributed to the formulation of the Hatchmann-Wax act in 1984 as a federal law that encouraged the manufacture and sale of generic versions of the original branded drugs. The act provided some exclusivity rights to the original branded drug developers and generic manufacturers to file their application for abbreviated new drug applications (ANDA).

This increased competitiveness in the industry and provided avenues for patient populations who have limited access to medicines. Because of this, an original branded drug that lost its exclusivity rights becomes a target of a generic manufacturer to scale up a generic version and reduce the market share of the original drugs. Therefore, patent expiry rates have key drivers of generic drug development, manufacture, and marketing.

For Example, two companies, Camber and Amneal Pharmaceuticals, started just like Dawah. Camber was founded six years ago with four people and four laptops crammed into two small offices. Today, Camber boasts 80+ associates, 85,000sq.ft. of warehouse space, sales of over a billion and a half dollars, and is one of the fastest-growing generics companies in the US. Amneal was founded by two brothers and grew organically and through M&A became one of the leading US generic pharmaceutical companies.

Dawah Pharmaceuticals has aimed to take advantage of this market, in a more specific sector, sterile injectables. Dawah is gearing up to enter the US Market. Three drugs are close to completion — all sterile injectables. They will enter the market by 4Q2020. The batch review process has already started, as well as the FDA submission process.

Dawah has moved at unprecedented speed. Within two years, Dawah has identified and started the manufacturing process of three drugs, with seven more to come. Dawah has also engaged with a Third Party Logistics (3PL) organization to handle licensing and distribution of the manufactured products.

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Dawah Pharmaceuticals Updates | December 2019

Our contracted CMO has successfully completed the scale-up batch on the product. The three exhibit batches are scheduled for the next 3 weeks. This means that we are on target to file our ANDA with th


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