Bayshore Announces Expedited Review of ANDA Submission

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Bayshore Receives FDA Acknowledgment and Confirmation of Expedited Review Status for Most Recent ANDA Submission

This acknowledgment from FDA of expedite review status of our recent ANDA submission represents our continued success in following the strategic plan we developed last year" says Bayshore's President, Mark Moshier

Bayshore Pharmaceuticals LLC ("Bayshore") is pleased to announce the acknowledgment from U.S. FDA of "expedited review" status for its most recent Abbreviated New Drug Application ("ANDA") submission. "This acknowledgment from FDA of expedited review status for our recent ANDA submission is yet another milestone for Bayshore and represents our continued success in following the strategic plan we developed for our Product Portfolio Selection Process last year. We are especially excited to be adding this product to our portfolio because not only may we be the sole generic player in the market, but there is a significant U.S. Government business opportunity we are targeting as well," says Mark Moshier, President of Bayshore. Bayshore currently has three (3) pending ANDA's, with a combined approximate retail market value of $38 million over the previous 12 month period, according to industry sales data.

In addition, Bayshore advises that is has now obtained all required state licenses and registrations to market and distribute its pharmaceutical products throughout the U.S.

About Bayshore Pharmaceuticals:
Bayshore Pharmaceuticals is a privately-held full service Pharmaceutical Sales & Marketing company founded in 2011 and based in Short Hills, NJ. Bayshore focuses on the generic prescription drug marketplace, developing and commercially manufacturing off-patent solid oral dose, semi-solid, ophthalmic and injectable products utilizing its global network of FDA-approved partners. The Bayshore label is fully-licensed, and via our strategic relationship with Granard Pharmaceutical Sales & Marketing, will provide access to all major trade distributors, wholesalers, retail pharmacy and mass merchandise chains and mail order outlets. All of Bayshore’s products and our respective partners fully recognize and comply with the highest quality standard, as per US-FDA requirements, and we emphasize the importance of project management to deliver on our commitments in a timely and reliable manner.

For Further Information, please contact:
Mark Moshier, President
Tel: 973-218-2683
mark(dot)moshier(at)bayshoreus(dot)com

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