Bayshore Announces US FDA Approval of First ANDA

Share Article

Bayshore Pharmaceuticals announces final US FDA approval of Methscopolamine Bromide tablets has been granted September 24, 2012

"...the first ANDA approval is a milestone event and Bayshore is thrilled to have achieved this accomplishment" says Mark Moshier, President of Bayshore

Bayshore Pharmaceuticals has announced that the U.S. Food & Drug Administration (FDA) has granted final approval for their Abbreviated New Drug Application (ANDA) for Methscopolamine Bromide tablets (2.5 & 5 mg tablets). Methscopolamine Br is available by prescription only and indicated for adjunctive therapy for the treatment of peptic ulcers. The product is the generic equivalent of Fougera's 2.5 mg Pamine® and 5 mg Pamine Forte®

"Needless to say, the first ANDA approval for any generic pharmaceutical company is a milestone event and Bayshore is thrilled to have achieved this accomplishment. We are now focusing on preparing for its commercial launch and fulfilling the expectations and requirements of our customers" says Mark Moshier, President of Bayshore.

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

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Mark Moshier
Visit website