First Rx Approved Product Manufactured in Bangladesh
SHORT HILLS, N.J.
Nov. 14, 2016 /PRNewswire/
In collaboration with Beximco Pharmaceuticals Ltd. (Dhaka, Bangladesh), Bayshore Pharmaceuticals announces that it has commercially launched Carvedilol tablets (3.125 mg, 6.25 mg, 12.5 mg, 25 mg). This launch represents the first prescription pharmaceutical product manufactured and approved in Bangladesh and was commemorated at a ceremony in Dhaka attended by the U.S. Ambassador to Bangladesh, Ms. Marcia Bernicat, as well as several key Ministers of the Bangladesh government and Beximco Pharma’s Executive Management team.
“This ANDA approval is a milestone event for Beximco and the entire Bangladesh pharmaceutical industry, and Bayshore is proud to be working with Beximco as its Sales & Marketing partner,” said Mark Moshier, President of Bayshore. “The product will be commercialized under the Bayshore label. Additional approvals and product launches from our collaboration are imminent and we look forward to introducing the US generic market to the capabilities of Beximco Pharma and Bangladesh.”
The Managing Director of Beximco Pharma Mr. Nazmul Hassan MP, said, “As a leading manufacturer and exporter of medicine in the country, we always strive to capitalize on the opportunities in global generics. We believe our foray into the world’s largest pharma market will give us the impetus to strengthen our international presence, especially in the regulated markets for value added generics.”
Based on industry sales data, the product has reported U.S. sales of approximately $73 million over the previous 12-month period.
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. All of Bayshore’s products and our respective manufacturing 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.
About Beximco Pharmaceuticals Limited:
Founded in 1976 and based in Dhaka, Bangladesh, Beximco Pharma manufactures and sells generic pharmaceutical formulation products and active pharmaceutical ingredients. The Company also undertakes contract manufacturing for multinational and leading global generic pharmaceutical companies. The Company has manufacturing facilities for producing various delivery systems such as tablets, capsules, liquids, semi-solids, intravenous fluids, metered dose inhalers, dry powder inhalers, sterile ophthalmic drops, prefilled syringes, injectables, nebulizer solutions, oral soluble films etc. Ensuring access to quality medicines is the powerful aspiration that motivates 3,000 employees of the Company. Beximco Pharma′s state-of-the-art manufacturing facilities are certified by global regulatory authorities of the US, Europe, Australia, Canada, GCC and Latin America, among others.
Bayshore is proud to announce its relationship with Navipharm Pvt Ltd (Hyderabad, India). Navipharm will be responsible for local (India) Project Management and Sourcing/Business Development activities. Please contact Mr. P.S Rao and/or Mr. GRS Raghavan for more information.
Navipharm Pvt Ltd
The Platina, Gachibowli, Hyderabad
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 & 5mg 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.
Bayshore Pharmaceuticals 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.