ambiopharm

  • sam patrick posted an article
    Market is currently valued at $770 million see more

    Upsher-Smith Laboratories, LLC (Upsher-Smith) and AmbioPharm, Inc. (AmbioPharm) today announced that the companies have entered into a partnership agreement to develop and market Corticotropin Injection in the U.S. The market for adrenocorticotropic hormone or ACTH (brand Acthar® Gel*) is currently valued at $770 million (IQVIA, 12 months ending June 2020).

    Under the terms of the agreement, Upsher-Smith will submit the New Drug Application for Corticotropin Injection to the U.S. Food and Drug Administration (FDA) and market and distribute it under its own label in the U.S. upon FDA approval. AmbioPharm will manufacture the active pharmaceutical ingredient exclusively for Upsher-Smith. A contract manufacturing organization will exclusively supply Upsher-Smith with the finished product for sale in the United States. Financial terms related to the deal have not been disclosed.

    “We are excited to partner with AmbioPharm, a leader in the field of peptide development and manufacturing, to bring Corticotropin Injection to the U.S. market,” said Rusty Field, President and CEO of Upsher-Smith. “This agreement represents another step in Upsher-Smith’s and Sawai’s strategy to co-invest in highly complex generics and 505(b)(2) products that can drive long-term growth.”

    Added Chris Bai, CEO of AmbioPharm, “We are pleased to bring our unsurpassed technical capabilities and peptide manufacturing capacity to our partnership with Upsher-Smith, a company with a long-standing tradition of bringing high-quality products to the patients who rely upon them.”

    About Upsher-Smith

    Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. Since 1919, it has brought generics and brands to a wide array of customers backed by an attentive level of service, strong industry relationships, and dedication to uninterrupted supply.

    As Upsher-Smith begins its second century in business, the company enters a new ambitious era that has been accelerated by its 2017 acquisition by Sawai Pharmaceutical Co., Ltd. Upsher-Smith and Sawai plan to leverage each other for growth worldwide and embark on an exciting new chapter as they seek to deliver the best value for their stakeholders, and most importantly, Do More Good™ for the patients they serve. For more information, visit www.upsher-smith.com.

    About AmbioPharm

    AmbioPharm, Inc. is a full-service peptide manufacturing company headquartered at its North Augusta, South Carolina, USA cGMP production site. Its second cGMP facility in Shanghai, China, performs process development and optimization and manufactures building blocks, raw materials, and custom peptides at a very large scale. Both of its cGMP facilities are capable of handling any manufacturing scale required to produce bulk peptides to custom specifications using a wide range of skill sets in both solid and solution-phase chemistry. Its management team has over 120 years of cumulative experience running a pilot to commercial-scale production. The Company also performs organic conjugations to small molecules, proteins, toxoids, antifungals, KLH, and PEG. For more information, visit www.ambiopharm.com.

    https://www.upsher-smith.com/news/upsher-smith-and-ambiopharm-announce-partnership-agreement-to-develop-and-market-corticotropin-injection/

  • sam patrick posted an article
    Company opens new manufacturing, quality control facilities see more

    Compliments of MidlandsBiz

    AmbioPharm Inc. a leading supplier of peptide active pharmaceutical ingredients has recently opened its new manufacturing and quality control facilities at its headquarters in South Carolina.

    “The new buildings were completed in April and qualified by May 15, 2020 expanding our peptide manufacturing capacity,” stated Dr. Chris J. Bai, CEO. “The new buildings add nearly 56,000 sq. ft of production space to our current footprint in South Carolina. In the near future, our subsidiary site in Shanghai will also complete a new campus of 350,000 sq. ft. later this year.”

    “As the world battles the Covid-19 pandemic, it has become increasingly apparent that no single solution will suffice for patients who are fighting the disease. Peptide approaches have been recently advanced for potential vaccine development, diagnostic testing and as therapeutic agents to help ameliorate the cytokine storm,” stated Dr. Michael W. Pennington, CSO. “Furthermore, we believe that science will prove to be the Achilles’ heel of the virus, and the world will recover more quickly as better therapies become available,” added Dr. Pennington.

    AmbioPharm Inc. is uniquely positioned to help companies that are developing peptide-based approaches targeting the virus. As the company with the world’s largest cGMP peptide manufacturing capacity, AmbioPharm Inc. has a very unique business model which helps us to produce peptides of both high quality and purity with very economical cost. AmbioPharm Inc. can be contacted through our website if you have a project which requires our services.