Terlipressin Formulation with API Manufactured by CPC Scientific Approved for Further Study by the MEB
The Californer/10118741

SAN JOSE, Calif. - Californer -- CPC Scientific Inc. is pleased to announce that the Dutch Medicines Evaluation Board (MEB) has completed its technical review of their client's drug product and formulation process for Terlipressin. The API provided to the client is manufactured at CPC Scientific's GMP facility. On January 18, 2021, the MEB granted approval of the drug product and will move to the next phase to review product characterization profiles, specifications, and labels in the Netherlands. The MEB is the Dutch regulatory agency responsible for assessing, monitoring, and promoting the proper use of medicines. After final approval, the drug product will be available for sale in the Netherlands and Germany.

Comment from Shawn Lee, CEO and Founder of CPC Scientific Inc.

"We are thrilled with the outcome MEB's technical review of our terlipressin API being used in our partner's drug product. We are hopeful that this approval will lead to increased patient access to terlipressin in the Netherlands and Germany."

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Terlipressin, chemically known as triglycyl lysine vasopressin, is a synthetic long-acting vasopressin used for the emergency treatment of acute bleeding of esophageal varices and type 1 hepatorenal syndrome (characterized by spontaneous acute renal insufficiency) with severe cirrhosis of the liver and ascites. Terlipressin injection was first approved on September 23, 2010 in Europe a commercial product for use in Germany, the Netherlands, the United Kingdom, Spain and Italy. Current License holders for terlipressin include Ferring Pharmaceuticals (trade name Glypressin) and New Medicon Pharma (trade name Teripress).

About CPC Scientific Inc.

Founded in 2001, CPC Scientific is a globally recognized and leading CDMO specializing in synthetic peptide production. The company works directly with leaders in the biotechnology and pharmaceutical industries to help bring life-changing therapeutics and diagnostics to market. They boast the largest research peptide facility in the world, which successfully has undergone multiple FDA inspections and audits by global pharma organizations. CPC Scientific has the capability of serving customers from early drug discovery stages through clinical trials to commercial manufacturing. We provide milligram to multi-kilogram quantities of CGMP and research-grade peptides with purities of up to 99%. With their emphasis on technology, innovation, and experience, we are proud to have a US FDA inspected GMP facility, ISO 9001, and ISO 13485 certification, a claim few companies in the world can make.

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Inquiries:

CPC Scientific Inc.
Dr. Chris Gothard +1-408-734-3800 (San Jose, CA)
EMAIL: chris@cpcscientifc.com