ADRM-010A
Product Description
CPC Scientific.Inc
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US
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2015On CPHI since
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500 - 999Employees
Company types
Categories
Specifications
CPC Scientific.Inc
-
US
-
2015On CPHI since
-
500 - 999Employees
Company types
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CPC Scientific.Inc resources (1)
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News Terlipressin Formulation with API Manufactured by CPC Scientific Approved for Further Study by the MEB
SAN JOSE, CA., Feb 1, 2021 /CPCNewswire/ — 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.
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