U.S. FDA Requirements: Insulin Glargine Recombinant
Pharmaceutical / Drug Definition :
Promotes glucose transport, which stimulates carbohydrate metabolism in skeletal and cardiac muscle and adipose tissue. Also promotes phosphorylation of glucose in liver, where it's converted to glycogen. Directly affects fat and protein metabolism, stimulates protein synthesis, inhibits release of free fatty acids, and indirectly decreases phosphate and potassium.
In the United States, Insulin Glargine Recombinant is regulated by the U.S. Food and Drug Administration (FDA). FDA has specific requirements regarding the registration and listing of Insulin Glargine Recombinant.
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U.S. FDA Regulations:
U.S. FDA Regulation: 21 C.F.R. Part 207
Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.