Product/Composition:- | Dulaglutide Injection |
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Strength:- | 0.75 mg/0.5 mL,1.5 mg/0.5 mL, 3.0 mg/0.5 mL, 4.5 mg/0.5 mL |
Form:- | Prefilled Pens |
Reference Brands:- | Trulicity®(US & EU) |
MOQ | As per the manufacturer batch size |
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Dulaglutide is a GLP-1 receptor agonist that enhances glucose-dependent insulin secretion, suppresses glucagon, and slows gastric emptying. Benefits include improved glycemic control in type 2 diabetes, weight reduction, and cardiovascular risk reduction in high-risk patients. Administered once weekly for convenience.
Dulaglutide is manufactured under cGMP (FDA) and GMP (EMA) standards, ensuring quality across production. The FDA approves Trulicity® for T2DM with cardiovascular risk reduction, requiring post-marketing safety monitoring (e.g., pancreatitis, thyroid C-cell tumors). The EMA mandates similar vigilance, including risk minimization for medullary thyroid carcinoma. Both agencies require sterile manufacturing, stability testing (refrigerated storage; 14-day room-temperature stability post-opening), and batch traceability. FDA’s REMS is not required, but EMA emphasizes patient education on injection techniques. Non-compliance risks include regulatory actions (warning letters, recalls). For compliant global sourcing, refer PharmaTradz.com.