Dulaglutide Injection

Form: Prefilled Pens

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

Reference Brands: Trulicity®(US & EU)

Category: Diabetes

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.