Suppliers and packagers for MYRBETRIQ GRANULES

MYRBETRIQ GRANULES

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apgdi	MYRBETRIQ GRANULES	mirabegron	FOR SUSPENSION, EXTENDED RELEASE;ORAL	213801	NDA	Astellas Pharma US, Inc.	0469-5020-99	1 BOTTLE in 1 CARTON (0469-5020-99) / 100 mL in 1 BOTTLE	2021-03-25

Suppliers and packagers for MYRBETRIQ GRANULES

Last updated: June 1, 2026

Myrbetriq Granules Suppliers: Who Manufactures and Supplies the Drug Product and API Across the Supply Chain

Executive summary: Suppliers for MYRBETRIQ granules (mirabegron oral granules) are concentrated in the contract manufacturing and API supply chain for the mirabegron drug substance and the finished dosage form sold under the MYRBETRIQ brand. Myrbetriq is marketed in the US by Astellas Pharma US, Inc.; production and packaging supply are typically handled by contract manufacturers named on regulatory filings and labeling. To identify the exact current supplier roster (site-level drug-product manufacturing and labeled packager, plus API suppliers), the Orange Book, FDA labeling manufacturing sections, and the underlying chemistry, manufacturing, and controls (CMC) cross-references must be mapped to the relevant application (NDA) and manufacturing changes. No complete, accurate supplier list can be produced from the information provided here.