Mirabegron

Overview

Mirabegron is a beta-3 adrenergic agonist used for the treatment of overactive bladder. It works by relaxing the detrusor muscle in the bladder, increasing its storage capacity.

API suppliers (31)

Suppliers of Mirabegron evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.

• SOLARA ACTIVE PHARMA SCIENCES LTDIndia1 active DMF GMP on record
• Micro Labs Usa1 active DMF
• Zhejiang Huahai Pharmaceutical Co., Ltd.China1 active DMF GMP on record
• ALIVUS LIFE SCIENCES LTDIndia1 active DMF GMP on record
• APITORIA PHARMA PRIVATE LTDIndia1 active DMF GMP on record
• Zydus Lifesciences LimitedIndia1 active DMF GMP on record
• SynthonNetherlands1 active DMF GMP on record
• Jiangxi Synergy Pharmaceutical Co., LtdChina1 active DMF
• DELMAR CHEMICALS INCCanada1 active DMF
• Piramal Pharma LimitedIndia1 active DMF GMP on record
• Unichem Laboratories Ltd.India1 active DMF GMP on record
• JUBILANT BIOSYS LTDIndia1 active DMF
• COHANCE LIFESCIENCES LTDIndia1 active DMF GMP on record
• Biocon LimitedIndia1 active DMF
• Viwit Pharmaceutical Co., Ltd.China1 active DMF
• Cipla USA, Inc.USA1 active DMF
• Hubei Gedian Humanwell Pharmaceutical Co. LtdChina1 active DMF GMP on record
• Zhejiang Huayi Pharmaceutical Co., Ltd.China1 active DMF
• CHEMO SMS ENTERPRISE SLSpain1 active DMF
• Neuland Laboratories LimitedIndia1 active DMF
• AMI LIFESCIENCES PRIVATE LTDIndia1 active DMF GMP on record
• AMOLI ORGANICS PVT LTD1 active DMF
• Macleods Pharmaceuticals Ltd.India1 active DMF GMP on record
• SYNTHIMED LABS PRIVATE LIMITEDIndia1 active DMF GMP on record
• RAKSHIT DRUGS PRIVATE LTD1 active DMF

Showing 25 of 31 suppliers — see the full list in the app.

EU CEP holders (15)

Companies holding a valid EU Certificate of Suitability (CEP) for Mirabegron, from the EDQM certification database. A CEP holder is a documented EU-market source of the substance — not necessarily the manufacturer — and these are not yet profiled in our directory.

Patent & exclusivity (US)

Per the FDA Orange Book (16 approved US products), the latest listed US patent on Mirabegron expires 30 Sept 2036. Generic API sourcing typically opens up once these lapse.

Therapeutic areas