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Tech Sheet – Mirabegron API

Tech Sheet – Mirabegron API

CAS no. 223673-61-8

Mirabegron is a ß-3 adrenergic receptor agonist and a widely prescribed oral drug for treating overactive bladder (OAB). The drug improves symptoms associated with OAB, such as urinary urgency or urgency incontinence.

Mirabegron was approved under the trade names Myrbetriq (US, 2012), Betmiga (Europe, 2012), and Betanis (Japan, 2011). As of July 2023, Mirabegron is approved in 60 countries worldwide for OAB indications.

Dr. Reddy's API Offering

  • We manufacture Mirabegron at our cGMP API manufacturing facility (CTO-6, Vizag), which is successfully inspected by international regulatory authorities such as the USFDA, EMEA, ANVISA, PMDA and Health Canada.
  • We offer Alpha Form-1 (same as the originator).
  • API quality complies with most Stringent European Pharmacopoeia 11.2 monograph specifications.
  • Employing a Quality by Design approach for efficient processes and high-quality output.
  • Developing an atom-efficient process to minimise process waste.
  • Effective control strategy for avoiding potential genotoxic and carcinogenic impurities.
  • Assured process safety and scalability.

To learn more about our API offerings, please read the tech sheet on Mirabegron API by filling out the contact form below.

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免责声明

本目錄中的任何信息(包括對任何產品或服務的任何引用)均不構成銷售要約,或被解釋為代表銷售要約。受有效專利保護的產品不提供或供應用於商業用途。但是,只要存在此類監管豁免,就可以出於監管提交的目的提供此類產品的研究數量。買方應對各自市場的專利方案進行獨立評估,並承擔所有與專利相關的責任。在印度受有效專利保護的產品不可用於商業用途,但可用於第 107A 節。

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