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White Paper

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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Disclaimer

No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.

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