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mirabegron Tablets, extended release (ER) 25 mg, 50 mg

Dossier type
US CTD
Dossier status
Under development
Country of origin
Bangladesh
GMP approvals
FDA
Comments
Exhibit batch planned for Aug’24 Pilot BE passed
Manufacturer #21891

Established in 1993, this manufacturer is an esteemed CTD dossier owner and manufacturer based in Bangladesh. As a GMP manufacturer, it specializes in pharmaceuticals and animal health products, adhering to strict GMP standards. This CTD dossier owner and manufacturer distributes its products in 24 countries, utilizing advanced production facilities that highlight its role as a leading GMP manufacturer and CTD dossier owner and manufacturer.

Mirabegron

Mirabegron treats overactive bladder. In this condition, the patient’s bladder muscles contract uncontrollably. This leads to frequent urination, urgent need to urinate, and inability to control urination. It can be used as a standalone therapy or in combination with Solifenacin. It has properties similar to antimuscarinic medication like Solifenacin. Its actions activate β3 adrenergic receptor in the bladder, leading to its relaxation. Mirabegron is sold under the brand name Myrbetriq among others. Astellas Pharma Inc. received the First approval for selling in the USA and EU in 2012. In 2017, with more than three million prescriptions, it was in the top 200 most prescribed drugs in the USA.

Dosage Forms & Strengths

Mirabegron is sold as an extended-release tablet in 25mg and 50mg strengths. In the treatment of overactive Bladder, as a Monotherapy, with symptoms of urge urinary incontinence, urgency, and urinary frequency, the dose is 25 mg, per day and it is typically effective within 2 months from the start of the therapy, the dosage can be increased to 50 mg a day dependent on individual efficacy and tolerance.

The price of Mirabegron

In the USA, the consumer has to pay an average retail price of $497.10 for 30 branded tablets. This medicine is much cheaper in the developing part of the world. In India, a supply of 30 tablets of 50mg of oral, tablets costs USD40.

How does Mirabegron work?

Mirabegron is a selective agonist for beta-3 adrenergic receptors with high potency. Upon activation of the beta-3 receptors, the detrusor smooth muscle relaxes to allow for a larger bladder capacity. At 200 mg doses (high), there is a potential to activate beta-1 and beta-2 adrenergic receptors. Its action results in the relaxation of the muscles around the bladder. This eventually results in increased bladder capacity thus reducing the urge or need to pee as frequently or as urgently.

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