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Mirabegron manufacturers

24 products found

Filters

24 products found

mirabegron

Tablets, prolonged release (PR) 25 mg, 50 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Available for
Licensing with supply
Comments
Reference product: Betmiga
Manufacturer #19112
A pharmaceutical manufacturer based in the EU that develops and produces generic medicines and sells its products in the EU, North America, LATAM, and Africa. Main therapeutic areas include diabetes, urology, and antidepressant. The company possesses its own R&D and regulatory department.

Manufacturer usually replies in 6 days

mirabegron

Oral suspension 10 mg/ml

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Modified release oral suspension.Early stage
Manufacturer #8593
It is a private R&D and business development organization established in the 2000s, specializing in the design and development of new pharmaceutical products worldwide. They have an average of 5-6 new developments per year, an average of 8-10 DCPs per year, more than 60 dossier updates in the last 10 years, they have more than 3 valid and approved patent applications, and approximately 140 MAs worldwide.

Manufacturer usually replies in 2 days

mirabegron

Tablets 25 mg, 50 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Comments
Ref: Betmiga (Astellas Pharma Europe)
Manufacturer #263
A pharmaceutical manufacturer based in the EU that has been active in 70+ countries selling its products all over the world for 40+ years. Key production lines are Rx, nutraceuticals, and medical devices. The company's production lines are GMP-compliant. The main dosage form is a solid oral dosage form.

Manufacturer usually replies in 9 days

mirabegron + solifenacin

Tablets 25 mg + 5 mg, 50 mg + 5 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #21467

Manufacturer usually replies in 9 days

mirabegron

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

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Comments
EU MA's Running
Manufacturer #21467

Manufacturer usually replies in 9 days

mirabegron

Tablets, extended release (ER) 50 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Dossier availability date: Q3 2024This product is under registration in European Union
Manufacturer #17047
A pharmaceutical manufacturer based in the EU that sells its products in Europe, the Middle East, CIS, LATAM, and Asia. Key production lines are pharmaceuticals, bio and nanopharmaceuticals, medical devices, and nutraceuticals. The main therapeutic area is oncology.

Manufacturer usually replies in 10 days

mirabegron + solifenacin

Tablets, film coated 25 mg + 5 mg, 50 mg + 5 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Reference product: Betmiga + Vesicare
Manufacturer #19112
A pharmaceutical manufacturer based in the EU that develops and produces generic medicines and sells its products in the EU, North America, LATAM, and Africa. Main therapeutic areas include diabetes, urology, and antidepressant. The company possesses its own R&D and regulatory department.

Manufacturer usually replies in 6 days

mirabegron

Tablets, prolonged release (PR) 25 mg, 50 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Unavailable markets
Portugal , Vietnam
Comments
Dossier availability date: Q2 2024
Manufacturer #437
A pharmaceutical manufacturer based in the EU that is active in 40+ countries selling its products in Europe, North America, LATAM, Africa, Middle East, and Asia for 40+ years. Main therapeutics areas include the nervous system, cardiometabolic, and women’s health. The company's production lines are GMP-compliant. The main dosage forms are solid, semi-solid, liquid, and suspension. The company owns branches in the EU, Africa, and LATAM.

Manufacturer usually replies in 11 days

mirabegron

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

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP, Japan
Manufacturer #31058

Manufacturer usually replies in nan days

mirabegron

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

Dossier type
EU CTD
Dossier status
Under development
Country of origin
Turkey
GMP approvals
EU GMP
Manufacturer #13095

Manufacturer usually replies in 5 days

mirabegron

Tablets, prolonged release (PR) 25 mg , 50 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP
Unavailable markets
Chile , Panama
Available for
Licensing with supply
Manufacturer #261
A pharmaceutical manufacturer based in the EU that has been selling its products in Europe for 20+ years. Main therapeutic areas include diabetes, CNL, dermatology, and oncology. Main dosage forms include solid and liquid oral, sterile dosage forms, and ointments. The company possesses 10+ manufacturing facilities that are cGMP-compliant.

Manufacturer usually replies in 6 days

mirabegron

Tablets, prolonged release (PR) 25 mg, 50 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP
Manufacturer #21496

It's a fully integrated pharmaceutical corporation with a global reach. The company specializes in CMO and CDMO pharmaceutical preparations in a variety of dosage forms for a variety of therapeutic categories. GSK, Pfizer, Sanofi, Novartis, Mylan, Apotex, Adcock Ingram, and other MNCs manufacture formulations in various dosage forms for customers in 55 countries in important markets such as Europe, Australia & New Zealand, Canada, Japan, Far East Asia, GCC, Africa, LATAM, and CIS.

Manufacturer usually replies in 9 days

mirabegron

Tablets 25 mg, 50 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP
Comments
Dossier availability date: Q3 2024
Manufacturer #18975

Manufacturer usually replies in 6 days

mirabegron

Tablets, prolonged release (PR) 25 mg, 50 mg

Dossier type
CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP
Manufacturer #15176

Manufacturer usually replies in 5 days

mirabegron

Tablets, film coated 25 mg, 50 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Bangladesh
GMP approvals
WHO
Manufacturer #21084

Manufacturer usually replies in 5 days

mirabegron

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

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Bangladesh
GMP approvals
WHO
Manufacturer #21340

Manufacturer usually replies in 8 days

mirabegron

Tablets, prolonged release (PR) 25mg, 50mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Argentina
GMP approvals
Argentina
Available for
Distribution only
Manufacturer #16240
It is a laboratory that produces several product lines, such as allergy, cardiology, clinic, dermatology, gastroenterology, geriatrics, neurology, pediatrics, psychiatry, and urology, among others.

Manufacturer usually replies in 6 days

mirabegron

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

Dossier type
EU CTD
Dossier status
Under development
Country of origin
India
GMP approvals
FDA, EU GMP, WHO, MHRA
Manufacturer #16394

Manufacturer usually replies in 12 days

mirabegron

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

Dossier type
US CTD
Dossier status
Under development
Country of origin
India
GMP approvals
FDA, Canada
Manufacturer #16394

Manufacturer usually replies in 12 days

mirabegron

Vaginal gel 25 mg, 50 mg

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
FDA
Unavailable markets
South Africa
Registered in
United States
Available for
Licensing with supply, Technology transfer
Manufacturer #21501

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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.

Finding Mirabegron Manufacturers and Suppliers

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