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01 2Pharmathen SA

02 3APGDI

03 1Adalvo

04 3Alkem Laboratories

05 2Alter Laboratories Sa

06 2Apotex Inc

07 20Astellas Pharma

08 1Aurobindo Pharma Limited

09 1Avansor Pharma Oy

10 1CLONMEL HLTHCARE

11 1Cinfa

12 2Cipla Medpro South Africa

13 1GSK

14 1Glenmark Pharmaceuticals

15 2KMS Health Center

16 1LABORATORIOS NORMON SA

17 2Lupin Ltd

18 2MSN Laboratories

19 1Q Pharma Laboratories Sl

20 2Qilu Pharmaceutical

21 3STADA Arzneimittel

22 2Sawai Pharmaceutical Co

23 1Sunshine Lake Pharma

24 2Tecnimede

25 3Teva Pharmaceutical Industries

26 2Unichem Laboratories Limited

27 1Whanin Pharmaceutical

28 4Zentiva

29 2Zydus Pharmaceuticals

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Regulatory Info :

Registration Country : Greece

Mirabegron

Brand Name :

Dosage Form : Prolonged Release Tablet

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Greece

Pharmathen

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Regulatory Info :

Registration Country : Greece

Mirabegron

Brand Name :

Dosage Form : Prolonged Release Tablet

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Greece

Pharmathen

03

Alkem Laboratories

BPI Europe
Not Confirmed
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Alkem Laboratories

arrow
BPI Europe
Not Confirmed

MIRABEGRON

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 2024-02-12

Application Number : 215948

Regulatory Info : RX

Registration Country : USA

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04

Alkem Laboratories

BPI Europe
Not Confirmed
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Alkem Laboratories

arrow
BPI Europe
Not Confirmed

MIRABEGRON

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date : 2024-02-12

Application Number : 215948

Regulatory Info : RX

Registration Country : USA

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05

APGDI

U.S.A
BPI Europe
Not Confirmed
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APGDI

U.S.A
arrow
BPI Europe
Not Confirmed

MIRABEGRON

Brand Name : MYRBETRIQ

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 2012-06-28

Application Number : 202611

Regulatory Info : RX

Registration Country : USA

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06

APGDI

U.S.A
BPI Europe
Not Confirmed
arrow

APGDI

U.S.A
arrow
BPI Europe
Not Confirmed

MIRABEGRON

Brand Name : MYRBETRIQ

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date : 2012-06-28

Application Number : 202611

Regulatory Info : RX

Registration Country : USA

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07

APGDI

U.S.A
BPI Europe
Not Confirmed
arrow

APGDI

U.S.A
arrow
BPI Europe
Not Confirmed

MIRABEGRON

Brand Name : MYRBETRIQ GRANULES

Dosage Form : FOR SUSPENSION, EXTENDED RELEASE;ORAL

Dosage Strength : 8MG/ML

Packaging :

Approval Date : 2021-03-25

Application Number : 213801

Regulatory Info : RX

Registration Country : USA

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08

BPI Europe
Not Confirmed
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arrow
BPI Europe
Not Confirmed

MIRABEGRON

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 2025-01-02

Application Number : 209434

Regulatory Info : DISCN

Registration Country : USA

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09

BPI Europe
Not Confirmed
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arrow
BPI Europe
Not Confirmed

MIRABEGRON

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date : 2025-01-02

Application Number : 209434

Regulatory Info : DISCN

Registration Country : USA

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10

BPI Europe
Not Confirmed
arrow
arrow
BPI Europe
Not Confirmed

MIRABEGRON

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number : 209413

Regulatory Info :

Registration Country : USA

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11

MIRABEGRON

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 2022-09-28

Application Number : 209485

Regulatory Info : RX

Registration Country : USA

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12

MIRABEGRON

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date : 2022-09-28

Application Number : 209485

Regulatory Info : RX

Registration Country : USA

blank

13

BPI Europe
Not Confirmed
arrow
arrow
BPI Europe
Not Confirmed

MIRABEGRON

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 2025-11-04

Application Number : 218543

Regulatory Info : RX

Registration Country : USA

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14

BPI Europe
Not Confirmed
arrow
arrow
BPI Europe
Not Confirmed

MIRABEGRON

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 2025-06-30

Application Number : 217989

Regulatory Info : RX

Registration Country : USA

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15

BPI Europe
Not Confirmed
arrow
arrow
BPI Europe
Not Confirmed

MIRABEGRON

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date : 2025-06-30

Application Number : 217989

Regulatory Info : RX

Registration Country : USA

blank

16

BPI Europe
Not Confirmed
arrow
arrow
BPI Europe
Not Confirmed

MIRABEGRON

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 2019-12-27

Application Number : 209446

Regulatory Info : DISCN

Registration Country : USA

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17

BPI Europe
Not Confirmed
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arrow
BPI Europe
Not Confirmed

MIRABEGRON

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date : 2025-05-06

Application Number : 217061

Regulatory Info : DISCN

Registration Country : USA

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18

BPI Europe
Not Confirmed
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arrow
BPI Europe
Not Confirmed

MIRABEGRON

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number : 216757

Regulatory Info :

Registration Country : USA

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19

BPI Europe
Not Confirmed
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arrow
BPI Europe
Not Confirmed

MIRABEGRON

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 2022-09-29

Application Number : 209488

Regulatory Info : RX

Registration Country : USA

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20

BPI Europe
Not Confirmed
arrow
arrow
BPI Europe
Not Confirmed

MIRABEGRON

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date : 2022-09-29

Application Number : 209488

Regulatory Info : RX

Registration Country : USA

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