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01 2Pharmathen SA

02 3APGDI

03 2Alkem Laboratories

04 2Apotex Inc

05 19Astellas Pharma

06 1Aurobindo Pharma Limited

07 2Cipla Medpro South Africa

08 2KMS Health Center

09 2Lupin Ltd

10 2Qilu Pharmaceutical

11 2Sawai Pharmaceutical Co

12 2Tecnimede

13 2Unichem Laboratories Limited

14 1Whanin Pharmaceutical

15 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

IMCAS Asia
Not Confirmed
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IMCAS Asia
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

IMCAS Asia
Not Confirmed
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IMCAS Asia
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
IMCAS Asia
Not Confirmed
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APGDI

U.S.A
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IMCAS Asia
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
IMCAS Asia
Not Confirmed
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APGDI

U.S.A
arrow
IMCAS Asia
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
IMCAS Asia
Not Confirmed
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APGDI

U.S.A
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IMCAS Asia
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

IMCAS Asia
Not Confirmed
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IMCAS Asia
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 : RX

Registration Country : USA

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09

IMCAS Asia
Not Confirmed
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IMCAS Asia
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 : RX

Registration Country : USA

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10

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

Mirabegron

Brand Name : Betmiga

Dosage Form : PROLONGED-RELEASE TABLET

Dosage Strength : 50 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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11

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

Mirabegron

Brand Name : Betmiga

Dosage Form : PROLONGED-RELEASE TABLET

Dosage Strength : 25 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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12

IMCAS Asia
Not Confirmed
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IMCAS Asia
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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13

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

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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14

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

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

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15

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

MIRABEGRON

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number : 217989

Regulatory Info :

Registration Country : USA

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16

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

MIRABEGRON

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number : 217989

Regulatory Info :

Registration Country : USA

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17

IMCAS Asia
Not Confirmed
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IMCAS Asia
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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18

IMCAS Asia
Not Confirmed
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IMCAS Asia
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 : RX

Registration Country : USA

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19

IMCAS Asia
Not Confirmed
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IMCAS Asia
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

IMCAS Asia
Not Confirmed
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IMCAS Asia
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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