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01 2Alfred E Tiefenbacher GmbH

02 1ANI Pharmaceuticals Inc

03 1Accord healthcare

04 1Amicus Therapeutics

05 1Blue Fish Solvay AB

06 1Bluefish Pharmaceuticals AB

07 1Centocor

08 1Chartwell Pharmaceuticals llc

09 2Dipharma

10 1Dipharma SA

11 1Edenbridge Pharmaceuticals

12 1GEN.ORPH SAS

13 1Helsinn Advanced Synthesis

14 1Janssen-Cilag

15 5Johnson & Johnson Innovative Medicine

16 1Navinta

17 1Piramal Critical Care

18 1Sandoz B2B

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : Registered in EU

Registration Country : Germany

Miglustat

Brand Name :

Dosage Form : Hard Capsule

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Tiefenbacher Compnay Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : Registered in EU

Registration Country : Germany

Miglustat

Brand Name :

Dosage Form : Hard Capsule

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Tiefenbacher Compnay Banner

03

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

Miglustat

Brand Name : MIGLUSTAT ACCORD

Dosage Form : Hard Capsules

Dosage Strength : 100 mg

Packaging : 84 UNITS 100 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

MIGLUSTAT

Brand Name : OPFOLDA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 65MG

Packaging :

Approval Date : 2023-09-28

Application Number : 215211

Regulatory Info : RX

Registration Country : USA

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05

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

MIGLUSTAT

Brand Name : MIGLUSTAT

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date : 2018-04-17

Application Number : 208342

Regulatory Info : RX

Registration Country : USA

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06

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

miglustat

Brand Name : Miglustat Bluefish

Dosage Form : KAPSEL, HÅRD

Dosage Strength : 100 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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07

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

MIGLUSTAT

Brand Name : ZAVESCA

Dosage Form : CAPSULE

Dosage Strength : 100MG

Packaging : 90(6X15)

Approval Date :

Application Number : 2250519

Regulatory Info : Prescription

Registration Country : Canada

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08

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

MIGLUSTAT

Brand Name : MIGLUSTAT

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date : 2022-02-03

Application Number : 209325

Regulatory Info : DISCN

Registration Country : USA

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09

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

Miglustat

Brand Name : Dilusta

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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10

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

Miglustat

Brand Name : MIGLUSTAT DIPHARMA

Dosage Form : Hard Capsule

Dosage Strength : 100 mg

Packaging : 84 UNITS 100 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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11

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

Miglustatum

Brand Name : Miglustat Dipharma

Dosage Form : Kaps

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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12

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

MIGLUSTAT

Brand Name : YARGESA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date : 2020-08-06

Application Number : 209821

Regulatory Info : RX

Registration Country : USA

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13

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

Miglustat

Brand Name : ZAVESCA

Dosage Form : Hard Capsules

Dosage Strength : 100 mg

Packaging : 84 UNITS 100 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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14

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

Miglustatum

Brand Name : Zavesca

Dosage Form : Caps

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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15

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

MIGLUSTAT

Brand Name : ZAVESCA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date : 2003-07-31

Application Number : 21348

Regulatory Info : RX

Registration Country : USA

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16

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

miglustat

Brand Name : Zavesca

Dosage Form : HARD CAPSULES

Dosage Strength : 100 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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17

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

Miglustat

Brand Name : Zavea

Dosage Form : Miglustat 100Mg 84 Combined Oral Use

Dosage Strength : 84 cps 100 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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18

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

Miglustat

Brand Name : Zavesca

Dosage Form : Capsule, hard

Dosage Strength : 100 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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19

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

MIGLUSTAT

Brand Name : ZAVESCA®

Dosage Form : CAP

Dosage Strength : 100mg

Packaging : 84X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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20

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

MIGLUSTAT

Brand Name : MIGLUSTAT

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date : 2025-03-14

Application Number : 219111

Regulatory Info : RX

Registration Country : USA

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21

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

Miglustat

Brand Name : YARGESA

Dosage Form : Hard Capsule Oral Use Blister

Dosage Strength : 100 mg

Packaging : 84 UNITS 100 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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22

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

MIGLUSTAT

Brand Name : SANDOZ MIGLUSTAT

Dosage Form : CAPSULE

Dosage Strength : 100MG

Packaging : 90

Approval Date :

Application Number : 2456257

Regulatory Info : Prescription

Registration Country : Canada

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23

Blue Fish Solvay AB

Country
AACR Annual meeting
Not Confirmed
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Blue Fish Solvay AB

Country
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AACR Annual meeting
Not Confirmed

Miglustat

Brand Name : Miglustat Blue Fish

Dosage Form : Capsule, hard

Dosage Strength : 100 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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24

GEN.ORPH SAS

Country
AACR Annual meeting
Not Confirmed
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GEN.ORPH SAS

Country
arrow
AACR Annual meeting
Not Confirmed

Miglustat

Brand Name : MIGLUSTAT GEN ORPH

Dosage Form : Hard Capsule

Dosage Strength : 100 mg

Packaging : 84 UNITS 100 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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