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01 2Alfred E Tiefenbacher GmbH

02 1ANI Pharmaceuticals Inc

03 2Accord healthcare

04 7Amicus Therapeutics

05 3Bluefish Pharmaceuticals AB

06 1Centocor

07 1Chartwell Pharmaceuticals llc

08 6Dipharma

09 1Dipharma SA

10 1Edenbridge Pharmaceuticals

11 1GEN.ORPH SAS

12 2Gen.Orph

13 1Gen.Orph (1)

14 2Gen.Orph Sas

15 1Glenmark Pharmaceuticals

16 1Helsinn Advanced Synthesis

17 6Janssen-Cilag

18 3Johnson & Johnson Innovative Medicine

19 1Navinta

20 5Piramal Critical Care

21 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

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
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

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
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

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Miglustatum

Brand Name : Opfolda

Dosage Form : Hard Capsule

Dosage Strength : 65mg

Packaging :

Approval Date : 04/07/2024

Application Number : 67806

Regulatory Info : Allowed

Registration Country : Switzerland

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06

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
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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07

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Miglustat

Brand Name : Miglustat Bluefish

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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08

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
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

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
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

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
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

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Miglustatum

Brand Name : Miglustat Dipharma

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date : 03/04/2020

Application Number : 67633

Regulatory Info : Allowed

Registration Country : Switzerland

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12

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
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

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
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

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Miglustatum

Brand Name : Zavesca

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date : 22/10/2004

Application Number : 56898

Regulatory Info : Allowed

Registration Country : Switzerland

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15

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
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

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
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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17

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
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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18

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
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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19

GEN.ORPH SAS

Country
International Sweetener Colloquium
Not Confirmed
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GEN.ORPH SAS

Country
arrow
International Sweetener Colloquium
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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20

Gen.Orph (1)

Country
International Sweetener Colloquium
Not Confirmed
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Gen.Orph (1)

Country
arrow
International Sweetener Colloquium
Not Confirmed

Miglustat

Brand Name : Miglustat GenOrph

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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