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01 6Horizon Therapeutics

02 6ORPHAN EUROPE SARL

03 2Raptor Pharmaceuticals Europe BV

04 2Raptor Solvay *Europe B.V.

05 2Viatris

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PharmaCompass

01

Antibody Engineering
Not Confirmed
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Antibody Engineering
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CYSTEAMINE BITARTRATE

Brand Name : PROCYSBI

Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

Dosage Strength : EQ 25MG BASE

Packaging :

Approval Date : 2013-04-30

Application Number : 203389

Regulatory Info : RX

Registration Country : USA

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02

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

CYSTEAMINE BITARTRATE

Brand Name : PROCYSBI

Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

Dosage Strength : EQ 75MG BASE

Packaging :

Approval Date : 2013-04-30

Application Number : 203389

Regulatory Info : RX

Registration Country : USA

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03

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

CYSTEAMINE BITARTRATE

Brand Name : PROCYSBI

Dosage Form : GRANULE, DELAYED RELEASE;ORAL

Dosage Strength : EQ 75MG BASE/PACKET

Packaging :

Approval Date : 2020-02-14

Application Number : 213491

Regulatory Info : RX

Registration Country : USA

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04

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

CYSTEAMINE BITARTRATE

Brand Name : PROCYSBI

Dosage Form : GRANULE, DELAYED RELEASE;ORAL

Dosage Strength : EQ 300MG BASE/PACKET

Packaging :

Approval Date : 2020-02-14

Application Number : 213491

Regulatory Info : RX

Registration Country : USA

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05

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

CYSTEAMINE (CYSTEAMINE BITARTRATE)

Brand Name : PROCYSBI

Dosage Form : CAPSULE (DELAYED RELEASE)

Dosage Strength : 75MG

Packaging :

Approval Date :

Application Number : 2464713

Regulatory Info : Prescription

Registration Country : Canada

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06

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

CYSTEAMINE (CYSTEAMINE BITARTRATE)

Brand Name : PROCYSBI

Dosage Form : CAPSULE (DELAYED RELEASE)

Dosage Strength : 25MG

Packaging : 50

Approval Date :

Application Number : 2464705

Regulatory Info : Prescription

Registration Country : Canada

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07

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

merkaptaminbitartrat

Brand Name : CYSTAGON

Dosage Form : HARD CAPSULES

Dosage Strength : 50 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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08

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

merkaptaminbitartrat

Brand Name : CYSTAGON

Dosage Form : HARD CAPSULES

Dosage Strength : 150 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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09

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Cysteamine Bitartrate

Brand Name : Cystagon

Dosage Form : Mercaptamine 50Mg 100 Unita' Oral Use

Dosage Strength : 100 cps 50 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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10

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Cysteamine Bitartrate

Brand Name : Cystagon

Dosage Form : Mercaptamine 150Mg 100 Unita' Oral Use

Dosage Strength : 100 cps 150 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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11

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Cysteamine Bitartrate

Brand Name : Cystagon

Dosage Form : Capsule, hard

Dosage Strength : 150 mg

Packaging : Box of plastic

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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12

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Cysteamine Bitartrate

Brand Name : Cystagon

Dosage Form : Capsule, hard

Dosage Strength : 50 mg

Packaging : Box of plastic

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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13

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

CYSTEAMINE BITARTRATE

Brand Name : CYSTAGON

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 50MG BASE

Packaging :

Approval Date : 1994-08-15

Application Number : 20392

Regulatory Info : RX

Registration Country : USA

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14

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

CYSTEAMINE BITARTRATE

Brand Name : CYSTAGON

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 150MG BASE

Packaging :

Approval Date : 1994-08-15

Application Number : 20392

Regulatory Info : RX

Registration Country : USA

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15

Raptor Pharmaceuticals Europe BV

Country
Antibody Engineering
Not Confirmed
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Raptor Pharmaceuticals Europe BV

Country
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Antibody Engineering
Not Confirmed

merkaptaminbitartrat

Brand Name : Procysbi

Dosage Form : GASTRO-RESISTANT CAPSULE, HARD

Dosage Strength : 75 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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16

Raptor Pharmaceuticals Europe BV

Country
Antibody Engineering
Not Confirmed
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Raptor Pharmaceuticals Europe BV

Country
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Antibody Engineering
Not Confirmed

merkaptaminbitartrat

Brand Name : Procysbi

Dosage Form : GASTRO-RESISTANT CAPSULE, HARD

Dosage Strength : 25 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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17

Raptor Solvay *Europe B.V.

Country
Antibody Engineering
Not Confirmed
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Raptor Solvay *Europe B.V.

Country
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Antibody Engineering
Not Confirmed

Cysteamine Bitartrate

Brand Name : Procysbi

Dosage Form : Enteric Capsule

Dosage Strength : 25 mg

Packaging : Box

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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18

Raptor Solvay *Europe B.V.

Country
Antibody Engineering
Not Confirmed
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Raptor Solvay *Europe B.V.

Country
arrow
Antibody Engineering
Not Confirmed

Cysteamine Bitartrate

Brand Name : Procysbi

Dosage Form : Enteric Capsule

Dosage Strength : 75 mg

Packaging : Box

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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