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01 5Baxter Healthcare Corporation

02 10Bayer AG

03 1Cherubino Limited

04 1EJ Busuttil Ltd

05 2Health Biotech

06 1Hekim Pharmaceuticals

07 1Miller and Miller Chemicals

08 1Mirpharm

09 2Nordic Pharma

10 1Zlb Behring Gmbh

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PharmaCompass

01

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

APROTININ (SYNTHETIC)

Brand Name : TISSEEL

Dosage Form : KIT

Dosage Strength : 3000KIU/ML

Packaging : 2ML/4ML/10ML

Approval Date :

Application Number : 2326132

Regulatory Info : Schedule D

Registration Country : Canada

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02

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

APROTININ (SYNTHETIC)

Brand Name : ARTISS

Dosage Form : SOLUTION

Dosage Strength : 3000KIU/ML

Packaging : 2ML/4ML/10ML (TOTAL VOLUME)

Approval Date :

Application Number : 2326167

Regulatory Info : Prescription

Registration Country : Canada

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03

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

APROTININ (SYNTHETIC)

Brand Name : TISSEEL

Dosage Form : SOLUTION

Dosage Strength : 3000KIU/ML

Packaging : 2ML/4ML/10ML (TOTAL VOLUME)

Approval Date :

Application Number : 2326175

Regulatory Info : Schedule D

Registration Country : Canada

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04

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Aprotinin

Brand Name : Tisseel

Dosage Form : POW

Dosage Strength : 3000KIU/ml

Packaging : 2X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Aprotinin

Brand Name : Tisseel

Dosage Form : POW

Dosage Strength : 3000KIU/ml

Packaging : 4X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

APROTININ

Brand Name : TRASYLOL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10,000KIU/ML

Packaging :

Approval Date :

Application Number : 20304

Regulatory Info :

Registration Country : USA

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07

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Aprotinin Bovine; Human Fibrinogen; Calcium Chloride Dihydrate; Human Coagulation Factor XIII; Human Thrombin

Brand Name : Tisseel

Dosage Form : Solution

Dosage Strength :

Packaging :

Approval Date : 26/02/2010

Application Number : 20070210000026

Regulatory Info : Deregistered

Registration Country : Sweden

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08

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Aprotinin Bovine; Human Fibrinogen; Human Fibronectin; Calcium Chloride Dihydrate; Human Coagulation Factor XIII; Human Plasminogen; Human Thrombin

Brand Name : Tisseel Kit

Dosage Form : Solution

Dosage Strength :

Packaging :

Approval Date : 19/01/1995

Application Number : 19950119000027

Regulatory Info : Deregistered

Registration Country : Sweden

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09

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Aprotinin Bovine; Human Fibrinogen; Human Fibronectin; Calcium Chloride Dihydrate; Human Coagulation Factor XIII; Human Plasminogen; Human Thrombin

Brand Name : Tisseel Duo Quick

Dosage Form : Solution

Dosage Strength :

Packaging :

Approval Date : 19/01/1995

Application Number : 19950119000010

Regulatory Info : Deregistered

Registration Country : Sweden

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10

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Aprotinin

Brand Name : Trasylol Inj 100Ml

Dosage Form : INJ

Dosage Strength : 140mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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11

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Human Fibrinogen; Aprotinin; Human Thrombin; Calcium Chloride Dihydrate

Brand Name : Tisseel –

Dosage Form : SOLUTION FOR SEALANT

Dosage Strength : 182MG; 6000KALLIKREININACTIVATORUNIT/ML; 1000IU; 80MMOL

Packaging :

Approval Date : 2014-07-29

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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12

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Aprotinin

Brand Name :

Dosage Form : Vial

Dosage Strength : 50000IU

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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13

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Aprotinin

Brand Name :

Dosage Form : Vial

Dosage Strength : 100000IU

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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14

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Aprotinin

Brand Name :

Dosage Form : Solution for Intravenous

Dosage Strength : 10000KIE/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Russia

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15

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Apricot

Brand Name : Trasylol

Dosage Form : Solution For Injection/Infusion

Dosage Strength :

Packaging :

Approval Date : 16/03/1977

Application Number : 38837

Regulatory Info : Allowed

Registration Country : Switzerland

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16

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Aprotinin, Bovint

Brand Name : Trasylol

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 10000KIE/ml

Packaging :

Approval Date : 13/12/1967

Application Number : 19671213000033

Regulatory Info : Approved

Registration Country : Sweden

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17

Zlb Behring Gmbh

Country
CPhI India
Not Confirmed
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Zlb Behring Gmbh

Country
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CPhI India
Not Confirmed

Aprotinin Bovine; Human Fibrinogen; Calcium Chloride Dihydrate; Human Coagulation Factor XIII; Human Thrombin

Brand Name : Beriplast P Combi-Set

Dosage Form : Solution

Dosage Strength :

Packaging :

Approval Date : 10/08/2001

Application Number : 20010810000125

Regulatory Info : Deregistered

Registration Country : Sweden

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18

Miller and Miller Chemicals

Country
CPhI India
Not Confirmed
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Miller and Miller Chemicals

Country
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CPhI India
Not Confirmed

Aprotinin

Brand Name : Aprotinin

Dosage Form : Solution For Injection

Dosage Strength : 10000KALLIKREININACTIVATORUNIT/ML

Packaging :

Approval Date : 2019-06-13

Application Number :

Regulatory Info : Invalid

Registration Country : Malta

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19

Cherubino Limited

Country
CPhI India
Not Confirmed
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Cherubino Limited

Country
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CPhI India
Not Confirmed

Aprotinin

Brand Name : Aprotinin

Dosage Form : Solution For Injection

Dosage Strength : 100000KALLIKREININACTIVATORUNIT/ML

Packaging :

Approval Date : 2020-10-14

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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20

EJ Busuttil Ltd

Country
CPhI India
Not Confirmed
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EJ Busuttil Ltd

Country
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CPhI India
Not Confirmed

Aprotinin

Brand Name : Trasylol

Dosage Form : Solution For Infusion

Dosage Strength : 1.4MG/ML

Packaging :

Approval Date : 2025-05-28

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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