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01 25Kyowa Kirin

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PharmaCompass

01

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

BUROSUMAB-TWZA

Brand Name : CRYSVITA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10MG/ML

Packaging :

Approval Date :

Application Number : 761068

Regulatory Info :

Registration Country : USA

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02

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Burosumab

Brand Name : Crysvita

Dosage Form : Injectable Solution

Dosage Strength : 10mg

Packaging :

Approval Date : 19/02/2018

Application Number : 20161206000011

Regulatory Info : Approved

Registration Country : Sweden

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03

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Burosumab

Brand Name : Crysvita

Dosage Form : Solution For Injection

Dosage Strength : 10mg

Packaging :

Approval Date : 30/11/2023

Application Number : 20230530000063

Regulatory Info : Approved

Registration Country : Sweden

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04

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Burosumab

Brand Name : Crysvita

Dosage Form : Injectable Solution

Dosage Strength : 20mg

Packaging :

Approval Date : 19/02/2018

Application Number : 20161206000028

Regulatory Info : Approved

Registration Country : Sweden

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05

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Burosumab

Brand Name : Crysvita

Dosage Form : Solution For Injection

Dosage Strength : 20mg

Packaging :

Approval Date : 30/11/2023

Application Number : 20230530000070

Regulatory Info : Approved

Registration Country : Sweden

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06

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Burosumab

Brand Name : Crysvita

Dosage Form : Injectable Solution

Dosage Strength : 30mg

Packaging :

Approval Date : 19/02/2018

Application Number : 20161206000035

Regulatory Info : Approved

Registration Country : Sweden

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07

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Burosumab

Brand Name : Crysvita

Dosage Form : Solution For Injection

Dosage Strength : 30mg

Packaging :

Approval Date : 30/11/2023

Application Number : 20230530000087

Regulatory Info : Approved

Registration Country : Sweden

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08

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Burosumab

Brand Name : Crysvita

Dosage Form : Solution For Injection

Dosage Strength : 10mg/ml

Packaging :

Approval Date : 20/01/2020

Application Number : 66801

Regulatory Info : Allowed

Registration Country : Switzerland

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09

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Burosumab

Brand Name : Crysvita

Dosage Form : Solution For Injection

Dosage Strength : 20mg/ml

Packaging :

Approval Date : 20/01/2020

Application Number : 66801

Regulatory Info : Allowed

Registration Country : Switzerland

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10

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Burosumab

Brand Name : Crysvita

Dosage Form : Solution For Injection

Dosage Strength : 30mg/ml

Packaging :

Approval Date : 20/01/2020

Application Number : 66801

Regulatory Info : Allowed

Registration Country : Switzerland

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11

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Burosumab

Brand Name : Crysvita

Dosage Form : Injectable Solution In Pre-Filled Syringe

Dosage Strength : 10MG

Packaging :

Approval Date : 2024-08-13

Application Number : 1171262004

Regulatory Info : Authorized

Registration Country : Spain

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12

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Burosumab

Brand Name : Crysvita

Dosage Form : Injectable Solution

Dosage Strength : 30MG

Packaging :

Approval Date : 2018-05-11

Application Number : 1171262003

Regulatory Info : Authorized

Registration Country : Spain

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13

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Burosumab

Brand Name : Crysvita

Dosage Form : Injectable Solution In Pre-Filled Syringe

Dosage Strength : 20MG

Packaging :

Approval Date : 2024-08-13

Application Number : 1171262005

Regulatory Info : Authorized

Registration Country : Spain

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14

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Burosumab

Brand Name : Crysvita

Dosage Form : Injectable Solution

Dosage Strength : 20MG

Packaging :

Approval Date : 2018-05-11

Application Number : 1171262002

Regulatory Info : Authorized

Registration Country : Spain

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15

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Burosumab

Brand Name : Crysvita

Dosage Form : Injectable Solution

Dosage Strength : 10MG

Packaging :

Approval Date : 2018-05-11

Application Number : 1171262001

Regulatory Info : Authorized

Registration Country : Spain

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16

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Burosumab

Brand Name : Crysvita

Dosage Form : Injectable Solution In Pre-Filled Syringe

Dosage Strength : 30MG

Packaging :

Approval Date : 2024-08-13

Application Number : 1171262006

Regulatory Info : Authorized

Registration Country : Spain

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17

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

BUROSUMAB

Brand Name : CRYSVITA

Dosage Form : SOLUTION

Dosage Strength : 10MG/ML

Packaging :

Approval Date :

Application Number : 2483629

Regulatory Info : Prescription

Registration Country : Canada

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18

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

BUROSUMAB

Brand Name : CRYSVITA

Dosage Form : SOLUTION

Dosage Strength : 20MG/ML

Packaging :

Approval Date :

Application Number : 2483637

Regulatory Info : Schedule D

Registration Country : Canada

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19

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

BUROSUMAB

Brand Name : CRYSVITA

Dosage Form : SOLUTION

Dosage Strength : 30MG/ML

Packaging :

Approval Date :

Application Number : 2483645

Regulatory Info : Prescription

Registration Country : Canada

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20

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Burosumab

Brand Name : Crysvita

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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