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Chemistry

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Listed Suppliers

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01

Biotechnica DWC

Algeria
BioJapan
Not Confirmed
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Biotechnica DWC

Algeria
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BioJapan
Not Confirmed

Erythropoietin EPO

About the Company : BIOTECHNICA DWC LLC has carved a niche for itself in providing value added compliance, regulatory qualification, project management and GDP guidance services to pharma companies al...

BIOTECHNICA DWC LLC has carved a niche for itself in providing value added compliance, regulatory qualification, project management and GDP guidance services to pharma companies all over the world. Biotechnica is an integrated global solution provider from design to implementation of industrial projects in the areas of Pharmaceuticals,Agri-food ,Cosmetics and Nutrition. With more than 25 years of experience in the assembly of plants, particularly in the pharmaceutical sector, we accompany our customers in the various stages of their projects – E-CTD Dossieers – Raw Materiels – Equipements – Accessories – Packaging – Distribution.
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02

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Erythropoietin EPO

About the Company : Kexing Biopharmaceuticals is a forward-thinking biopharmaceutical company primarily dedicated to research and development (R&D), manufacturing, and sales of recombinant protein the...

Kexing Biopharmaceuticals is a forward-thinking biopharmaceutical company primarily dedicated to research and development (R&D), manufacturing, and sales of recombinant protein therapeutics and microecological agents. Our focus spans various therapeutic areas including antiviral, oncology, immunology, hematology, digestion, and degenerative diseases. We have established state-of-the-art biotechnology platforms specializing in novel proteins, antibodies, and nucleic acid drugs, enabling us to stay at the forefront of pharmaceutical innovation.
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03

KinBio

Israel
BioJapan
Not Confirmed
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KinBio

Israel
arrow
BioJapan
Not Confirmed

Erythropoietin EPO

About the Company : KinBio is a rapidly growing biopharmaceutical company based in Rehovot, Israel, with its main focus on developing needed therapies as well as offering a wide range of CDMO services...

KinBio is a rapidly growing biopharmaceutical company based in Rehovot, Israel, with its main focus on developing needed therapies as well as offering a wide range of CDMO services – from concept to product. KinBio’s main focus is to pursue opportunities in the global pharmaceutical market. Augmented by a global group of affiliated companies, Kinbio specializes in research, development, manufacturing and commercialization of biopharmaceutical products. Kinbio’s commitment to top standard quality is inherent across the entire global organization, from our FDA approved cGMP sites to our state of the art R&D laboratories.
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FDF Dossiers

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01

Amgen Inc

U.S.A
BioJapan
Not Confirmed
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Amgen Inc

U.S.A
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BioJapan
Not Confirmed

EPOETIN ALFA

Brand Name : EPOGEN/PROCRIT

Dosage Form : VIAL; SINGLE-USE

Dosage Strength : 10,000U/ML

Packaging :

Approval Date :

Application Number : 103234

Regulatory Info :

Registration Country : USA

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02

Amgen Inc

U.S.A
BioJapan
Not Confirmed
arrow

Amgen Inc

U.S.A
arrow
BioJapan
Not Confirmed

EPOETIN ALFA

Brand Name : EPOGEN/PROCRIT

Dosage Form : VIAL; MULTIDOSE

Dosage Strength : 20,000U/2ML

Packaging :

Approval Date :

Application Number : 103234

Regulatory Info :

Registration Country : USA

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03

Amgen Inc

U.S.A
BioJapan
Not Confirmed
arrow

Amgen Inc

U.S.A
arrow
BioJapan
Not Confirmed

EPOETIN ALFA

Brand Name : EPOGEN/PROCRIT

Dosage Form : VIAL; MULTIDOSE

Dosage Strength : 20,000/ML

Packaging :

Approval Date :

Application Number : 103234

Regulatory Info :

Registration Country : USA

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04

Amgen Inc

U.S.A
BioJapan
Not Confirmed
arrow

Amgen Inc

U.S.A
arrow
BioJapan
Not Confirmed

EPOETIN ALFA

Brand Name : EPOGEN/PROCRIT

Dosage Form : VIAL; SINGLE-USE

Dosage Strength : 2,000U/ML

Packaging :

Approval Date :

Application Number : 103234

Regulatory Info :

Registration Country : USA

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05

Amgen Inc

U.S.A
BioJapan
Not Confirmed
arrow

Amgen Inc

U.S.A
arrow
BioJapan
Not Confirmed

EPOETIN ALFA

Brand Name : EPOGEN/PROCRIT

Dosage Form : VIAL; SINGLE-USE

Dosage Strength : 3,000U/ML

Packaging :

Approval Date :

Application Number : 103234

Regulatory Info :

Registration Country : USA

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06

Amgen Inc

U.S.A
BioJapan
Not Confirmed
arrow

Amgen Inc

U.S.A
arrow
BioJapan
Not Confirmed

EPOETIN ALFA

Brand Name : EPOGEN/PROCRIT

Dosage Form : VIAL; SINGLE-USE

Dosage Strength : 40,000U/ML

Packaging :

Approval Date :

Application Number : 103234

Regulatory Info :

Registration Country : USA

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07

Amgen Inc

U.S.A
BioJapan
Not Confirmed
arrow

Amgen Inc

U.S.A
arrow
BioJapan
Not Confirmed

EPOETIN ALFA

Brand Name : EPOGEN/PROCRIT

Dosage Form : VIAL; SINGLE-USE

Dosage Strength : 4,000U/ML

Packaging :

Approval Date :

Application Number : 103234

Regulatory Info :

Registration Country : USA

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08

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

EPOETIN ALFA-EPBX

Brand Name : RETACRIT

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 2,000UNITS/ML

Packaging :

Approval Date :

Application Number : 125545

Regulatory Info :

Registration Country : USA

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09

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

EPOETIN ALFA-EPBX

Brand Name : RETACRIT

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 3,000UNITS/ML

Packaging :

Approval Date :

Application Number : 125545

Regulatory Info :

Registration Country : USA

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10

BioJapan
Not Confirmed
arrow
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BioJapan
Not Confirmed

EPOETIN ALFA-EPBX

Brand Name : RETACRIT

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 4,000UNITS/ML

Packaging :

Approval Date :

Application Number : 125545

Regulatory Info :

Registration Country : USA

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FDA Orange Book

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01

AMGEN

U.S.A
BioJapan
Not Confirmed
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AMGEN

U.S.A
arrow
BioJapan
Not Confirmed

EPOETIN ALFA

Brand Name : EPOGEN/PROCRIT

Dosage Form : VIAL; SINGLE-USE

Dosage Strength : 10,000U/ML

Approval Date :

Application Number : 103234

RX/OTC/DISCN :

RLD :

TE Code :

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02

AMGEN

U.S.A
BioJapan
Not Confirmed
arrow

AMGEN

U.S.A
arrow
BioJapan
Not Confirmed

EPOETIN ALFA

Brand Name : EPOGEN/PROCRIT

Dosage Form : VIAL; MULTIDOSE

Dosage Strength : 20,000U/2ML

Approval Date :

Application Number : 103234

RX/OTC/DISCN :

RLD :

TE Code :

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03

AMGEN

U.S.A
BioJapan
Not Confirmed
arrow

AMGEN

U.S.A
arrow
BioJapan
Not Confirmed

EPOETIN ALFA

Brand Name : EPOGEN/PROCRIT

Dosage Form : VIAL; MULTIDOSE

Dosage Strength : 20,000/ML

Approval Date :

Application Number : 103234

RX/OTC/DISCN :

RLD :

TE Code :

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04

AMGEN

U.S.A
BioJapan
Not Confirmed
arrow

AMGEN

U.S.A
arrow
BioJapan
Not Confirmed

EPOETIN ALFA

Brand Name : EPOGEN/PROCRIT

Dosage Form : VIAL; SINGLE-USE

Dosage Strength : 2,000U/ML

Approval Date :

Application Number : 103234

RX/OTC/DISCN :

RLD :

TE Code :

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05

AMGEN

U.S.A
BioJapan
Not Confirmed
arrow

AMGEN

U.S.A
arrow
BioJapan
Not Confirmed

EPOETIN ALFA

Brand Name : EPOGEN/PROCRIT

Dosage Form : VIAL; SINGLE-USE

Dosage Strength : 3,000U/ML

Approval Date :

Application Number : 103234

RX/OTC/DISCN :

RLD :

TE Code :

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06

AMGEN

U.S.A
BioJapan
Not Confirmed
arrow

AMGEN

U.S.A
arrow
BioJapan
Not Confirmed

EPOETIN ALFA

Brand Name : EPOGEN/PROCRIT

Dosage Form : VIAL; SINGLE-USE

Dosage Strength : 40,000U/ML

Approval Date :

Application Number : 103234

RX/OTC/DISCN :

RLD :

TE Code :

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07

HOSPIRA INC

U.S.A
BioJapan
Not Confirmed
arrow

HOSPIRA INC

U.S.A
arrow
BioJapan
Not Confirmed

EPOETIN ALFA-EPBX

Brand Name : RETACRIT

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 2,000UNITS/ML

Approval Date :

Application Number : 125545

RX/OTC/DISCN :

RLD :

TE Code :

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08

HOSPIRA INC

U.S.A
BioJapan
Not Confirmed
arrow

HOSPIRA INC

U.S.A
arrow
BioJapan
Not Confirmed

EPOETIN ALFA-EPBX

Brand Name : RETACRIT

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 3,000UNITS/ML

Approval Date :

Application Number : 125545

RX/OTC/DISCN :

RLD :

TE Code :

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09

HOSPIRA INC

U.S.A
BioJapan
Not Confirmed
arrow

HOSPIRA INC

U.S.A
arrow
BioJapan
Not Confirmed

EPOETIN ALFA-EPBX

Brand Name : RETACRIT

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 4,000UNITS/ML

Approval Date :

Application Number : 125545

RX/OTC/DISCN :

RLD :

TE Code :

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10

HOSPIRA INC

U.S.A
BioJapan
Not Confirmed
arrow

HOSPIRA INC

U.S.A
arrow
BioJapan
Not Confirmed

EPOETIN ALFA-EPBX

Brand Name : RETACRIT

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10,000UNITS/ML

Approval Date :

Application Number : 125545

RX/OTC/DISCN :

RLD :

TE Code :

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Europe

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01

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Epoetin Dseta (Epoetin Zeta)

Brand Name : Retacrit

Dosage Form : Injectable Solution In Pre-Filled Syringe

Dosage Strength : 5000IU

Packaging :

Approval Date : 2008-02-27

Application Number : 07431010

Regulatory Info : Authorized

Registration Country : Spain

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02

Ratiopharm Gmbh

Germany
BioJapan
Not Confirmed
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Ratiopharm Gmbh

Germany
arrow
BioJapan
Not Confirmed

Epoetin Zeta (Epoetin Theta)

Brand Name : Eporatio

Dosage Form : Injectable Solution In Pre-Filled Syringe

Dosage Strength : 1000IU

Packaging :

Approval Date : 2009-11-25

Application Number : 09573002

Regulatory Info : Authorized

Registration Country : Spain

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03

Ratiopharm Gmbh

Germany
BioJapan
Not Confirmed
arrow

Ratiopharm Gmbh

Germany
arrow
BioJapan
Not Confirmed

Epoetin Zeta (Epoetin Theta)

Brand Name : Eporatio

Dosage Form : Injectable Solution In Pre-Filled Syringe

Dosage Strength : 20000IU

Packaging :

Approval Date : 2009-11-25

Application Number : 09573018

Regulatory Info : Authorized

Registration Country : Spain

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04

Ratiopharm Gmbh

Germany
BioJapan
Not Confirmed
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Ratiopharm Gmbh

Germany
arrow
BioJapan
Not Confirmed

Epoetin Zeta (Epoetin Theta)

Brand Name : Eporatio

Dosage Form : Injectable Solution In Pre-Filled Syringe

Dosage Strength : 30000IU

Packaging :

Approval Date : 2015-06-24

Application Number : 109573040

Regulatory Info : Authorized

Registration Country : Spain

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05

Ratiopharm Gmbh

Germany
BioJapan
Not Confirmed
arrow

Ratiopharm Gmbh

Germany
arrow
BioJapan
Not Confirmed

Epoetin Zeta (Epoetin Theta)

Brand Name : Eporatio

Dosage Form : Injectable Solution In Pre-Filled Syringe

Dosage Strength : 1000IU

Packaging :

Approval Date : 2009-11-25

Application Number : 09573001

Regulatory Info : Authorized

Registration Country : Spain

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06

Ratiopharm Gmbh

Germany
BioJapan
Not Confirmed
arrow

Ratiopharm Gmbh

Germany
arrow
BioJapan
Not Confirmed

Epoetin Zeta (Epoetin Theta)

Brand Name : Eporatio

Dosage Form : Injectable Solution In Pre-Filled Syringe

Dosage Strength : 4000IU

Packaging :

Approval Date : 2009-11-25

Application Number : 09573007

Regulatory Info : Authorized

Registration Country : Spain

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07

Ratiopharm Gmbh

Germany
BioJapan
Not Confirmed
arrow

Ratiopharm Gmbh

Germany
arrow
BioJapan
Not Confirmed

Epoetin Zeta (Epoetin Theta)

Brand Name : Eporatio

Dosage Form : Injectable Solution In Pre-Filled Syringe

Dosage Strength : 3000IU

Packaging :

Approval Date : 2009-11-25

Application Number : 09573006

Regulatory Info : Authorized

Registration Country : Spain

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08

Sandoz Gmbh

Switzerland
BioJapan
Not Confirmed
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Sandoz Gmbh

Switzerland
arrow
BioJapan
Not Confirmed

Epoetin Alpha

Brand Name : Binocrit

Dosage Form : Injectable In Pre-Filled Syringe

Dosage Strength : 30000IU

Packaging :

Approval Date : 2009-12-22

Application Number : 07410024

Regulatory Info : Authorized

Registration Country : Spain

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09

Sandoz Gmbh

Switzerland
BioJapan
Not Confirmed
arrow

Sandoz Gmbh

Switzerland
arrow
BioJapan
Not Confirmed

Epoetin Alpha

Brand Name : Binocrit,

Dosage Form : Injectable Solution In A Pre-Filled Syringe

Dosage Strength : 7000IU

Packaging :

Approval Date : 2008-10-27

Application Number : 07410018

Regulatory Info : Authorized

Registration Country : Spain

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10

Sandoz Gmbh

Switzerland
BioJapan
Not Confirmed
arrow

Sandoz Gmbh

Switzerland
arrow
BioJapan
Not Confirmed

Epoetin Alpha

Brand Name : Binocrit,

Dosage Form : Injectable Solution In A Pre-Filled Syringe

Dosage Strength : 6000IU

Packaging :

Approval Date : 2008-02-18

Application Number : 07410012

Regulatory Info : Authorized

Registration Country : Spain

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Australia

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01

Sandoz Pty Ltd

Switzerland
BioJapan
Not Confirmed
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Sandoz Pty Ltd

Switzerland
arrow
BioJapan
Not Confirmed

epoetin lambda

Brand Name : Novicrit

Dosage Form :

Dosage Strength :

Packaging : 6

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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02

Sandoz Pty Ltd

Switzerland
BioJapan
Not Confirmed
arrow

Sandoz Pty Ltd

Switzerland
arrow
BioJapan
Not Confirmed

epoetin lambda

Brand Name : Novicrit

Dosage Form :

Dosage Strength :

Packaging : 6

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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03

Sandoz Pty Ltd

Switzerland
BioJapan
Not Confirmed
arrow

Sandoz Pty Ltd

Switzerland
arrow
BioJapan
Not Confirmed

epoetin lambda

Brand Name : Novicrit

Dosage Form :

Dosage Strength :

Packaging : 6

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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04

Sandoz Pty Ltd

Switzerland
BioJapan
Not Confirmed
arrow

Sandoz Pty Ltd

Switzerland
arrow
BioJapan
Not Confirmed

epoetin lambda

Brand Name : Novicrit

Dosage Form :

Dosage Strength :

Packaging : 6

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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05

Sandoz Pty Ltd

Switzerland
BioJapan
Not Confirmed
arrow

Sandoz Pty Ltd

Switzerland
arrow
BioJapan
Not Confirmed

epoetin lambda

Brand Name : Novicrit

Dosage Form :

Dosage Strength :

Packaging : 6

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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06

Sandoz Pty Ltd

Switzerland
BioJapan
Not Confirmed
arrow

Sandoz Pty Ltd

Switzerland
arrow
BioJapan
Not Confirmed

epoetin lambda

Brand Name : Novicrit

Dosage Form :

Dosage Strength :

Packaging : 6

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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07

Sandoz Pty Ltd

Switzerland
BioJapan
Not Confirmed
arrow

Sandoz Pty Ltd

Switzerland
arrow
BioJapan
Not Confirmed

epoetin lambda

Brand Name : Novicrit

Dosage Form :

Dosage Strength :

Packaging : 6

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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08

Sandoz Pty Ltd

Switzerland
BioJapan
Not Confirmed
arrow

Sandoz Pty Ltd

Switzerland
arrow
BioJapan
Not Confirmed

epoetin lambda

Brand Name : Novicrit

Dosage Form :

Dosage Strength :

Packaging : 6

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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09

Sandoz Pty Ltd

Switzerland
BioJapan
Not Confirmed
arrow

Sandoz Pty Ltd

Switzerland
arrow
BioJapan
Not Confirmed

epoetin lambda

Brand Name : Novicrit

Dosage Form :

Dosage Strength :

Packaging : 6

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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10

Sandoz Pty Ltd

Switzerland
BioJapan
Not Confirmed
arrow

Sandoz Pty Ltd

Switzerland
arrow
BioJapan
Not Confirmed

epoetin lambda

Brand Name : Novicrit

Dosage Form :

Dosage Strength :

Packaging : 6

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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South Africa

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01

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Erythropoietin

Brand Name : Recormon 10000 Penfill

Dosage Form : INJ

Dosage Strength : 10000iu

Packaging : 84X4mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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02

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Erythropoietin

Brand Name : Recormon 20000 Penfill

Dosage Form : INJ

Dosage Strength : 20000iu

Packaging : 84X4mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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03

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Erythropoietin

Brand Name : Recormon Pre-Filled

Dosage Form : PFS

Dosage Strength : 6000iu

Packaging : 0.3X6iu

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Erythropoietin

Brand Name : Recormon Pre-Filled

Dosage Form : PFS

Dosage Strength : 4000iu

Packaging : 0.3X6iu

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

BioJapan
Not Confirmed
arrow
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BioJapan
Not Confirmed

Erythropoietin

Brand Name : Recormon Pre-Filled

Dosage Form : PFS

Dosage Strength : 2000iu

Packaging : 0.3X6iu

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

BioJapan
Not Confirmed
arrow
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BioJapan
Not Confirmed

Erythropoietin

Brand Name : Recormon Pre-Filled

Dosage Form : PFS

Dosage Strength : 10000iu

Packaging : 0.3X6iu

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

BioJapan
Not Confirmed
arrow
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BioJapan
Not Confirmed

Erythropoietin

Brand Name : Recormon 2000Iu

Dosage Form : INJ

Dosage Strength : 2000u

Packaging : 40X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

BioJapan
Not Confirmed
arrow
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BioJapan
Not Confirmed

Erythropoietin

Brand Name : Recormon Vials

Dosage Form : INJ

Dosage Strength : 1000iu

Packaging : 5X50mg/5ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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09

BioJapan
Not Confirmed
arrow
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BioJapan
Not Confirmed

Erythropoietin

Brand Name : Recormon 5000

Dosage Form : INJ

Dosage Strength : 5000u

Packaging : 5X50mg/5ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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10

BioJapan
Not Confirmed
arrow
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BioJapan
Not Confirmed

Erythropoietin

Brand Name : Eprex 6 000 I.U./0,6 ml

Dosage Form : INJ

Dosage Strength : 6000iu/0.6ml

Packaging : 0.6X6iu/0.6ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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