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6 RELATED EXCIPIENT COMPANIES

14EXCIPIENTS BY APPLICATIONS

Chemistry

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[{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725042600,"product":"TRASTUZUMAB DRUG SUBSTANCE(36.4MG\/ML X 50ML)(1.820 GMS)","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"DR. REDDY\\'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"VNUKOVO","customer":"R-PHARM","customerCountry":"RUSSIA","quantity":"0.00","actualQuantity":"1.82","unit":"GMS","unitRateFc":"1205","totalValueFC":"1892.1","currency":"USD","unitRateINR":87200.88461538461,"date":"31-Aug-2024","totalValueINR":"158705.61","totalValueInUsd":"1892.1","indian_port":"Hyderabad Air","hs_no":"29379020","bill_no":"3660208","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE, HYDERABAD ANDHRA PRADESH","customerAddress":""}]
31-Aug-2024
31-Aug-2024
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
(KGS)
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(USD/KGS)
Number of Transactions

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Drugs in Development

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Details:

BBO-10203 is a first-in-class orally bioavailable RAS:PI3Ka breaker that blocks the interaction between RAS and PI3Kα to inhibit PI3Kα-AKT signaling in tumors.


Lead Product(s): BBO-10203,Trastuzumab

Therapeutic Area: Oncology Brand Name: BBO-10203

Study Phase: Phase IProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 30, 2024

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01

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Lead Product(s) : BBO-10203,Trastuzumab

Therapeutic Area : Oncology

Highest Development Status : Phase I

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : BBO-10203 is a first-in-class orally bioavailable RAS:PI3Ka breaker that blocks the interaction between RAS and PI3Kα to inhibit PI3Kα-AKT signaling in tumors.

Brand Name : BBO-10203

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 30, 2024

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Details:

HLX11 (pertuzumab biosimilar) is the HER2 humanized monoclonal antibody, which is being investigated for the treatment of HER2-positive/ HR-negative locally advanced breast cancer.


Lead Product(s): Pertuzumab,Trastuzumab,Docetaxel

Therapeutic Area: Oncology Brand Name: HLX11

Study Phase: Phase IIIProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 30, 2024

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02

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Details : HLX11 (pertuzumab biosimilar) is the HER2 humanized monoclonal antibody, which is being investigated for the treatment of HER2-positive/ HR-negative locally advanced breast cancer.

Brand Name : HLX11

Molecule Type : Large molecule

Upfront Cash : Not Applicable

September 30, 2024

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Details:

Hercessi (trastuzumab-biosimilar) is biosimilar to Herceptin, which is indicatedfor the treatment of HER2 overexpressing breast cancer & metastatic gastric or gastroesophageal junction adenocarcinoma.


Lead Product(s): Trastuzumab

Therapeutic Area: Oncology Brand Name: Hercessi

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 18, 2024

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03

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Details : Hercessi (trastuzumab-biosimilar) is biosimilar to Herceptin, which is indicatedfor the treatment of HER2 overexpressing breast cancer & metastatic gastric or gastroesophageal junction adenocarcinoma.

Brand Name : Hercessi

Molecule Type : Large molecule

Upfront Cash : Not Applicable

September 18, 2024

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Details:

ALX148 (evorpacept) is a next generation CD47 blocker, which is being investigated in combination with trastuzumab in patients with HER2-positive gastric/gastroesophageal junction (“GEJ”) cancer.


Lead Product(s): Evorpacept,Trastuzumab,Ramucirumab

Therapeutic Area: Oncology Brand Name: ALX148

Study Phase: Phase II/ Phase IIIProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 31, 2024

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04

ALX Oncology

U.S.A
arrow
CPHI Middle east
Not Confirmed

ALX Oncology

U.S.A
arrow
CPHI Middle east
Not Confirmed

Details : ALX148 (evorpacept) is a next generation CD47 blocker, which is being investigated in combination with trastuzumab in patients with HER2-positive gastric/gastroesophageal junction (“GEJ”) cancer.

Brand Name : ALX148

Molecule Type : Large molecule

Upfront Cash : Not Applicable

July 31, 2024

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Details:

Tuznue (trastuzumab-biosimilar) is a HER2/neu receptor antagonist, which is indicatedfor the treatment of HER2 overexpressing breast cancer & metastatic gastric adenocarcinoma.


Lead Product(s): Trastuzumab,Docetaxel,Epirubicin Hydrochloride

Therapeutic Area: Oncology Brand Name: Tuznue

Study Phase: Phase IIIProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 31, 2024

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05

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Details : Tuznue (trastuzumab-biosimilar) is a HER2/neu receptor antagonist, which is indicatedfor the treatment of HER2 overexpressing breast cancer & metastatic gastric adenocarcinoma.

Brand Name : Tuznue

Molecule Type : Large molecule

Upfront Cash : Not Applicable

July 31, 2024

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Details:

Mamitra, biosimilar of trastuzumab, is an anti-HER2 antibody-drug conjugate (ADC) which is being developed for HER2-positive unresectable locally advanced or metastatic breast cancer (MBC).


Lead Product(s): Trastuzumab

Therapeutic Area: Oncology Brand Name: Mamitra

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 31, 2024

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06

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Details : Mamitra, biosimilar of trastuzumab, is an anti-HER2 antibody-drug conjugate (ADC) which is being developed for HER2-positive unresectable locally advanced or metastatic breast cancer (MBC).

Brand Name : Mamitra

Molecule Type : Large molecule

Upfront Cash : Not Applicable

July 31, 2024

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Details:

The proceeds from the financing will be used to advance the IAM1363, a highly selective, brain-penetrant small molecule inhibitor, being evaluated for the treatment of HER2-mutated neoplasms.


Lead Product(s): IAM1363,Trastuzumab

Therapeutic Area: Oncology Brand Name: IAM1363

Study Phase: Phase IProduct Type: Small molecule

Sponsor: Mubadala Capital

Deal Size: $150.0 million Upfront Cash: Undisclosed

Deal Type: Series B Financing June 18, 2024

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CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Lead Product(s) : IAM1363,Trastuzumab

Therapeutic Area : Oncology

Highest Development Status : Phase I

Partner/Sponsor/Collaborator : Mubadala Capital

Deal Size : $150.0 million

Deal Type : Series B Financing

Details : The proceeds from the financing will be used to advance the IAM1363, a highly selective, brain-penetrant small molecule inhibitor, being evaluated for the treatment of HER2-mutated neoplasms.

Brand Name : IAM1363

Molecule Type : Small molecule

Upfront Cash : Undisclosed

June 18, 2024

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Details:

Keytruda (pembrolizumab) is a USFDA approved anti PD-L1 monoclonal antibody. It is being evaluated in combination with trastuzumab for HER2-positive advanced gastroesophageal junction adenocarcinoma.


Lead Product(s): Pembrolizumab,Trastuzumab,Cisplatin

Therapeutic Area: Oncology Brand Name: Keytruda

Study Phase: Phase IIIProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 01, 2024

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08

Merck & Co

U.S.A
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CPHI Middle east
Not Confirmed

Merck & Co

U.S.A
arrow
CPHI Middle east
Not Confirmed

Details : Keytruda (pembrolizumab) is a USFDA approved anti PD-L1 monoclonal antibody. It is being evaluated in combination with trastuzumab for HER2-positive advanced gastroesophageal junction adenocarcinoma.

Brand Name : Keytruda

Molecule Type : Large molecule

Upfront Cash : Not Applicable

May 01, 2024

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Details:

Hercessi (trastuzumab-biosimilar) is a HER2/neu receptor antagonist, which is indicated for HER2 overexpressing breast cancer & metastatic gastric or gastroesophageal junction adenocarcinoma.


Lead Product(s): Trastuzumab

Therapeutic Area: Oncology Brand Name: Hercessi

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 29, 2024

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09

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Details : Hercessi (trastuzumab-biosimilar) is a HER2/neu receptor antagonist, which is indicated for HER2 overexpressing breast cancer & metastatic gastric or gastroesophageal junction adenocarcinoma.

Brand Name : Hercessi

Molecule Type : Large molecule

Upfront Cash : Not Applicable

April 29, 2024

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Details:

The partnership seeks to enhance the commercialization efforts of Ogivri (trastuzumab), an FDA-approved biosimilar utilized in patients diagnosed with breast cancer or metastatic stomach cancer.


Lead Product(s): Trastuzumab

Therapeutic Area: Oncology Brand Name: Ogivri

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Sandoz B2B

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership February 10, 2024

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CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Details : The partnership seeks to enhance the commercialization efforts of Ogivri (trastuzumab), an FDA-approved biosimilar utilized in patients diagnosed with breast cancer or metastatic stomach cancer.

Brand Name : Ogivri

Molecule Type : Large molecule

Upfront Cash : Undisclosed

February 10, 2024

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FDF Dossiers

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01

Celltrion

South Korea
CPHI Middle east
Not Confirmed
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Celltrion

South Korea
arrow
CPHI Middle east
Not Confirmed

trastuzumab

Brand Name : Herzuma

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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CPHI Middle east
Not Confirmed
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CPHI Middle east
Not Confirmed

Trastuzumab

Brand Name : Trastuzumab Cipla 440 mg

Dosage Form : INJ

Dosage Strength : 440mg

Packaging : 21X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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F. Hoffmann-La Roche

Switzerland
CPHI Middle east
Not Confirmed
arrow

F. Hoffmann-La Roche

Switzerland
arrow
CPHI Middle east
Not Confirmed

trastuzumab

Brand Name : Herceptin

Dosage Form : POWDER FOR CONCENTRATE FOR

Dosage Strength : 150 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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04

F. Hoffmann-La Roche

Switzerland
CPHI Middle east
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
arrow
CPHI Middle east
Not Confirmed

Trastuzumab

Brand Name : Herceptin 21 mg/ml IV

Dosage Form : INJ

Dosage Strength : 440mg

Packaging : 21X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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F. Hoffmann-La Roche

Switzerland
CPHI Middle east
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
arrow
CPHI Middle east
Not Confirmed

trastuzumab

Brand Name : Herceptin SC

Dosage Form : injection

Dosage Strength : 600 mg/5 mL

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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CPHI Middle east
Not Confirmed
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CPHI Middle east
Not Confirmed

trastuzumab

Brand Name : Kanjinti

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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CPHI Middle east
Not Confirmed
arrow
arrow
CPHI Middle east
Not Confirmed

trastuzumab

Brand Name : Kanjinti

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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08

CPHI Middle east
Not Confirmed
arrow
arrow
CPHI Middle east
Not Confirmed

trastuzumab

Brand Name : Kanjinti

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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09

CPHI Middle east
Not Confirmed
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CPHI Middle east
Not Confirmed

trastuzumab

Brand Name : Trazimera

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Sandoz B2B

Switzerland
CPHI Middle east
Not Confirmed
arrow

Sandoz B2B

Switzerland
arrow
CPHI Middle east
Not Confirmed

trastuzumab

Brand Name : Ogivri

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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FDA Orange Book

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01

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

TRASTUZUMAB-STRF

Brand Name : HERCESSI

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 150MG

Approval Date :

Application Number : 761346

RX/OTC/DISCN :

RLD :

TE Code :

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AMGEN INC

U.S.A
Antibody Engineering
Not Confirmed
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AMGEN INC

U.S.A
arrow
Antibody Engineering
Not Confirmed

TRASTUZUMAB-ANNS

Brand Name : KANJINTI

Dosage Form : VIAL; MULTIDOSE

Dosage Strength : 420MG

Approval Date :

Application Number : 761073

RX/OTC/DISCN :

RLD :

TE Code :

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AMGEN INC

U.S.A
Antibody Engineering
Not Confirmed
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AMGEN INC

U.S.A
arrow
Antibody Engineering
Not Confirmed

TRASTUZUMAB-ANNS

Brand Name : KANJINTI

Dosage Form : VIAL;SINGLE-DOSE

Dosage Strength : 150MG

Approval Date :

Application Number : 761073

RX/OTC/DISCN :

RLD :

TE Code :

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CELLTRION INC

South Korea
Antibody Engineering
Not Confirmed
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CELLTRION INC

South Korea
arrow
Antibody Engineering
Not Confirmed

TRASTUZUMAB-PKRB

Brand Name : HERZUMA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 420MG

Approval Date :

Application Number : 761091

RX/OTC/DISCN :

RLD :

TE Code :

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GENENTECH

U.S.A
Antibody Engineering
Not Confirmed
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GENENTECH

U.S.A
arrow
Antibody Engineering
Not Confirmed

TRASTUZUMAB

Brand Name : HERCEPTIN

Dosage Form : VIAL; INTRAVENOUS

Dosage Strength : 21MG/ML

Approval Date :

Application Number : 103792

RX/OTC/DISCN :

RLD :

TE Code :

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PFIZER INC

U.S.A
Antibody Engineering
Not Confirmed
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PFIZER INC

U.S.A
arrow
Antibody Engineering
Not Confirmed

TRASTUZUMAB-QYYP

Brand Name : TRAZIMERA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 420MG

Approval Date :

Application Number : 761081

RX/OTC/DISCN :

RLD :

TE Code :

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Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

TRASTUZUMAB-DTTB

Brand Name : ONTRUZANT

Dosage Form : POWDER;IV (INFUSION)

Dosage Strength : 150MG

Approval Date :

Application Number : 761100

RX/OTC/DISCN :

RLD :

TE Code :

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Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

TRASTUZUMAB-DTTB

Brand Name : ONTRUZANT

Dosage Form : POWDER;IV (INFUSION)

Dosage Strength : 420MG

Approval Date :

Application Number : 761100

RX/OTC/DISCN :

RLD :

TE Code :

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MYLAN GMBH

U.S.A
Antibody Engineering
Not Confirmed
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MYLAN GMBH

U.S.A
arrow
Antibody Engineering
Not Confirmed

TRASTUZUMAB-DKST

Brand Name : OGIVRI

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 420MG/VIAL

Approval Date :

Application Number : 761074

RX/OTC/DISCN :

RLD :

TE Code :

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Europe

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01

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Trastuzumabum deruxtecanum

Brand Name : Enhertu

Dosage Form : Inf Conc

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

trastuzumab

Brand Name : Herceptin

Dosage Form : SOLUTION FOR INJECTION

Dosage Strength : 600 MG / 5 ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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Antibody Engineering
Not Confirmed
arrow
arrow
Antibody Engineering
Not Confirmed

trastuzumab

Brand Name : Herceptin

Dosage Form : SOLUTION FOR INJECTION IN

Dosage Strength : 600 MG / 5 ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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04

Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

trastuzumab

Brand Name : Herceptin

Dosage Form : POWDER FOR CONCENTRATE FOR

Dosage Strength : 150 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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05

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Trastuzumab

Brand Name : Herceptin

Dosage Form : Trastuzumab 150Mg 1 Unit Parenteral Use

Dosage Strength : 1 vial groun EV 150 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Trastuzumab

Brand Name : Herceptin

Dosage Form : Trastuzumab 600Mg 1 Unit Parenteral Use

Dosage Strength : 1 vial SC 600 mg/5 ml 6 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Pertuzumabum; Trastuzumabum

Brand Name : Phesgo

Dosage Form : Inj L?s

Dosage Strength : 1200mg/600mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

Pertuzumabum; Trastuzumabum

Brand Name : Phesgo

Dosage Form : Inj L?s

Dosage Strength : 600mg/600mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Canada

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01

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

TRASTUZUMAB

Brand Name : KANJINTI

Dosage Form : KIT

Dosage Strength : 420MG/VIAL

Packaging :

Approval Date :

Application Number : 2496690

Regulatory Info : Prescription

Registration Country : Canada

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Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

TRASTUZUMAB

Brand Name : HERZUMA

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 150MG/VIAL

Packaging :

Approval Date :

Application Number : 2506211

Regulatory Info : Prescription

Registration Country : Canada

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03

Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

TRASTUZUMAB

Brand Name : HERZUMA

Dosage Form : KIT

Dosage Strength : 440MG/VIAL

Packaging :

Approval Date :

Application Number : 2480794

Regulatory Info : Prescription

Registration Country : Canada

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Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

TRASTUZUMAB

Brand Name : HERCEPTIN SC

Dosage Form : SOLUTION

Dosage Strength : 600MG/5ML

Packaging :

Approval Date :

Application Number : 2480697

Regulatory Info : Prescription

Registration Country : Canada

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Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

TRASTUZUMAB

Brand Name : PHESGO

Dosage Form : SOLUTION

Dosage Strength : 40MG/ML

Packaging :

Approval Date :

Application Number : 2512912

Regulatory Info : Prescription

Registration Country : Canada

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Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

TRASTUZUMAB

Brand Name : PHESGO

Dosage Form : SOLUTION

Dosage Strength : 60MG/ML

Packaging :

Approval Date :

Application Number : 2512920

Regulatory Info : Prescription

Registration Country : Canada

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07

Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

TRASTUZUMAB

Brand Name : TRAZIMERA

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 440MG/VIAL

Packaging :

Approval Date :

Application Number : 2483467

Regulatory Info : Prescription

Registration Country : Canada

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08

Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

TRASTUZUMAB

Brand Name : ONTRUZANT

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 150MG/VIAL

Packaging :

Approval Date :

Application Number : 2524317

Regulatory Info : Prescription

Registration Country : Canada

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09

Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

TRASTUZUMAB

Brand Name : ONTRUZANT

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 440MG/VIAL

Packaging :

Approval Date :

Application Number : 2524325

Regulatory Info : Prescription

Registration Country : Canada

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BIOSIMILAR COLLABORATIONS IRELAND LIMITE...

Country
Antibody Engineering
Not Confirmed
arrow

BIOSIMILAR COLLABORATIONS IRELAND LIMITE...

Country
arrow
Antibody Engineering
Not Confirmed

TRASTUZUMAB

Brand Name : OGIVRI

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 150MG/VIAL

Packaging :

Approval Date :

Application Number : 2474425

Regulatory Info : Prescription

Registration Country : Canada

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Australia

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01

Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

trastuzumab

Brand Name : Herzuma

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

trastuzumab

Brand Name : Herzuma

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

trastuzumab

Brand Name : Herzuma

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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04

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

trastuzumab

Brand Name : Herzuma

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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05

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

trastuzumab

Brand Name : Herzuma

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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06

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

trastuzumab

Brand Name : Kanjinti

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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07

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

trastuzumab

Brand Name : Trazimera

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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08

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

trastuzumab

Brand Name : Trazimera

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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09

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

trastuzumab

Brand Name : Trazimera

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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10

Sandoz Pty Ltd

Switzerland
Antibody Engineering
Not Confirmed
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Sandoz Pty Ltd

Switzerland
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Antibody Engineering
Not Confirmed

trastuzumab

Brand Name : Ogivri

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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South Africa

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01

Cipla Medpro (Pty) Ltd

South Africa
Antibody Engineering
Not Confirmed
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Cipla Medpro (Pty) Ltd

South Africa
arrow
Antibody Engineering
Not Confirmed

Trastuzumab

Brand Name : Trastuzumab Cipla 440 mg

Dosage Form : INJ

Dosage Strength : 440mg

Packaging : 21X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

trastuzumab

Brand Name : Phesgo FDC 1200

Dosage Form : SOL

Dosage Strength : 600mg

Packaging : 15X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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03

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

trastuzumab

Brand Name : Phesgo FDC 600

Dosage Form : SOL

Dosage Strength : 600mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Trastuzumab

Brand Name : Herceptin SC 600mg

Dosage Form : INJ

Dosage Strength : 600mg/5ml

Packaging : 5X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Trastuzumab

Brand Name : Herceptin 21 mg/ml IV

Dosage Form : INJ

Dosage Strength : 440mg

Packaging : 21X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Trastuzumab

Brand Name : OGIVRI 440

Dosage Form : INJ

Dosage Strength : 440mg

Packaging : 21X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Listed Dossiers

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01

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Trastuzumab

Brand Name : AryoTrust

Dosage Form : Injectable

Dosage Strength : 150MG

Packaging : Vial

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Iran

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01

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Trastuzumab

Dosage : Injectable

Dosage Strength : 150MG

Brand Name : AryoTrust

Approval Date :

Application Number :

Registration Country : Iran

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02

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Trastuzumab

Brand Name : AryoTrust

Dosage Form : Injectable

Dosage Strength : 440MG

Packaging : Vial

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Iran

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02

Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

Trastuzumab

Dosage : Injectable

Dosage Strength : 440MG

Brand Name : AryoTrust

Approval Date :

Application Number :

Registration Country : Iran

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