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26 RELATED EXCIPIENT COMPANIES

46EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 88755-39-9, Chembl2000337, Runx1/eto tetramerization-in-1, Nsc162496, Schembl16211954, Dtxsid40864143
Molecular Formula
C18H14O7
Molecular Weight
342.3  g/mol
InChI Key
PPEBBOHQEAQKSW-UHFFFAOYSA-N

Hyaluronidase
1 2D Structure

Hyaluronidase

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2,4-bis(1,3-benzodioxol-5-yl)-4-oxobutanoic acid
2.1.2 InChI
InChI=1S/C18H14O7/c19-13(11-2-4-15-17(6-11)25-9-23-15)7-12(18(20)21)10-1-3-14-16(5-10)24-8-22-14/h1-6,12H,7-9H2,(H,20,21)
2.1.3 InChI Key
PPEBBOHQEAQKSW-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1OC2=C(O1)C=C(C=C2)C(CC(=O)C3=CC4=C(C=C3)OCO4)C(=O)O
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. 88755-39-9

2. Chembl2000337

3. Runx1/eto Tetramerization-in-1

4. Nsc162496

5. Schembl16211954

6. Dtxsid40864143

7. Bdbm50392853

8. 2,3]dioxol-5-yl)-4-oxobutanoic Acid

9. Nsc-162496

10. Hy-151411

11. Cs-0611487

12. Ft-0627100

13. A937131

14. Butanoic Acid,4-bis[1,3-benzodioxol-5-yl]-4-oxo-

15. 2,4-bis(2h-1,3-benzodioxol-5-yl)-4-oxobutanoic Acid

2.3 Create Date
2005-03-26
3 Chemical and Physical Properties
Molecular Weight 342.3 g/mol
Molecular Formula C18H14O7
XLogP32.4
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count7
Rotatable Bond Count5
Exact Mass342.07395278 g/mol
Monoisotopic Mass342.07395278 g/mol
Topological Polar Surface Area91.3 Ų
Heavy Atom Count25
Formal Charge0
Complexity522
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

API SUPPLIERS

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01

SIGMA TAU

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPHI Middle east
Not Confirmed
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SIGMA TAU

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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CPHI Middle east
Not Confirmed
USDMF Inactive-api CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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02

Reliable Biopharmaceutical Corpora...

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPHI Middle east
Not Confirmed
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Reliable Biopharmaceutical Corpora...

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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CPHI Middle east
Not Confirmed
USDMF Inactive-api CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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03

Fujifilm Diosynth Biotechnologies

United Kingdom

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPHI Middle east
Not Confirmed
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Fujifilm Diosynth Biotechnologies

United Kingdom

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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CPHI Middle east
Not Confirmed
USDMF Inactive-api CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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04

SERAVAC BIOTECH PTY LTD

South Africa

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPHI Middle east
Not Confirmed
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SERAVAC BIOTECH PTY LTD

South Africa

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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CPHI Middle east
Not Confirmed
USDMF Inactive-api CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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05

SAFC

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPHI Middle east
Not Confirmed
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SAFC

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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CPHI Middle east
Not Confirmed
USDMF Inactive-api CEP/COS Inactive-api JDMF EU-WC NDC KDMF VMF Others AUDIT
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06

Worthington Biochemical Corporatio...

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPHI Middle east
Not Confirmed
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Worthington Biochemical Corporatio...

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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CPHI Middle east
Not Confirmed
USDMF Inactive-api CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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07

BBI Solutions

United Kingdom

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPHI Middle east
Not Confirmed
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BBI Solutions

United Kingdom

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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CPHI Middle east
Not Confirmed
USDMF CEP/COS arrow-down JDMF EU-WC NDC KDMF VMF Others AUDIT
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08

Avid Bioservices

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPHI Middle east
Not Confirmed
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Avid Bioservices

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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CPHI Middle east
Not Confirmed
USDMF CEP/COS JDMF arrow-down EU-WC NDC KDMF VMF Others AUDIT
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09

Sichuan Deebio Pharmaceutical Co.,...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPHI Middle east
Not Confirmed
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10

Bioindustria L.I.M. Spa

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPHI Middle east
Not Confirmed
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Bioindustria L.I.M. Spa

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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CPHI Middle east
Not Confirmed
USDMF CEP/COS Inactive-api JDMF EU-WC NDC KDMF VMF Others AUDIT
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USDMF

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Diosynth Bv

United Kingdom

USDMF

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DDL Conference
Not Confirmed

01

Diosynth Bv

United Kingdom
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DDL Conference
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 4489

Submission : 1982-02-02

Status : Inactive

Type : II

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02

DDL Conference
Not Confirmed

02

DDL Conference
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16273

Submission : 2002-11-25

Status : Inactive

Type : II

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03

DDL Conference
Not Confirmed

03

DDL Conference
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 26086

Submission : 2012-05-24

Status : Inactive

Type : II

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04

Seravac Biotech Pty Ltd

South Africa

USDMF

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DDL Conference
Not Confirmed

04

DDL Conference
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16622

Submission : 2003-05-30

Status : Inactive

Type : II

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05

Sigma F And D Div Ltd

U.S.A

USDMF

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DDL Conference
Not Confirmed

05

DDL Conference
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 3405

Submission : 1979-01-09

Status : Inactive

Type : II

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06

DDL Conference
Not Confirmed

06

DDL Conference
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 90

Submission : 1954-03-04

Status : Inactive

Type : II

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KDMF

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01

BMI Korea

South Korea
DDL Conference
Not Confirmed
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BMI Korea

South Korea
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DDL Conference
Not Confirmed

Hyaluronidase

Registrant Name : Korea BMI Co., Ltd.

Registration Date : 2023-12-27

Registration Number : 20231227-210-J-1591

Manufacturer Name : Korea BMI Co., Ltd.

Manufacturer Address : 11, Cheomdan-ro 7-gil, Jeju-si, Jeju Special Self-Governing Province, Factory 2

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02

Humedix

South Korea
DDL Conference
Not Confirmed
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Humedix

South Korea
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DDL Conference
Not Confirmed

Hyaluronidase

Registrant Name : Humedics Co., Ltd.

Registration Date : 2024-03-13

Registration Number : 20240313-210-J-1619

Manufacturer Name : Humedics Co., Ltd.

Manufacturer Address : 17 Biovalley 2-ro, Jecheon-si, Chungcheongbuk-do

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03

Humedix

South Korea
DDL Conference
Not Confirmed
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Humedix

South Korea
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DDL Conference
Not Confirmed

Hyaluronidase

Registrant Name : Humedics Co., Ltd.

Registration Date : 2024-03-13

Registration Number : 20240313-210-J-1620

Manufacturer Name : Humedics Co., Ltd.

Manufacturer Address : 17 Biovalley 2-ro, Jecheon-si, Chungcheongbuk-do

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04

DDL Conference
Not Confirmed
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DDL Conference
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Hyaluronidase

Registrant Name : Insung Trading Co., Ltd.

Registration Date : 2021-12-07

Registration Number : 20211207-210-J-1171

Manufacturer Name : Ningbo Linzyme Biosciences C...

Manufacturer Address : 8, Xingshun Road, Binhai New city, Xiaocaoe town, Yuyao

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05

DDL Conference
Not Confirmed
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DDL Conference
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Hyaluronidase

Registrant Name : Korea Chorus Co., Ltd.

Registration Date : 2023-07-04

Registration Number : 20230704-210-J-1516

Manufacturer Name : Ningbo Linzyme Biosciences C...

Manufacturer Address : 8, Xingshun Road, Binhai New City, Xiaocao'e Town, Yuyao@11, Geodudanji 1-gil, Dongna...

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06

DDL Conference
Not Confirmed
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DDL Conference
Not Confirmed

Hyaluronidase

Registrant Name : Korea BMI Co., Ltd.

Registration Date : 2024-09-02

Registration Number : 20240902-210-J-1684

Manufacturer Name : Korea BMI Co., Ltd.

Manufacturer Address : 11, Cheomdan-ro 7-gil, Jeju-si, Jeju Special Self-Governing Province

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Listed Suppliers

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01

CPHI Middle east
Not Confirmed
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CPHI Middle east
Not Confirmed

Hyaluronidase

About the Company : Bioindustria Laboratorio Italiano Medicinali L.I.M. S.p.A. has a long tradition in the pharmaceutical business and specializes in: large and small volume injectables with termin...

Bioindustria Laboratorio Italiano Medicinali L.I.M. S.p.A. has a long tradition in the pharmaceutical business and specializes in: large and small volume injectables with terminal sterilization or with aseptic process, lyophilised dosage forms, syrups, drops, tablets, capsules.
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02

CPHI Middle east
Not Confirmed
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CPHI Middle east
Not Confirmed

Hyaluronidase

About the Company : The company is a professional manufacturer of active biological extracts. We adhere to the market-oriented business philosophy. The international and domestic markets take advantag...

The company is a professional manufacturer of active biological extracts. We adhere to the market-oriented business philosophy. The international and domestic markets take advantage of China's abundant raw material resources to develop animal organ extracts. The company mainly produces trypsin and trypsin. , chymotrypsin, trypsin enzymes , pancreatic kallikrein, pepsin, elastase, sodium, cytochrome C, hemoglobin, bovine liver extract, chondroitin sulfate, and other products, marketing the United States, Germany, Japan, Korea, etc. Countries and regions have established good long-term partnerships with customers around the world.
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Drugs in Development

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Details:

Vyvgart Hytrulo, a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment, and recombinant human hyaluronidase PH20, It is being developed for CIDP.


Lead Product(s): Efgartigimod Alfa,Hyaluronidase

Therapeutic Area: Neurology Brand Name: Vyvgart Hytrulo

Study Phase: Phase IIProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 20, 2024

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01

Argenx

Netherlands
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CPHI Middle east
Not Confirmed

Argenx

Netherlands
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CPHI Middle east
Not Confirmed

Lead Product(s) : Efgartigimod Alfa,Hyaluronidase

Therapeutic Area : Neurology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Vyvgart Hytrulo, a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment, and recombinant human hyaluronidase PH20, It is being developed for CIDP.

Brand Name : Vyvgart Hytrulo

Molecule Type : Large molecule

Upfront Cash : Not Applicable

November 20, 2024

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Details:

Vyvgart Hytrulo, a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment and recombinant human hyaluronidase PH20, it is indicated for CIPD.


Lead Product(s): Efgartigimod Alfa,Hyaluronidase

Therapeutic Area: Neurology Brand Name: Vyvgart Hytrulo

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Zai Lab

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 11, 2024

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02

Argenx

Netherlands
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CPHI Middle east
Not Confirmed

Argenx

Netherlands
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CPHI Middle east
Not Confirmed

Details : Vyvgart Hytrulo, a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment and recombinant human hyaluronidase PH20, it is indicated for CIPD.

Brand Name : Vyvgart Hytrulo

Molecule Type : Large molecule

Upfront Cash : Not Applicable

November 11, 2024

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Details:

Darzalex Faspro (daratumumab and hyaluronidase-fihj) in is being investgated as monotherapy for the treatment of adult patients with high-risk smouldering multiple myeloma.


Lead Product(s): Daratumumab,Hyaluronidase

Therapeutic Area: Oncology Brand Name: Darzalex Faspro

Study Phase: Phase IIIProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 08, 2024

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03

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Details : Darzalex Faspro (daratumumab and hyaluronidase-fihj) in is being investgated as monotherapy for the treatment of adult patients with high-risk smouldering multiple myeloma.

Brand Name : Darzalex Faspro

Molecule Type : Large molecule

Upfront Cash : Not Applicable

November 08, 2024

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Details:

Argenx gains access to Halozyme's ENHANZE, a proprietary rHuPH20 enzyme for subcutaneous drug delivery, for six targets, including FcRn target, Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase).


Lead Product(s): Efgartigimod Alfa,Hyaluronidase

Therapeutic Area: Immunology Brand Name: Vyvgart Hytrulo

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Argenx

Deal Size: $370.0 million Upfront Cash: $30.0 million

Deal Type: Collaboration October 03, 2024

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04

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Details : Argenx gains access to Halozyme's ENHANZE, a proprietary rHuPH20 enzyme for subcutaneous drug delivery, for six targets, including FcRn target, Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase).

Brand Name : Vyvgart Hytrulo

Molecule Type : Large molecule

Upfront Cash : $30.0 million

October 03, 2024

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Details:

Talvey (talquetamab, CD3 targeting) with Darzalex Faspro (daratumumab and hyaluronidase, CD38 targeting) antibodies are being investigated in patients with relapsed or refractory multiple myeloma.


Lead Product(s): Talquetamab,Daratumumab,Hyaluronidase

Therapeutic Area: Oncology Brand Name: Talvey

Study Phase: Phase IIIProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 27, 2024

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05

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Details : Talvey (talquetamab, CD3 targeting) with Darzalex Faspro (daratumumab and hyaluronidase, CD38 targeting) antibodies are being investigated in patients with relapsed or refractory multiple myeloma.

Brand Name : Talvey

Molecule Type : Large molecule

Upfront Cash : Not Applicable

September 27, 2024

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Details:

Ocrevus Zunovo (ocrelizumab-hyaluronidase) is a humanised mAb-enzyme designed to target CD20-positive B cells, approved for the treatment of multiple sclerosis.


Lead Product(s): Ocrelizumab,Hyaluronidase

Therapeutic Area: Neurology Brand Name: Ocrevus Zunovo

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 13, 2024

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06

F. Hoffmann-La Roche

Switzerland
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CPHI Middle east
Not Confirmed

F. Hoffmann-La Roche

Switzerland
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CPHI Middle east
Not Confirmed

Details : Ocrevus Zunovo (ocrelizumab-hyaluronidase) is a humanised mAb-enzyme designed to target CD20-positive B cells, approved for the treatment of multiple sclerosis.

Brand Name : Ocrevus Zunovo

Molecule Type : Large molecule

Upfront Cash : Not Applicable

September 13, 2024

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Details:

Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone is approved in the U.S. for patients with newly diagnosed multiple myeloma.


Lead Product(s): Daratumumab,Hyaluronidase,Bortezomib

Therapeutic Area: Oncology Brand Name: Darzalex Faspro

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 30, 2024

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07

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Details : Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone is approved in the U.S. for patients with newly diagnosed multiple myeloma.

Brand Name : Darzalex Faspro

Molecule Type : Large molecule

Upfront Cash : Not Applicable

July 30, 2024

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Details:

Vyvgart Hytrulo, a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment, and recombinant human hyaluronidase PH20, It is being developed for CIDP.


Lead Product(s): Efgartigimod Alfa,Hyaluronidase

Therapeutic Area: Neurology Brand Name: Vyvgart Hytrulo

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 21, 2024

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08

Argenx

Netherlands
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CPHI Middle east
Not Confirmed

Argenx

Netherlands
arrow
CPHI Middle east
Not Confirmed

Lead Product(s) : Efgartigimod Alfa,Hyaluronidase

Therapeutic Area : Neurology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Vyvgart Hytrulo, a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment, and recombinant human hyaluronidase PH20, It is being developed for CIDP.

Brand Name : Vyvgart Hytrulo

Molecule Type : Large molecule

Upfront Cash : Not Applicable

June 21, 2024

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Details:

Darzalex Faspro (daratumumab and hyaluronidase-fihj) with bortezomib, lenalidomide, and dexamethasone is evaluated in phase 3 trials for maintenance in newly diagnosed myeloma.


Lead Product(s): Daratumumab,Hyaluronidase,Lenalidomide

Therapeutic Area: Oncology Brand Name: Darzalex Faspro

Study Phase: Phase IIIProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 30, 2024

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09

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Details : Darzalex Faspro (daratumumab and hyaluronidase-fihj) with bortezomib, lenalidomide, and dexamethasone is evaluated in phase 3 trials for maintenance in newly diagnosed myeloma.

Brand Name : Darzalex Faspro

Molecule Type : Large molecule

Upfront Cash : Not Applicable

January 30, 2024

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Details:

Hyqvia is a liquid medicine containing Recombinant Human Hyaluronidase and immunoglobulins. It is approved as maintenance therapy in patients with chronic inflammatory demyelinating polyneuropathy.


Lead Product(s): Immune Globulin,Hyaluronidase

Therapeutic Area: Neurology Brand Name: HyQvia

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 29, 2024

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10

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Lead Product(s) : Immune Globulin,Hyaluronidase

Therapeutic Area : Neurology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Hyqvia is a liquid medicine containing Recombinant Human Hyaluronidase and immunoglobulins. It is approved as maintenance therapy in patients with chronic inflammatory demyelinating polyneuropathy.

Brand Name : HyQvia

Molecule Type : Large molecule

Upfront Cash : Not Applicable

January 29, 2024

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02

Pfanstiehl

U.S.A
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Medlab Asia & Asia Health
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

Grade : Parenteral

Category : Parenteral

Brand Name : L-Histidine

Excipient Details : Histidine is used in biotherapeutic formulations and protects monoclonal antibodies in both the liquid and lyophilized state.

Pharmacopoeia Ref : USP, EP, BP, JP, ChP

Technical Specs : pH 7.4

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05

Finar

India
Medlab Asia & Asia Health
Not Confirmed
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