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List of Drug Master Files (DMF) of Irinotecan Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

Irinotecan
7-Ethyl-10-Hydroxycamptothecin
Cetuximab
SN38
USDMF

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Irinotecan

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

61 API Suppliers, 32 USDMF, 12 CEP/COS, 9 JDMF, 7 EU WC, 13 KDMF, 12 NDC API, 35 Listed Suppliers, $ API Reference Price

61 API Suppliers
32 USDMF
12 CEP/COS
9 JDMF
7 EU WC
13 KDMF
12 NDC API
35 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

70 Drugs in Development

70 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

INTERMEDIATES

19 API Suppliers

19 API Suppliers

FINISHED DOSAGE FORMULATIONS

217 FDF Dossiers, 65 FDA Orange Book, 93 Europe, 7 Canada, 14 Australia, 16 South Africa, 22 Listed Dossiers

217 FDF Dossiers
65 FDA Orange Book
93 Europe
7 Canada
14 Australia
16 South Africa
22 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 100MG/5ML (20MG/ML), INJECTABLE;INJECTION - 300MG/15ML (20MG/ML), INJECTABLE;INJECTION - 40MG/2ML (20MG/ML), INJECTABLE, LIPOSOMAL;INTRAVENOUS - EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)

INJECTABLE;INJECTION - 100MG/5ML (20MG/ML)
INJECTABLE;INJECTION - 300MG/15ML (20MG/ML)
INJECTABLE;INJECTION - 40MG/2ML (20MG/ML)
INJECTABLE, LIPOSOMAL;INTRAVENOUS - EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 2 SPI Pharma, 4 Nippon Fine Chemical, 1 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 3 Actylis, 1 BioSpectra, 11 Roquette, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Zhejiang Huakang Pharmaceutical

1 Rochem International Inc
2 SPI Pharma
4 Nippon Fine Chemical
1 Gangwal Healthcare
1 Nanjing Well Pharmaceutical
3 Actylis
1 BioSpectra
11 Roquette
1 Shijiazhuang Huaxu Pharmaceutical
1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

9 Film Formers & Plasticizers, 7 Parenteral, 4 Fillers, Diluents & Binders, 4 Taste Masking, 4 Coating Systems & Additives, 3 Surfactant & Foaming Agents, 2 Chewable & Orodispersible Aids, 2 Emulsifying Agents, 2 Topical, 2 Co-Processed Excipients, 1 Soft Gelatin, 1 Direct Compression, 1 Thickeners and Stabilizers, 1 Solubilizers, 1 Dry Powder Inhalation

9 Film Formers & Plasticizers
7 Parenteral
4 Fillers, Diluents & Binders
4 Taste Masking
4 Coating Systems & Additives
3 Surfactant & Foaming Agents
2 Chewable & Orodispersible Aids
2 Emulsifying Agents
2 Topical
2 Co-Processed Excipients
1 Soft Gelatin
1 Direct Compression
1 Thickeners and Stabilizers
1 Solubilizers
1 Dry Powder Inhalation

DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 62 NEWS #PharmaBuzz

5 DATA COMPILATION #PharmaFlow
62 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 66 Finished Drug Prices, 7 Annual Reports

2 US Medicaid Prescriptions
66 Finished Drug Prices
7 Annual Reports

MARKET PLACE

7 APIs, 9 FDF Dossiers

7 APIs
9 FDF Dossiers

PATENTS & EXCLUSIVITIES

22 US Patents, 2 US Exclusivities, 3 Health Canada Patents

22 US Patents
2 US Exclusivities
3 Health Canada Patents

REF. STANDARDS & IMPURITIES

6 USP, 7 Others

6 USP
7 Others

$ API Ref.Price (USD/KG) : 21,906 Xls

Filters

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32 All

01 1Fermion Oy

02 1ALP Pharm

03 1Arch Pharmalabs

04 1Benzo Chem Industries Pvt. Ltd.

05 1Charioteer

06 1Cipla

07 1Emcure Pharmaceuticals

08 1Fresenius Kabi AB Brunna

09 1Hetero Drugs

10 1Hubei Haosun Pharmaceutical Co., Ltd.

11 1JARI Pharmaceutical

12 1Jiangsu Hengrui Medicine

13 1Laurus Labs

14 1Mac-Chem Products (India) Pvt.Ltd

15 1Olon S.p.A

16 1Pliva Hrvatska

17 2Polymed Therapeutics Inc.

18 1Qilu Pharmaceutical

19 1Sai Phytoceuticals

20 2ScinoPharm Taiwan, Ltd

21 1Shilpa Medicare

22 1Sichuan Xieli Pharmaceutical

23 3Sun Pharmaceutical Industries Limited

24 1Terumo

25 2YAKULT HONSHA CO LTD

26 1Zhejiang Hisun Pharmaceutical

27 1Zydus Lifesciences

filter Subject Reset all filters

32 All

01 1CPT-11

02 1IHL- 305 IRINOTECAN LIPOSOME INJECTION

03 1IRINOTECAN HCL

04 5IRINOTECAN HYDROCHLORIDE

05 1IRINOTECAN HYDROCHLORIDE (NON STERILE, API)

06 8IRINOTECAN HYDROCHLORIDE TRIHYDRATE

07 1IRINOTECAN HYDROCHLORIDE TRIHYDRATE (NON-STERILE BULK) DRUG SUBSTANCE

08 5IRINOTECAN HYDROCHLORIDE TRIHYDRATE USP

09 1IRINOTECAN HYDROCHLORIDE TRIHYDRATE, USP (FORM B)

10 4IRINOTECAN HYDROCHLORIDE USP

11 1IRINOTECAN HYDROCHLORIDE USP (NON-STERILE BULK) DRUG SUBSTANCE

12 1IRINOTICAN HYDROCHLORIDE

13 1SN38

14 1TOTAL SYNTHESIS OF TSN-38B-11 INTERMEDIATE COMPOUND USED IN THE MANUFACTURE OF IRINOTECAN HYDROCHLORIDE TRIHYRATE (CPT-11) DRUG SUBSTANCE

filter Country Reset all filters

32 All

01 8China

02 1Croatia

03 1Finland

04 13India

05 1Italy

06 3Japan

07 1Sweden

08 2Taiwan

09 2U.S.A

filter Status Reset all filters

32 All

01 17Active

02 15Inactive

filter GDUFA DMF Review Reset all filters

32 All

01 8Complete

02 24Blank

Cohance Irinotecan Hydrochloride Popup

API Suppliers
USDMF
CEP/COS
JDMF
EU WC
KDMF
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Fermion Oy

CPhI Worldwide, Milan

With Fermion, start the journey of your innovative API.

Contact Supplier

Contact Supplier

Digital Content

Irinotecan Hydrochloride

GDUFA

DMF Review : Complete

Rev. Date : 2013-09-14

Pay. Date : 2013-09-05

DMF Number : 20649

Submission : 2007-06-29

Status : Active

Type : II

Product Web Link

Digital Content

02

Emcure Pharmaceuticals Ltd

USDMF

Discovery on Target

Not Confirmed

02

Emcure Pharmaceuticals Ltd

Discovery on Target

Not Confirmed

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Digital Content

Irinotecan Hydrochloride Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 23220

Submission : 2009-10-27

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

03

Hubei Haosun Pharmaceutical Co Ltd

USDMF

Discovery on Target

Not Confirmed

03

Hubei Haosun Pharmaceutical Co Ltd

Discovery on Target

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Irinotecan Hydrochloride

GDUFA

DMF Review : Complete

Rev. Date : 2015-09-28

Pay. Date : 2015-09-22

DMF Number : 23522

Submission : 2010-01-10

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Jiangsu Hengrui Pharmaceuticals Co L...

USDMF

Discovery on Target

Not Confirmed

04

Jiangsu Hengrui Pharmaceuticals Co L...

Discovery on Target

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Irinotecan Hydrochloride Usp (non-sterile Bulk...

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 20739

Submission : 2007-08-01

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Laurus Labs Ltd

USDMF

Discovery on Target

Not Confirmed

05

Laurus Labs Ltd

Discovery on Target

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

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Digital Content

Irinotecan Hydrochloride Trihydrate Usp

GDUFA

DMF Review : Complete

Rev. Date : 2018-11-02

Pay. Date : 2018-10-31

DMF Number : 22296

Submission : 2008-11-21

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

06

Olon Spa

USDMF

Discovery on Target

Not Confirmed

06

Olon Spa

Discovery on Target

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Irinotecan Hydrochloride Trihydrate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 21500

Submission : 2008-03-29

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

07

Pliva-lachema As

USDMF

Discovery on Target

Not Confirmed

07

Pliva-lachema As

Discovery on Target

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Irinotecan Hydrochloride Trihydrate

GDUFA

DMF Review : Complete

Rev. Date : 2012-11-23

Pay. Date : 2012-11-09

DMF Number : 19050

Submission : 2005-12-20

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Scinopharm Taiwan Ltd

USDMF

Discovery on Target

Not Confirmed

08

Scinopharm Taiwan Ltd

Discovery on Target

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

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Digital Content

Sn38

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 21183

Submission : 2007-12-25

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

09

Scinopharm Taiwan Ltd

USDMF

Discovery on Target

Not Confirmed

09

Scinopharm Taiwan Ltd

Discovery on Target

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Irinotecan Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17312

Submission : 2004-04-20

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

10

Sichuan Xieli Pharmaceutical Co Ltd

USDMF

Discovery on Target

Not Confirmed

10

Sichuan Xieli Pharmaceutical Co Ltd

Discovery on Target

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Irinotecan Hcl

GDUFA

DMF Review : Complete

Rev. Date : 2018-12-21

Pay. Date : 2018-11-16

DMF Number : 21713

Submission : 2008-06-10

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

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Last

Irinotecan Manufacturers | Traders | Suppliers

Irinotecan Manufacturers, Traders, Suppliers 1

84

We have 27 companies offering Irinotecan

Get in contact with the supplier of your choice:

Fermion Oy
ALP Pharm
Arch Pharmalabs
Benzo Chem Industries Pvt. Ltd.
Charioteer
Cipla
Emcure Pharmaceuticals
Fresenius Kabi AB Brunna
Hetero Drugs
Hubei Haosun Pharmaceutical Co., Ltd.
JARI Pharmaceutical
Jiangsu Hengrui Medicine
Laurus Labs
Mac-Chem Products (India) Pvt.Ltd
Olon S.p.A
Pliva Hrvatska
Polymed Therapeutics Inc.
Qilu Pharmaceutical
Sai Phytoceuticals
ScinoPharm Taiwan, Ltd
Shilpa Medicare
Sichuan Xieli Pharmaceutical
Sun Pharmaceutical Industries Limited
Terumo
YAKULT HONSHA CO LTD
Zhejiang Hisun Pharmaceutical
Zydus Lifesciences

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