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erlotinib HCl

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ACTIVE PHARMA INGREDIENTS

68 API Suppliers, 28 USDMF, 1 JDMF, 16 EU WC, 15 KDMF, 15 NDC API, 29 Listed Suppliers, $ API Reference Price

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

70 FDF Dossiers, 41 FDA Orange Book, 3 Europe, 11 Canada, 11 South Africa, 4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 4 DKSH, 3 Faran Shimi Pharmaceutical, 4 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 5 BASF, 10 Corel Pharma Chem, 5 DFE Pharma, 5 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 29 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 11 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 2 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives, 39 Fillers, Diluents & Binders, 20 Controlled & Modified Release, 14 Granulation, 14 Disintegrants & Superdisintegrants, 13 Direct Compression, 13 Thickeners and Stabilizers, 12 Lubricants & Glidants, 7 Film Formers & Plasticizers, 7 Co-Processed Excipients, 6 Taste Masking, 5 Empty Capsules, 4 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 3 Chewable & Orodispersible Aids, 3 API Stability Enhancers, 2 Emulsifying Agents, 1 Solubilizers, 1 Topical, 1 Parenteral, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

12 News #PharmaBuzz

12 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 3 Regulatory FDF Prices

MARKET PLACE

3 APIs, 1 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 Others

1 Others

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/03/2025	TAPI Technology & API Services	Israel	TEVA PHARMACEUTICAL INDUSTRIES LTD	23183	ERLOTINIB HCL	2009-10-16	Active	II	Complete	2012-11-23	2012-11-08
28/03/2025	Acebright India Pharma Private Limited	India	CDYMAX (INDIA) PHARMA PRIVATE LTD	33226	ERLOTINIB HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE)	2018-09-29	Active	II	N/A

Erlotinib HCl

erlotinib HCl

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

68 API Suppliers

28 USDMF

1 JDMF

16 EU WC

15 KDMF

15 NDC API

29 Listed Suppliers

$ API Reference Price

INTERMEDIATES

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

70 FDF Dossiers

41 FDA Orange Book

3 Europe

11 Canada

11 South Africa

4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma

4 DKSH

3 Faran Shimi Pharmaceutical

4 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

1 ACG Worldwide

4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

5 BASF

10 Corel Pharma Chem

5 DFE Pharma

5 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

1 Ingredion Pharma Solutions

29 Kerry

3 Kima Chemical

6 Lonza Capsugel

10 Microlex e.U

1 Novo Excipients

2 Pharmatrans-Sanaq

3 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

11 Roquette

6 Seppic

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

10 Sigachi Industries

2 The Dow Chemical Company

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives

39 Fillers, Diluents & Binders

20 Controlled & Modified Release

14 Granulation

14 Disintegrants & Superdisintegrants

13 Direct Compression

13 Thickeners and Stabilizers

12 Lubricants & Glidants

7 Film Formers & Plasticizers

7 Co-Processed Excipients

6 Taste Masking

5 Empty Capsules

4 Coloring Agents

4 Rheology Modifiers

4 Vegetarian Capsules

3 Chewable & Orodispersible Aids

3 API Stability Enhancers

2 Emulsifying Agents

1 Solubilizers

1 Topical

1 Parenteral

TABLET;ORAL - EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons