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Erlotinib Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

65 API Suppliers, 28 USDMF, 2 CEP/COS, 1 JDMF, 15 EU WC, 14 KDMF, 14 NDC API, 28 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

111 FDF Dossiers, 41 FDA Orange Book, 43 Europe, 10 Canada, 11 South Africa, 6 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TABLET;ORAL - EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 5 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, 4 Ideal Cures, 1 Ingredion Pharma Solutions, 19 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 1 Neelkanth MineChem, 2 Nitika Pharmaceutical Specialities, 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, 9 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

39 Coating Systems & Additives, 30 Fillers, Diluents & Binders, 17 Granulation, 15 Controlled & Modified Release, 14 Disintegrants & Superdisintegrants, 14 Direct Compression, 12 Lubricants & Glidants, 11 Thickeners and Stabilizers, 9 Co-Processed Excipients, 6 Film Formers & Plasticizers, 6 Taste Masking, 5 Empty Capsules, 4 Chewable & Orodispersible Aids, 4 Vegetarian Capsules, 3 API Stability Enhancers, 3 Emulsifying Agents, 2 Coloring Agents, 2 Rheology Modifiers, 1 Parenteral, 1 Surfactant & Foaming Agents, 1 Solubilizers, 1 Topical

DIGITAL CONTENT

12 News #PharmaBuzz

12 News #PharmaBuzz

GLOBAL SALES INFORMATION

6 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
27/02/2026	TAPI Technology & API Services	Israel	TAPI NL BV	23183	ERLOTINIB HCL	2009-10-16	Active	II	Complete	2012-11-23	2012-11-08
27/02/2026	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

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

Erlotinib Hydrochloride

Erlotinib Hydrochloride

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

65 API Suppliers

28 USDMF

2 CEP/COS

1 JDMF

15 EU WC

14 KDMF

14 NDC API

28 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

111 FDF Dossiers

41 FDA Orange Book

43 Europe

10 Canada

11 South Africa

6 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

5 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

4 Ideal Cures

1 Ingredion Pharma Solutions

19 Kerry

2 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

10 Microlex e.U

1 Neelkanth MineChem

2 Nitika Pharmaceutical Specialities

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

9 Sigachi Industries

3 Silverline Chemicals

2 The Dow Chemical Company

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

39 Coating Systems & Additives

30 Fillers, Diluents & Binders

17 Granulation

15 Controlled & Modified Release

14 Disintegrants & Superdisintegrants

14 Direct Compression

12 Lubricants & Glidants

11 Thickeners and Stabilizers

9 Co-Processed Excipients

6 Film Formers & Plasticizers

6 Taste Masking

5 Empty Capsules

4 Chewable & Orodispersible Aids

4 Vegetarian Capsules

3 API Stability Enhancers

3 Emulsifying Agents

2 Coloring Agents

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