FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

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Erlotinib Hydrochloride

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ACTIVE PHARMA INGREDIENTS

67 API Suppliers, 28 USDMF, 2 CEP/COS, 1 JDMF, 15 EU WC, 15 KDMF, 14 NDC API, 29 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TABLET;ORAL - EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 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, 4 Ideal Cures, 1 Ingredion Pharma Solutions, 19 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 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, 10 Thickeners and Stabilizers, 8 Co-Processed Excipients, 6 Taste Masking, 6 Film Formers & Plasticizers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Chewable & Orodispersible Aids, 3 API Stability Enhancers, 2 Coloring Agents, 2 Emulsifying Agents, 2 Rheology Modifiers, 1 Surfactant & Foaming Agents, 1 Solubilizers, 1 Topical, 1 Parenteral

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	Certificate Holder	Certificate No.	Substance	Issue Date	Status	Type	End Date	Substance No.
29/01/2026	Hetero Drugs	India	HETERO LABS LIMITED Hyderabad IN	CEP 2024-455 - Rev 00	Erlotinib hydrochloride, Form-A	2025-11-24	Valid	Chemical		3094
29/01/2026	MSN Laboratories	India	MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN	CEP 2025-362 - Rev 00	Erlotinib hydrochloride, Crystalline form-A, micronised and non-micronised	2025-11-24	Valid	Chemical		3094

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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

67 API Suppliers

28 USDMF

2 CEP/COS

1 JDMF

15 EU WC

15 KDMF

14 NDC API

29 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

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

4 Ideal Cures

1 Ingredion Pharma Solutions

19 Kerry

2 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

10 Microlex e.U

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

10 Thickeners and Stabilizers

8 Co-Processed Excipients

6 Taste Masking

6 Film Formers & Plasticizers

5 Empty Capsules

4 Vegetarian Capsules

4 Chewable & Orodispersible Aids

3 API Stability Enhancers

2 Coloring Agents

2 Emulsifying Agents

2 Rheology Modifiers

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