Erlotinib Hydrochloride | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Erlotinib Hydrochloride
South Africa

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

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Aurigene is a global leader in accelerating drug innovation through discovery, development & manufacturing.

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Midas Pharma provides expertise in developing and supplying APIs, finished products, and intermediates.

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

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xyz-pharma-m-2025-01-06

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Erlotinib Hydrochloride

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ACTIVE PHARMA INGREDIENTS

54 API Suppliers, 28 USDMF, 1 JDMF, 16 EU WC, 14 KDMF, 15 NDC API, 29 Listed Suppliers, $ API Reference Price

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

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

68 FDF Dossiers, 41 FDA Orange Book, 3 Europe, 11 Canada, 9 South Africa, 4 Listed Dossiers

68 FDF Dossiers
41 FDA Orange Book
3 Europe
11 Canada
9 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TABLET;ORAL - EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 2 DKSH, 3 Faran Shimi Pharmaceutical, 9 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

1 SPI Pharma
2 DKSH
3 Faran Shimi Pharmaceutical
9 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, 42 Fillers, Diluents & Binders, 21 Controlled & Modified Release, 21 Direct Compression, 15 Disintegrants & Superdisintegrants, 14 Granulation, 13 Lubricants & Glidants, 12 Thickeners and Stabilizers, 11 Co-Processed Excipients, 7 Film Formers & Plasticizers, 6 Taste Masking, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Chewable & Orodispersible Aids, 3 API Stability Enhancers, 2 Emulsifying Agents, 2 Rheology Modifiers, 1 Topical, 1 Parenteral, 1 Surfactant & Foaming Agents, 1 Solubilizers

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

DIGITAL CONTENT

12 NEWS #PharmaBuzz

12 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 3 Finished Drug Prices

1 US Medicaid Prescriptions
3 Finished Drug Prices

MARKET PLACE

3 APIs, 1 FDF Dossiers

3 APIs
1 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 Others

1 Others

$ API Ref.Price (USD/KG) : 3,396 Xls

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9 All

01 3Cipla Medpro (Pty) Ltd

02 3Eurolab (Pty) Ltd

03 3Roche Products (Pty) Ltd

filter Active Ingredients Reset all filters

9 All

01 3Erlotinib Hcl

02 6Erlotinib Hydrochloride

filter Dosage Form Reset all filters

9 All

01 3FCT

02 6TAB

filter Brand Name Reset all filters

9 All

01 1Erlocip 100

02 1Erlocip 150

03 1Erlocip 25

04 3Tarceva®

05 1Tarpib 100 mg

06 1Tarpib 150 mg

07 1Tarpib 25 mg

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01

Cipla Medpro (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Erlotinib Hydrochloride

Brand Name : Erlocip 25

Dosage Form : TAB

Dosage Strength : 25mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Cipla Medpro (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Erlotinib Hydrochloride

Brand Name : Erlocip 100

Dosage Form : TAB

Dosage Strength : 100mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

Cipla Medpro (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Erlotinib Hydrochloride

Brand Name : Erlocip 150

Dosage Form : TAB

Dosage Strength : 150mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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04

Eurolab (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Erlotinib Hydrochloride

Brand Name : Tarpib 25 mg

Dosage Form : FCT

Dosage Strength : 25mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Product Web Link

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Corporate PDF

05

Eurolab (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Erlotinib Hydrochloride

Brand Name : Tarpib 100 mg

Dosage Form : FCT

Dosage Strength : 100mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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06

Eurolab (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Erlotinib Hydrochloride

Brand Name : Tarpib 150 mg

Dosage Form : FCT

Dosage Strength : 150mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Product Web Link

Digital Content

Corporate PDF

07

Roche Products (Pty) Ltd

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Roche Products (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Erlotinib Hcl

Brand Name : Tarceva®

Dosage Form : TAB

Dosage Strength : 25mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

Roche Products (Pty) Ltd

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Roche Products (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Erlotinib Hcl

Brand Name : Tarceva®

Dosage Form : TAB

Dosage Strength : 100mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Roche Products (Pty) Ltd

PharmaVenue

Not Confirmed

Roche Products (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Erlotinib Hcl

Brand Name : Tarceva®

Dosage Form : TAB

Dosage Strength : 150mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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