BIBW 2992 MA2 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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BIBW 2992 MA2
FDA Orange Book

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

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FAMAR CDMO- From early development to commercial manufacturing.

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pharmacompass-1-m-2026-03-23

Zach System is committed to providing Highly Customized Solutions for all your Development Programs.

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Arlanda is your partner for the Brazil market.

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pharmacompass-2-m-2026-03-23

BIBW 2992 MA2

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

30 API Suppliers, 9 USDMF, 3 EU WC, 3 KDMF, 5 NDC API, 22 Listed Suppliers, $ API Reference Price

30 API Suppliers
9 USDMF
3 EU WC
3 KDMF
5 NDC API
22 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

81 Drugs in Development

81 Drugs in Development

INTERMEDIATES

28 Intermediate Suppliers

28 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

58 FDF Dossiers, 9 FDA Orange Book, 28 Europe, 9 Canada, 6 Australia, 3 South Africa, 3 Listed Dossiers

58 FDF Dossiers
9 FDA Orange Book
28 Europe
9 Canada
6 Australia
3 South Africa
3 Listed Dossiers

DIGITAL CONTENT

32 News #PharmaBuzz

32 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 4 Regulatory FDF Prices

1 US Medicaid Prescriptions
4 Regulatory FDF Prices

MARKET PLACE

6 APIs, 1 FDF Dossiers

6 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

30 US Patents, 15 Health Canada Patents

30 US Patents
15 Health Canada Patents

REF. STANDARDS & IMPURITIES

7 Others

7 Others

$ API Ref.Price (USD/KG) : 14,597 Xls

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9 All

01 3BOEHRINGER INGELHEIM

02 3MSN PHARMACEUTICALS INC

03 3SANDOZ INC

filter Dosage Reset all filters

9 All

01 3TABLET

02 6TABLET;ORAL

filter Regulatory Info Reset all filters

9 All

01 3RX

02 6Blank

filter Brand Name Reset all filters

9 All

01 6AFATINIB

02 3GILOTRIF

filter RLD Reset all filters

9 All

01 3Yes

02 6Blank

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BOEHRINGER INGELHEIM

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BOEHRINGER INGELHEIM

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RLD : Yes

TE Code :

AFATINIB DIMALEATE

Brand Name : GILOTRIF

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 20MG BASE

Approval Date : 2013-07-12

Application Number : 201292

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

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02

BOEHRINGER INGELHEIM

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BOEHRINGER INGELHEIM

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RLD : Yes

TE Code :

AFATINIB DIMALEATE

Brand Name : GILOTRIF

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 30MG BASE

Approval Date : 2013-07-12

Application Number : 201292

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

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03

BOEHRINGER INGELHEIM

ELCC

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BOEHRINGER INGELHEIM

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Digital Content

RLD : Yes

TE Code :

AFATINIB DIMALEATE

Brand Name : GILOTRIF

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 40MG BASE

Approval Date : 2013-07-12

Application Number : 201292

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

MSN PHARMACEUTICALS INC

ELCC

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MSN PHARMACEUTICALS INC

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RLD :

TE Code :

Brand Name : AFATINIB

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date :

Application Number : 210804

RX/OTC/DISCN :

RLD :

TE Code :

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05

MSN PHARMACEUTICALS INC

ELCC

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MSN PHARMACEUTICALS INC

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RLD :

TE Code :

Brand Name : AFATINIB

Dosage Form : TABLET;ORAL

Dosage Strength : 30MG

Approval Date :

Application Number : 210804

RX/OTC/DISCN :

RLD :

TE Code :

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06

MSN PHARMACEUTICALS INC

ELCC

Not Confirmed

MSN PHARMACEUTICALS INC

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RLD :

TE Code :

Brand Name : AFATINIB

Dosage Form : TABLET;ORAL

Dosage Strength : 40MG

Approval Date :

Application Number : 210804

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

SANDOZ INC

ELCC

Not Confirmed

SANDOZ INC

ELCC

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RLD :

TE Code :

Brand Name : AFATINIB

Dosage Form : TABLET

Dosage Strength : 30MG

Approval Date :

Application Number : 210703

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

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Corporate PDF

08

SANDOZ INC

ELCC

Not Confirmed

SANDOZ INC

ELCC

Not Confirmed

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Digital Content

RLD :

TE Code :

Brand Name : AFATINIB

Dosage Form : TABLET

Dosage Strength : 20MG

Approval Date :

Application Number : 210703

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

SANDOZ INC

ELCC

Not Confirmed

SANDOZ INC

ELCC

Not Confirmed

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Digital Content

RLD :

TE Code :

Brand Name : AFATINIB

Dosage Form : TABLET

Dosage Strength : 40MG

Approval Date :

Application Number : 210703

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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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.