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Dabigatran
FDA Orange Book

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Dabigatran

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

95 API Suppliers, 37 USDMF, 20 EU WC, 18 KDMF, 22 NDC API, 74 Listed Suppliers, $ API Reference Price

95 API Suppliers
37 USDMF
20 EU WC
18 KDMF
22 NDC API
74 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

INTERMEDIATES

121 Intermediates Suppliers

121 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

162 FDF Dossiers, 37 FDA Orange Book, 49 Europe, 6 Canada, 26 Australia, 5 South Africa, 39 Listed Dossiers

162 FDF Dossiers
37 FDA Orange Book
49 Europe
6 Canada
26 Australia
5 South Africa
39 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - EQ 110MG BASE, CAPSULE;ORAL - EQ 150MG BASE, CAPSULE;ORAL - EQ 75MG BASE

CAPSULE;ORAL - EQ 110MG BASE
CAPSULE;ORAL - EQ 150MG BASE
CAPSULE;ORAL - EQ 75MG BASE

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 2 SPI Pharma, 6 DKSH, 1 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 1 Aeon Procare, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 10 Corel Pharma Chem, 2 Finar, 3 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 12 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 2 Microlex e.U, 1 Novo Excipients, 1 Pluviaendo, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 3 Roquette, 7 Seppic, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem

2 Rochem International Inc
2 SPI Pharma
6 DKSH
1 Gangwal Healthcare
1 Nanjing Well Pharmaceutical
1 ACG Worldwide
1 Aeon Procare
1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
1 BASF
10 Corel Pharma Chem
2 Finar
3 Gangwal Chemicals
4 Ideal Cures Pvt Ltd
12 Kerry
3 Kima Chemical
6 Lonza Capsugel
2 Microlex e.U
1 Novo Excipients
1 Pluviaendo
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
3 Roquette
7 Seppic
1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Sigachi Industries
2 The Dow Chemical Company
1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

43 Coating Systems & Additives, 19 Controlled & Modified Release, 9 Film Formers & Plasticizers, 6 Thickeners and Stabilizers, 5 Empty Capsules, 5 Coloring Agents, 4 API Stability Enhancers, 4 Solubilizers, 4 Emulsifying Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 4 Fillers, Diluents & Binders, 3 Direct Compression, 3 Topical, 3 Parenteral, 2 Granulation, 2 Taste Masking, 2 Lubricants & Glidants, 1 Chewable & Orodispersible Aids, 1 Co-Processed Excipients, 1 Soft Gelatin, 1 Disintegrants & Superdisintegrants

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

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 77 NEWS #PharmaBuzz

4 DATA COMPILATION #PharmaFlow
77 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 48 Finished Drug Prices, 8 Annual Reports

2 US Medicaid Prescriptions
48 Finished Drug Prices
8 Annual Reports

MARKET PLACE

16 APIs, 4 FDF Dossiers

16 APIs
4 FDF Dossiers

PATENTS & EXCLUSIVITIES

24 US Patents, 18 US Exclusivities

24 US Patents
18 US Exclusivities

REF. STANDARDS & IMPURITIES

8 Others

8 Others

$ API Ref.Price (USD/KG) : 791 Xls

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37 All

01 2BRECKENRIDGE PHARMS

02 3ALEMBIC

03 1ALEMBIC PHARMS LTD

04 3ALKEM LABS LTD

05 3APOTEX

06 9BOEHRINGER INGELHEIM

07 3DR REDDYS LABS LTD

08 3GLENMARK PHARMS LTD

09 3HETERO LABS LTD III

10 3MSN

11 1MYLAN PHARMS INC

12 3TEVA PHARMS USA

filter Dosage Reset all filters

37 All

01 31CAPSULE;ORAL

02 6PELLETS;ORAL

filter Regulatory Info Reset all filters

37 All

01 24RX

02 13Blank

filter Brand Name Reset all filters

37 All

01 28DABIGATRAN ETEXILATE MESYLATE

02 9PRADAXA

filter RLD Reset all filters

37 All

01 15No

02 9Yes

03 13Blank

Balpharma Dabigatran Etexilate Mesylate

List of Suppliers

Product Main Page

01

BRECKENRIDGE PHARMS

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RLD :

TE Code :

DABIGATRAN ETEXILATE MESYLATE

Brand Name : DABIGATRAN ETEXILATE MESYLATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 110MG

Approval Date :

Application Number : 207922

RX/OTC/DISCN :

RLD :

TE Code :

Breckenridge Pharmaceutical

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RLD :

TE Code :

DABIGATRAN ETEXILATE MESYLATE

Brand Name : DABIGATRAN ETEXILATE MESYLATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG

Approval Date :

Application Number : 207922

RX/OTC/DISCN :

RLD :

TE Code :

Breckenridge Pharmaceutical

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03

BOEHRINGER INGELHEIM

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RLD : Yes

TE Code : AB

DABIGATRAN ETEXILATE MESYLATE

Brand Name : PRADAXA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 75MG BASE

Approval Date : 2010-10-19

Application Number : 22512

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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Digital Content

RLD : Yes

TE Code : AB

DABIGATRAN ETEXILATE MESYLATE

Brand Name : PRADAXA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2010-10-19

Application Number : 22512

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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BOEHRINGER INGELHEIM

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RLD : Yes

TE Code : AB

DABIGATRAN ETEXILATE MESYLATE

Brand Name : PRADAXA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 110MG BASE

Approval Date : 2015-11-20

Application Number : 22512

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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GLENMARK PHARMS LTD

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RLD :

TE Code :

DABIGATRAN ETEXILATE MESYLATE

Brand Name : DABIGATRAN ETEXILATE MESYLATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 75MG BASE

Approval Date :

Application Number : 207984

RX/OTC/DISCN :

RLD :

TE Code :

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GLENMARK PHARMS LTD

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RLD :

TE Code :

DABIGATRAN ETEXILATE MESYLATE

Brand Name : DABIGATRAN ETEXILATE MESYLATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 110MG BASE

Approval Date :

Application Number : 207984

RX/OTC/DISCN :

RLD :

TE Code :

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HETERO LABS LTD III

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RLD : No

TE Code : AB

DABIGATRAN ETEXILATE MESYLATE

Brand Name : DABIGATRAN ETEXILATE MESYLATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 75MG BASE

Approval Date : 2020-05-06

Application Number : 207961

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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HETERO LABS LTD III

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HETERO LABS LTD III

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Digital Content

RLD : No

TE Code : AB

DABIGATRAN ETEXILATE MESYLATE

Brand Name : DABIGATRAN ETEXILATE MESYLATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2020-05-06

Application Number : 207961

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

HETERO LABS LTD III

PackExpo

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HETERO LABS LTD III

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Digital Content

RLD : No

TE Code : AB

DABIGATRAN ETEXILATE MESYLATE

Brand Name : DABIGATRAN ETEXILATE MESYLATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 110MG BASE

Approval Date : 2024-08-13

Application Number : 207961

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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