Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
01 3Bal Pharma
02 3Dr. Reddy's Laboratories
03 4Cohance Lifesciences
04 3Breckenridge Pharmaceutical
05 1Octavius Pharma Pvt. Ltd
06 3Pharmathen SA
07 1Adamed Pharma
08 4Alembic Pharmaceuticals Limited
09 3Alkem Laboratories
10 3Anwita Drugs & Chemicals Pvt Ltd
11 6Apotex Inc
12 6Arrotex Pharmaceuticals
13 3Ascent Innovative Medicines
14 54Boehringer Ingelheim GmbH
15 3CHEMO
16 3DOC Generici
17 3EG Spa
18 3Farm Agon
19 3Glenmark Pharmaceuticals
20 3Hetero Drugs
21 3Laboratorio Eczane Pharma
22 1Lee Pharma
23 3MSN Laboratories
24 1Murli Krishna Pharma
25 1ORIFARM GROUP AS
26 3Orchid Pharma
27 2Pantson Pharma Pvt. Limited
28 5Pharmacore Inc
29 3Precise Group
30 12Sandoz B2B
31 4Spirig Healthcare
32 3Teva Pharmaceutical Industries
33 3Titan Laboratories
34 2Unichem Laboratories Limited
35 1Viatris
36 3XYZ Pharma
01 5CAP
02 9CAPSULE
03 32CAPSULE;ORAL
04 9Caps
05 23Capsule
06 3Capsule - Pellet
07 15Capsule, hard
08 1Dabigatran 110Mg 10 Units Oral Use
09 1Dabigatran 110Mg 30 Joined' Oral Use
10 1Dabigatran 110Mg 60 Units Oral Use
11 1Dabigatran 150Mg 60 Units Oral Use
12 1Dabigatran 75Mg 10 Units Oral Use
13 1Dabigatran 75Mg 30 Joined' Oral Use
14 3HARD CAPSULES
15 6Hard Capsule
16 6Hard Capsules
17 3Kaps
18 3Kapsel, hard
19 3Oral Solid Dosage Form
20 6PELLETS;ORAL
21 1Pellets For Capsule
22 1Pellets for Capsule
23 1Sustain Release Pellet
24 3Tablet
25 22capsule
26 5Blank
01 6Generic
02 3Generic EU CTD
03 3Lead Market Dossiers- Filed
04 5Originator
05 27RX
06 121Blank
01 3APO-DABIGATRAN
02 6ARX-Dabigatran
03 29DABIGATRAN ETEXILATE MESYLATE
04 3DABIGATRAN ETEXYLATED DOC
05 3DABIGATRAN ETEXYLATED EG STADA
06 3Dabidane
07 3Dabigatran
08 9Dabigatran Sandoz
09 4Dabigatran Spirig HC
10 3Dabigatran etexilate Sandoz
11 5PHARMACOR DABIGATRAN
12 15PRADAXA
13 38Pradaxa
14 2Pradaxa 110 mg
15 1Pradaxa 150 mg
16 2Pradaxa 75 mg
17 36Blank
01 3Argentina
02 26Australia
03 6Canada
04 3Greece
05 32India
06 15Italy
07 18Norway
08 1Poland
09 5South Africa
10 3Spain
11 3Sweden
12 12Switzerland
13 38USA
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Regulatory Info :
Registration Country : India
Brand Name : Dabigatran
Dosage Form : Capsule
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : DABIGATRAN ETEXILATE MESYLATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 75MG BASE
Packaging :
Approval Date : 2024-12-19
Application Number : 207922
Regulatory Info : RX
Registration Country : USA
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Pellets for Capsule
Dosage Strength : 35%, 40%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info :
Registration Country : Greece
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Greece
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Regulatory Info :
Registration Country : India
Brand Name : Dabigatran
Dosage Form : Capsule
Dosage Strength : 110MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Regulatory Info :
Registration Country : India
Brand Name : Dabigatran
Dosage Form : Capsule
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 110MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 110MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Sustain Release Pellet
Dosage Strength : 35%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : DABIGATRAN ETEXILATE MESYLATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 150MG BASE
Packaging :
Approval Date : 2024-12-19
Application Number : 207922
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DABIGATRAN ETEXILATE MESYLATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 110MG BASE
Packaging :
Approval Date : 2024-12-19
Application Number : 207922
Regulatory Info : RX
Registration Country : USA
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info :
Registration Country : Greece
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 110MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info :
Registration Country : Greece
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Greece
Regulatory Info :
Registration Country : USA
Brand Name : DABIGATRAN ETEXILATE MESYLATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 150MG BASE
Packaging :
Approval Date :
Application Number : 208046
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DABIGATRAN ETEXILATE MESYLATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 75MG BASE
Packaging :
Approval Date : 2020-03-11
Application Number : 208040
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DABIGATRAN ETEXILATE MESYLATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 150MG BASE
Packaging :
Approval Date : 2020-03-11
Application Number : 208040
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DABIGATRAN ETEXILATE MESYLATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 110MG BASE
Packaging :
Approval Date : 2024-09-11
Application Number : 208040
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : PRADAXA
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 75MG BASE
Packaging :
Approval Date : 2010-10-19
Application Number : 22512
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : PRADAXA
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 150MG BASE
Packaging :
Approval Date : 2010-10-19
Application Number : 22512
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : PRADAXA
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 110MG BASE
Packaging :
Approval Date : 2015-11-20
Application Number : 22512
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : DABIGATRAN ETEXILATE MESYLATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 75MG BASE
Packaging :
Approval Date :
Application Number : 207984
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : DABIGATRAN ETEXILATE MESYLATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 110MG BASE
Packaging :
Approval Date :
Application Number : 207984
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : DABIGATRAN ETEXILATE MESYLATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 150MG BASE
Packaging :
Approval Date :
Application Number : 207984
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DABIGATRAN ETEXILATE MESYLATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 75MG BASE
Packaging :
Approval Date : 2020-05-06
Application Number : 207961
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DABIGATRAN ETEXILATE MESYLATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 150MG BASE
Packaging :
Approval Date : 2020-05-06
Application Number : 207961
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DABIGATRAN ETEXILATE MESYLATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 110MG BASE
Packaging :
Approval Date : 2024-08-13
Application Number : 207961
Regulatory Info : RX
Registration Country : USA
