Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
01 3Bal Pharma
02 6Dr. 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 2Alhavi Pharma
10 3Alkem Laboratories
11 5Anwita Drugs
12 6Apotex Inc
13 6Arrotex Pharmaceuticals
14 3Ascent Innovative Medicines
15 54Boehringer Ingelheim GmbH
16 3CHEMO
17 3DOC Generici
18 3Dr Reddy's Laboratories (Pty) Ltd
19 3EG Spa
20 3Farm Agon
21 3Glenmark Pharmaceuticals
22 6Hetero Drugs
23 3Laboratorio Eczane Pharma
24 1Lee Pharma
25 1Loxim Industries
26 3MSN Laboratories
27 1Murli Krishna Pharma
28 1ORIFARM GROUP AS
29 3Orchid Pharma
30 2Pantson Pharma Pvt. Limited
31 5Pharmacore Inc
32 3Precise Group
33 12Sandoz B2B
34 4Spirig Healthcare
35 3Teva Pharmaceutical Industries
36 3Titan Laboratories
37 2Unichem Laboratories Limited
38 2Viatris
01 8CAP
02 9CAPSULE
03 33CAPSULE;ORAL
04 9Caps
05 23Capsule
06 3Capsule - Pellet
07 15Capsule, hard
08 3Capsules
09 1Dabigatran 110Mg 10 Units Oral Use
10 1Dabigatran 110Mg 30 Joined' Oral Use
11 1Dabigatran 110Mg 60 Units Oral Use
12 1Dabigatran 150Mg 60 Units Oral Use
13 1Dabigatran 75Mg 10 Units Oral Use
14 1Dabigatran 75Mg 30 Joined' Oral Use
15 3HARD CAPSULES
16 6Hard Capsule
17 6Hard Capsules
18 3Kaps
19 3Kapsel, hard
20 3Oral Solid Dosage Form
21 2PELLET
22 6PELLETS;ORAL
23 1Pellets For Capsule
24 1Pellets for Capsules
25 1Pellets for capsules
26 1Sustain Release Pellet
27 5Tablet
28 22capsule
29 5Blank
01 12Generic
02 3Generic EU CTD
03 3Lead Market Dossiers- Filed
04 5Originator
05 6Prescription
06 32RX
07 116Blank
01 3APO-DABIGATRAN
02 6ARX-Dabigatran
03 1DABIGATRAN 110 DRL
04 1DABIGATRAN 150 DRL
05 1DABIGATRAN 75 DRL
06 30DABIGATRAN ETEXILATE MESYLATE
07 3DABIGATRAN ETEXYLATED DOC
08 3DABIGATRAN ETEXYLATED EG STADA
09 1Dabexa
10 1Dabexa
11 3Dabidane
12 4Dabigatran
13 9Dabigatran Sandoz
14 4Dabigatran Spirig HC
15 3Dabigatran etexilate Sandoz
16 1Dabitrin 110mg
17 1Dabitrin 150mg
18 1Dabitrin 75 mg
19 5PHARMACOR DABIGATRAN
20 15PRADAXA
21 38Pradaxa
22 2Pradaxa 110 mg
23 1Pradaxa 150 mg
24 2Pradaxa 75 mg
25 38Blank
01 3Argentina
02 26Australia
03 6Canada
04 3Greece
05 35India
06 2Iran
07 15Italy
08 18Norway
09 1Poland
10 11South Africa
11 3Spain
12 3Sweden
13 12Switzerland
14 39USA
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 : RX
Registration Country : USA
Brand Name : DABIGATRAN ETEXILATE MESYLATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 75MG BASE
Packaging :
Approval Date : 2025-01-28
Application Number : 208048
Regulatory Info : RX
Registration Country : USA
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 : Dabigatran
Dosage Form : Pellets for Capsules
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 : RX
Registration Country : USA
Brand Name : DABIGATRAN ETEXILATE MESYLATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 110MG BASE
Packaging :
Approval Date : 2025-01-28
Application Number : 208048
Regulatory Info : RX
Registration Country : USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
Brand Name : DABIGATRAN ETEXILATE MESYLATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 150MG BASE
Packaging :
Approval Date : 2025-01-28
Application Number : 208048
Regulatory Info : RX
Registration Country : USA
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
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 : 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 : 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
