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List of Drug Master Files (DMF) of Telmisartan Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

Telmisartan
Amlodipine Besylate
CAS 528560-93-2
Dibenzimidazole
CAS 152628-02-9
CAS 144702-27-2
CAS 114772-38-2
USDMF

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Telmisartan

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

132 API Suppliers, 41 USDMF, 40 CEP/COS, 19 JDMF, 37 EU WC, 43 KDMF, 20 NDC API, 73 Listed Suppliers, $ API Reference Price

132 API Suppliers
41 USDMF
40 CEP/COS
19 JDMF
37 EU WC
43 KDMF
20 NDC API
73 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

INTERMEDIATES

45 API Suppliers

45 API Suppliers

FINISHED DOSAGE FORMULATIONS

869 FDF Dossiers, 104 FDA Orange Book, 410 Europe, 64 Canada, 28 Australia, 65 South Africa, 198 Listed Dossiers

869 FDF Dossiers
104 FDA Orange Book
410 Europe
64 Canada
28 Australia
65 South Africa
198 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 20MG, TABLET;ORAL - 40MG, TABLET;ORAL - 80MG, TABLET;ORAL - 12.5MG;40MG, TABLET;ORAL - 12.5MG;80MG, TABLET;ORAL - 25MG;80MG, TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 20MG
TABLET;ORAL - 40MG
TABLET;ORAL - 80MG
TABLET;ORAL - 12.5MG;40MG
TABLET;ORAL - 12.5MG;80MG
TABLET;ORAL - 25MG;80MG
TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Rochem International Inc, 18 SPI Pharma, 2 DKSH, 2 Jai Radhe Sales, 8 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 1 Aeon Procare, 2 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 14 BASF, 10 Corel Pharma Chem, 7 DFE Pharma, 8 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 NEWEDGE Overseas, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 6 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 29 Roquette, 7 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 3 Ulanqab Kema New Material, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

92 Fillers, Diluents & Binders, 47 Direct Compression, 45 Coating Systems & Additives, 44 Disintegrants & Superdisintegrants, 26 Granulation, 24 Controlled & Modified Release, 21 Lubricants & Glidants, 20 Chewable & Orodispersible Aids, 20 Co-Processed Excipients, 19 Thickeners and Stabilizers, 18 Taste Masking, 15 Film Formers & Plasticizers, 11 Solubilizers, 9 Parenteral, 6 API Stability Enhancers, 5 Empty Capsules, 4 Emulsifying Agents, 4 Vegetarian Capsules, 3 Rheology Modifiers, 3 Coloring Agents, 1 Soft Gelatin

92 Fillers, Diluents & Binders
47 Direct Compression
45 Coating Systems & Additives
44 Disintegrants & Superdisintegrants
26 Granulation
24 Controlled & Modified Release
21 Lubricants & Glidants
20 Chewable & Orodispersible Aids
20 Co-Processed Excipients
19 Thickeners and Stabilizers
18 Taste Masking
15 Film Formers & Plasticizers
11 Solubilizers
9 Parenteral
6 API Stability Enhancers
5 Empty Capsules
4 Emulsifying Agents
4 Vegetarian Capsules
3 Rheology Modifiers
3 Coloring Agents
1 Soft Gelatin

DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 41 NEWS #PharmaBuzz

5 DATA COMPILATION #PharmaFlow
41 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 372 Finished Drug Prices, 7 Annual Reports

2 US Medicaid Prescriptions
372 Finished Drug Prices
7 Annual Reports

MARKET PLACE

31 APIs, 12 FDF Dossiers

31 APIs
12 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 Health Canada Patents

6 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 2 USP, 19 Others

3 EDQM
2 USP
19 Others

ANALYTICAL

2 BioAnalytical Methods, 2 Analytical Methods

2 BioAnalytical Methods
2 Analytical Methods

$ API Ref.Price (USD/KG) : 146 Xls

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41 All

01 1Actavis Inc

02 1Alembic Pharmaceuticals Limited

03 1Amino Chemicals

04 1Amoli Organics

05 1Aurobindo Pharma Limited

06 1COSMA S.p.A

07 1Cadila Pharmaceuticals

08 1Chromo Laboratories

09 1Cipla

10 1Divis Laboratories

11 1FDC

12 2Glenmark Life Sciences

13 1Glenmark Pharmaceuticals

14 2Glochem Industries

15 1Hetero Drugs

16 1Ind Swift Laboratories Limited

17 1Ipca Laboratories

18 1Jiangxi Synergy Pharmaceutical

19 1Jubilant Generics

20 1Lupin Ltd

21 1MSN Laboratories

22 1Macleods Pharmaceuticals Limited

23 1Mankind Pharma

24 1Micro Labs Limited

25 1RANBAXY LABORATORIES LIMITED

26 1SEQUEL PHARMACHEM PRIVATE LTD. IN 400 706 Nerul

27 1Sharon Bio-Medicine Limited

28 1Signa S.A. de C.V.

29 1TOPHARMAN SHANDONG CO LTD

30 1Teva API

31 1Torrent Pharmaceuticals Limited

32 1UQUIFA

33 1Unichem Laboratories Limited

34 1Vasudha Pharma Chem

35 1Viatris

36 1Zhejiang Apeloa Jiayuan Pharmaceutical

37 1Zhejiang Huahai Pharmaceutical

38 1Zhejiang Tianyu Pharmaceutical Co., Ltd

39 1Zydus Lifesciences

filter Subject Reset all filters

41 All

01 14TELMISARTAN

02 1TELMISARTAN API

03 1TELMISARTAN EP

04 1TELMISARTAN METHYL ESTER

05 17TELMISARTAN USP

06 1TELMISARTAN USP (D297 PROCESS)

07 1TELMISARTAN USP (NON-STERILE BULK)

08 1TELMISARTAN USP (NON-STERILE DRUG SUBSTANCE)

09 1TELMISARTAN USP [ROUTE CODE - TM]

10 1TELMISARTAN USP/EP

11 1TELMISARTAN, USP

12 1TELMISARTAN, USP (FORM A)

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41 All

01 5China

02 29India

03 1Ireland

04 1Israel

05 1Italy

06 1Malta

07 1Mexico

08 1Spain

09 1U.S.A

filter Status Reset all filters

41 All

01 25Active

02 16Inactive

filter GDUFA DMF Review Reset all filters

41 All

01 11Complete

02 30Blank

Octavius Telmisartan

API Suppliers
USDMF
CEP/COS
JDMF
EU WC
KDMF
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Teva Pharmaceutical Industries Ltd

USDMF

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Not Confirmed

01

Teva Pharmaceutical Industries Ltd

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Digital Content

Telmisartan

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 22123

Submission : 2008-11-18

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Alembic Pharmaceuticals Ltd

USDMF

Formnext Forum

Not Confirmed

02

Alembic Pharmaceuticals Ltd

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Digital Content

Telmisartan Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-01-08

Pay. Date : 2012-12-21

DMF Number : 20285

Submission : 2007-02-07

Status : Active

Type : II

Product Web Link

Digital Content

03

Amino Chemicals Ltd

USDMF

Formnext Forum

Not Confirmed

03

Amino Chemicals Ltd

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Digital Content

Telmisartan

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 20882

Submission : 2007-09-26

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Cipla Ltd

USDMF

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Not Confirmed

04

Cipla Ltd

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Digital Content

Telmisartan Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 19987

Submission : 2006-11-22

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Jubilant Pharmova Ltd

USDMF

Formnext Forum

Not Confirmed

05

Jubilant Pharmova Ltd

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Digital Content

Telmisartan

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 24052

Submission : 2010-11-04

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Msn Pharmachem Private Ltd

USDMF

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06

Msn Pharmachem Private Ltd

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Digital Content

Telmisartan Usp [route Code - Tm]

GDUFA

DMF Review : Complete

Rev. Date : 2021-01-23

Pay. Date : 2021-01-19

DMF Number : 22731

Submission : 2009-04-07

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

07

Mylan Laboratories Ltd

USDMF

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07

Mylan Laboratories Ltd

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Digital Content

Telmisartan Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 20109

Submission : 2007-01-03

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Zhejiang Apeloa Jiayuan Pharmaceutic...

USDMF

Formnext Forum

Not Confirmed

08

Zhejiang Apeloa Jiayuan Pharmaceutic...

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Digital Content

Telmisartan Api

GDUFA

DMF Review : Complete

Rev. Date : 2014-09-08

Pay. Date : 2014-03-04

DMF Number : 23829

Submission : 2010-05-10

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

09

Zhejiang Huahai Pharmaceutical Co Lt...

USDMF

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09

Zhejiang Huahai Pharmaceutical Co Lt...

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Digital Content

Telmisartan Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-10-25

Pay. Date : 2012-11-23

DMF Number : 21466

Submission : 2007-07-18

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Zydus Lifesciences Ltd

USDMF

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10

Zydus Lifesciences Ltd

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Digital Content

Telmisartan Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 22689

Submission : 2009-03-31

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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