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

Client Email

Product

Topiramate
CAS 20880-92-6
CAS 106881-35-0
D-(-)-Fructose
Phentermine
USDMF

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Bora Pharmaceuticals- Making success more certain.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Topiramate

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

51 API Suppliers, 25 USDMF, 4 CEP/COS, 6 JDMF, 16 EU WC, 34 KDMF, 27 NDC API, 23 Listed Suppliers, $ API Reference Price

51 API Suppliers
25 USDMF
4 CEP/COS
6 JDMF
16 EU WC
34 KDMF
27 NDC API
23 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 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

3 API Suppliers

3 API Suppliers

FINISHED DOSAGE FORMULATIONS

666 FDF Dossiers, 178 FDA Orange Book, 274 Europe, 55 Canada, 46 Australia, 43 South Africa, 70 Listed Dossiers

666 FDF Dossiers
178 FDA Orange Book
274 Europe
55 Canada
46 Australia
43 South Africa
70 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG, TABLET;ORAL - 200MG, TABLET;ORAL - 25MG, TABLET;ORAL - 50MG, CAPSULE, EXTENDED RELEASE;ORAL - 100MG, CAPSULE, EXTENDED RELEASE;ORAL - 150MG, CAPSULE, EXTENDED RELEASE;ORAL - 200MG, CAPSULE, EXTENDED RELEASE;ORAL - 25MG, CAPSULE, EXTENDED RELEASE;ORAL - 50MG

TABLET;ORAL - 100MG
TABLET;ORAL - 200MG
TABLET;ORAL - 25MG
TABLET;ORAL - 50MG
CAPSULE, EXTENDED RELEASE;ORAL - 100MG
CAPSULE, EXTENDED RELEASE;ORAL - 150MG
CAPSULE, EXTENDED RELEASE;ORAL - 200MG
CAPSULE, EXTENDED RELEASE;ORAL - 25MG
CAPSULE, EXTENDED RELEASE;ORAL - 50MG

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 16 SPI Pharma, 2 Seqens, 11 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 4 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 11 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 28 BASF, 2 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 12 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 20 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

95 Fillers, Diluents & Binders, 57 Coating Systems & Additives, 43 Direct Compression, 35 Controlled & Modified Release, 34 Thickeners and Stabilizers, 31 Disintegrants & Superdisintegrants, 30 Solubilizers, 29 Granulation, 27 Topical, 25 Parenteral, 23 Film Formers & Plasticizers, 23 Taste Masking, 21 Co-Processed Excipients, 20 Lubricants & Glidants, 15 Chewable & Orodispersible Aids, 13 Emulsifying Agents, 9 Empty Capsules, 9 API Stability Enhancers, 7 Surfactant & Foaming Agents, 7 Rheology Modifiers, 5 Coloring Agents, 4 Vegetarian Capsules

95 Fillers, Diluents & Binders
57 Coating Systems & Additives
43 Direct Compression
35 Controlled & Modified Release
34 Thickeners and Stabilizers
31 Disintegrants & Superdisintegrants
30 Solubilizers
29 Granulation
27 Topical
25 Parenteral
23 Film Formers & Plasticizers
23 Taste Masking
21 Co-Processed Excipients
20 Lubricants & Glidants
15 Chewable & Orodispersible Aids
13 Emulsifying Agents
9 Empty Capsules
9 API Stability Enhancers
7 Surfactant & Foaming Agents
7 Rheology Modifiers
5 Coloring Agents
4 Vegetarian Capsules

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 61 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
61 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

5 US Medicaid Prescriptions, 247 Finished Drug Prices, 1 Annual Reports

5 US Medicaid Prescriptions
247 Finished Drug Prices
1 Annual Reports

MARKET PLACE

18 APIs, 3 FDF Dossiers

18 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

137 US Patents, 4 US Exclusivities, 12 Health Canada Patents

137 US Patents
4 US Exclusivities
12 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 3 Others

2 USP
3 Others

$ API Ref.Price (USD/KG) : 174 Xls

Filters

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25 All

01 1Polpharma

02 2Alembic Pharmaceuticals Limited

03 1Alkaloida Chemical Company Zrt

04 1Aurobindo Pharma Limited

05 1Cilag AG

06 1Cipla

07 2Dishman Carbogen Amcis

08 1Divis Laboratories

09 1Glenmark Life Sciences

10 1Global Calcium

11 1Hetero Drugs

12 1Johnson & Johnson Innovative Medicine

13 1Lupin Ltd

14 1MSN Laboratories

15 1ScinoPharm Taiwan, Ltd

16 1Signa S.A. de C.V.

17 1Sun Pharmaceutical Industries Limited

18 1Torrent Pharmaceuticals Limited

19 1Unichem Laboratories Limited

20 2Unimark Remedies Limited

21 1Zhejiang Huahai Pharmaceutical

22 1Zydus Lifesciences

filter Subject Reset all filters

25 All

01 8TOPIRAMATE

02 1TOPIRAMATE DRUG SUBSTANCE

03 13TOPIRAMATE USP

04 1TOPIRAMATE USP (PROCESS A)

05 1TOPIRAMATE USP [ROUTE CODE - "TI"]

06 1Topiramate

filter Country Reset all filters

25 All

01 1China

02 1Hungary

03 18India

04 1Mexico

05 1Poland

06 1Switzerland

07 1Taiwan

08 1U.S.A

filter Status Reset all filters

25 All

01 17Active

02 8Inactive

filter GDUFA DMF Review Reset all filters

25 All

01 11Complete

02 14Blank

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

List of Suppliers

Product Main Page

01

Zaklady Farmaceutyczne Polpharma Sa

CPhI Worldwide, Milan

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

Contact Supplier

Contact Supplier

Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2015-04-03

Pay. Date : 2013-05-21

DMF Number : 20581

Submission : 2007-06-06

Status : Active

Type : II

Product Web Link

Digital Content

02

Apitoria Pharma Private Ltd

USDMF

FNCE 2024

Not Confirmed

02

Apitoria Pharma Private Ltd

FNCE 2024

Not Confirmed

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Digital Content

Topiramate Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-09-10

Pay. Date : 2013-08-29

DMF Number : 19247

Submission : 2006-03-04

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

03

Cipla Ltd

USDMF

FNCE 2024

Not Confirmed

03

Cipla Ltd

FNCE 2024

Not Confirmed

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Digital Content

Topiramate Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 15693

Submission : 2001-10-31

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Glenmark Life Sciences Ltd

USDMF

FNCE 2024

Not Confirmed

04

Glenmark Life Sciences Ltd

FNCE 2024

Not Confirmed

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Digital Content

Topiramate Usp

GDUFA

DMF Review : Complete

Rev. Date : 2016-11-10

Pay. Date : 2016-09-22

DMF Number : 17729

Submission : 2004-10-06

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Hetero Drugs Ltd

USDMF

FNCE 2024

Not Confirmed

05

Hetero Drugs Ltd

FNCE 2024

Not Confirmed

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2013-09-04

Pay. Date : 2013-08-26

DMF Number : 18346

Submission : 2005-05-12

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Janssen Pharmaceutica Nv

USDMF

FNCE 2024

Not Confirmed

06

Janssen Pharmaceutica Nv

FNCE 2024

Not Confirmed

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Digital Content

Topiramate Drug Substance

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 10919

Submission : 1994-05-27

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Scinopharm Taiwan Ltd

USDMF

FNCE 2024

Not Confirmed

07

Scinopharm Taiwan Ltd

FNCE 2024

Not Confirmed

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Digital Content

Topiramate Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17035

Submission : 2003-12-16

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

08

Sun Pharmaceutical Industries Ltd

USDMF

FNCE 2024

Not Confirmed

08

Sun Pharmaceutical Industries Ltd

FNCE 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Topiramate Usp

GDUFA

DMF Review : Complete

Rev. Date : 2023-09-25

Pay. Date : 2023-09-20

DMF Number : 18172

Submission : 2005-03-04

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Torrent Pharmaceuticals Ltd

USDMF

FNCE 2024

Not Confirmed

09

Torrent Pharmaceuticals Ltd

FNCE 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 20386

Submission : 2007-03-28

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Zydus Lifesciences Ltd

USDMF

FNCE 2024

Not Confirmed

10

Zydus Lifesciences Ltd

FNCE 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Topiramate Usp

GDUFA

DMF Review : Complete

Rev. Date : 2014-01-14

Pay. Date : 2013-12-06

DMF Number : 18700

Submission : 2005-08-25

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
2
3

Topiramate Manufacturers | Traders | Suppliers

Topiramate Manufacturers, Traders, Suppliers 1

80

We have 22 companies offering Topiramate

Get in contact with the supplier of your choice:

Polpharma
Alembic Pharmaceuticals Limited
Alkaloida Chemical Company Zrt
Aurobindo Pharma Limited
Cilag AG
Cipla
Dishman Carbogen Amcis
Divis Laboratories
Glenmark Life Sciences
Global Calcium
Hetero Drugs
Johnson & Johnson Innovative Medicine
Lupin Ltd
MSN Laboratories
ScinoPharm Taiwan, Ltd
Signa S.A. de C.V.
Sun Pharmaceutical Industries Limited
Torrent Pharmaceuticals Limited
Unichem Laboratories Limited
Unimark Remedies Limited
Zhejiang Huahai Pharmaceutical
Zydus Lifesciences

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