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

Client Email

Product

Tizanidine
DTXCID406701
4-Methylbenzenesulfonic Acid
4-Amino-5-Chloro-2,1,3-Benzothiadiazole
USDMF

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Tizanidine

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

30 API Suppliers, 13 USDMF, 2 CEP/COS, 6 JDMF, 7 EU WC, 3 KDMF, 7 NDC API, 15 Listed Suppliers, $ API Reference Price

30 API Suppliers
13 USDMF
2 CEP/COS
6 JDMF
7 EU WC
3 KDMF
7 NDC API
15 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Exports

FINISHED DOSAGE FORMULATIONS

113 FDF Dossiers, 74 FDA Orange Book, 13 Europe, 2 Canada, 24 Listed Dossiers

113 FDF Dossiers
74 FDA Orange Book
13 Europe
2 Canada
24 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 4MG BASE, CAPSULE;ORAL - EQ 2MG BASE, CAPSULE;ORAL - EQ 4MG BASE, CAPSULE;ORAL - EQ 6MG BASE

TABLET;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 4MG BASE
CAPSULE;ORAL - EQ 2MG BASE
CAPSULE;ORAL - EQ 4MG BASE
CAPSULE;ORAL - EQ 6MG BASE

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 8 DKSH, 1 Jai Radhe Sales, 11 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 1 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 10 BASF, 10 Corel Pharma Chem, 6 DFE Pharma, 3 Doshion Polyscience, 1 Finar, 6 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 18 Roquette, 8 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

61 Fillers, Diluents & Binders, 49 Coating Systems & Additives, 31 Direct Compression, 22 Controlled & Modified Release, 20 Granulation, 20 Thickeners and Stabilizers, 19 Disintegrants & Superdisintegrants, 15 Co-Processed Excipients, 13 Taste Masking, 11 Film Formers & Plasticizers, 10 Lubricants & Glidants, 9 Empty Capsules, 6 Chewable & Orodispersible Aids, 5 Coloring Agents, 5 Topical, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Emulsifying Agents, 3 Parenteral, 3 Solubilizers, 3 Rheology Modifiers, 1 Surfactant & Foaming Agents

61 Fillers, Diluents & Binders
49 Coating Systems & Additives
31 Direct Compression
22 Controlled & Modified Release
20 Granulation
20 Thickeners and Stabilizers
19 Disintegrants & Superdisintegrants
15 Co-Processed Excipients
13 Taste Masking
11 Film Formers & Plasticizers
10 Lubricants & Glidants
9 Empty Capsules
6 Chewable & Orodispersible Aids
5 Coloring Agents
5 Topical
4 Vegetarian Capsules
4 API Stability Enhancers
4 Emulsifying Agents
3 Parenteral
3 Solubilizers
3 Rheology Modifiers
1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 24 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
24 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 19 Finished Drug Prices

2 US Medicaid Prescriptions
19 Finished Drug Prices

MARKET PLACE

9 APIs, 2 FDF Dossiers

9 APIs
2 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 USP, 5 Others

3 USP
5 Others

$ API Ref.Price (USD/KG) : 700 Xls

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13 All

01 1FARMAK, a.s

02 1Dr. Reddy\'s Laboratories

03 1Actavis Inc

04 1Apotex Pharmachem

05 1Corden Pharma Bergamo S.p.A

06 1Hetero Drugs

07 1Par Pharmaceutical

08 1Sandoz B2B

09 1Sun Pharmaceutical Industries Limited

10 1Symed Labs

11 1Unichem Laboratories Limited

12 1Viatris

13 1Zydus Lifesciences

filter Subject Reset all filters

13 All

01 1TIZANIDINE HCL

02 1TIZANIDINE HCL USP

03 3TIZANIDINE HYDROCHLORIDE

04 7TIZANIDINE HYDROCHLORIDE USP

05 1TIZANIDINE HYDROCHLORIDE, USP

filter Country Reset all filters

13 All

01 1Canada

02 1Czech Republic

03 6India

04 1Ireland

05 1Italy

06 1Switzerland

07 2U.S.A

filter Status Reset all filters

13 All

01 9Active

02 4Inactive

filter GDUFA DMF Review Reset all filters

13 All

01 6Complete

02 7Blank

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

List of Suppliers

Product Main Page

01

Farmak As

CPhI Worldwide, Milan

Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

Contact Supplier

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Digital Content

Tizanidine Hcl

GDUFA

DMF Review : Complete

Rev. Date : 2015-03-03

Pay. Date : 2014-10-14

DMF Number : 15525

Submission : 2001-07-04

Status : Active

Type : II

Farmak Company Banner

Product Web Link

Digital Content

02

Dr Reddys Laboratories Ltd

CPhI Worldwide, Milan

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

Contact Supplier

Digital Content

Tizanidine Hydrochloride Usp

GDUFA

DMF Review : Complete

Rev. Date : 2014-01-23

Pay. Date : 2013-04-12

DMF Number : 15699

Submission : 2001-11-02

Status : Active

Type : II

Dr Reddy Company Banner

Product Web Link

Digital Content

03

Teva Pharmaceutical Industries Ltd

USDMF

Formnext Forum

Not Confirmed

03

Teva Pharmaceutical Industries Ltd

Formnext Forum

Not Confirmed

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Digital Content

Tizanidine Hydrochloride Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 15820

Submission : 2002-01-22

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Endo Operations Ltd

USDMF

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Not Confirmed

04

Endo Operations Ltd

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Not Confirmed

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Digital Content

Tizanidine Hydrochloride, Usp

GDUFA

DMF Review : Complete

Rev. Date : 2014-07-07

Pay. Date : 2014-04-10

DMF Number : 28176

Submission : 2014-04-18

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Sandoz Pharma Ltd

USDMF

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Not Confirmed

05

Sandoz Pharma Ltd

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Digital Content

Tizanidine Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 9242

Submission : 1991-07-16

Status : Inactive

Type : II

Product Web Link

Digital Content

06

Sun Pharmaceutical Industries Ltd

USDMF

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Not Confirmed

06

Sun Pharmaceutical Industries Ltd

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Digital Content

Tizanidine Hydrochloride Usp

GDUFA

DMF Review : Complete

Rev. Date : 2018-08-14

Pay. Date : 2018-07-17

DMF Number : 15727

Submission : 2001-10-31

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Symed Labs Ltd

USDMF

Formnext Forum

Not Confirmed

07

Symed Labs Ltd

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Not Confirmed

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Digital Content

Tizanidine Hydrochloride Usp

GDUFA

DMF Review : Complete

Rev. Date : 2022-02-09

Pay. Date : 2022-01-27

DMF Number : 33900

Submission : 2019-07-09

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

08

Unichem Laboratories Ltd

USDMF

Formnext Forum

Not Confirmed

08

Unichem Laboratories Ltd

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Digital Content

Tizanidine Hcl Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 15739

Submission : 2001-11-12

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Tianish Laboratories Private Ltd

USDMF

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Not Confirmed

09

Tianish Laboratories Private Ltd

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Digital Content

Tizanidine Hydrochloride Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 22354

Submission : 2008-12-17

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Zydus Lifesciences Ltd

USDMF

Formnext Forum

Not Confirmed

10

Zydus Lifesciences Ltd

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Digital Content

Tizanidine Hydrochloride Usp

GDUFA

DMF Review : Complete

Rev. Date : 2020-11-12

Pay. Date : 2020-09-30

DMF Number : 34929

Submission : 2020-06-23

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
2

Tizanidine Manufacturers | Traders | Suppliers

Tizanidine Manufacturers, Traders, Suppliers 1

42

We have 13 companies offering Tizanidine

Get in contact with the supplier of your choice:

FARMAK, a.s
Dr. Reddy\'s Laboratories
Actavis Inc
Apotex Pharmachem
Corden Pharma Bergamo S.p.A
Hetero Drugs
Par Pharmaceutical
Sandoz B2B
Sun Pharmaceutical Industries Limited
Symed Labs
Unichem Laboratories Limited
Viatris
Zydus Lifesciences

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