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List of Drug Master Files (DMF) of Tox21_300395 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

Tox21_300395
USDMF

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

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2024-09-09

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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xyz-pharma-m-2024-09-09

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Tox21_300395

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

33 API Suppliers, 10 USDMF, 12 CEP/COS, 2 JDMF, 6 EU WC, 2 KDMF, 8 NDC API, 24 Listed Suppliers, $ API Reference Price

33 API Suppliers
10 USDMF
12 CEP/COS
2 JDMF
6 EU WC
2 KDMF
8 NDC API
24 Listed Suppliers
$ API Reference Price

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

17 API Suppliers

17 API Suppliers

FINISHED DOSAGE FORMULATIONS

147 FDF Dossiers, 49 FDA Orange Book, 44 Europe, 15 Canada, 7 Australia, 11 South Africa, 21 Listed Dossiers

147 FDF Dossiers
49 FDA Orange Book
44 Europe
15 Canada
7 Australia
11 South Africa
21 Listed Dossiers

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 1 DKSH, 2 Jai Radhe Sales, 4 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 6 Actylis, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 12 BASF, 7 DFE Pharma, 1 Finar, 9 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 26 Kerry, 14 Microlex e.U, 1 Nanjing Bold Chemical, 1 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 21 Roquette, 7 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 2 Ulanqab Kema New Material, 4 Vasa Pharmachem

4 SPI Pharma
1 DKSH
2 Jai Radhe Sales
4 Boai NKY Pharmaceuticals Ltd
13 Gangwal Healthcare
3 Nanjing Well Pharmaceutical
6 Actylis
8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
12 BASF
7 DFE Pharma
1 Finar
9 Gangwal Chemicals
1 Ideal Cures Pvt Ltd
4 Ingredion Pharma Solutions
26 Kerry
14 Microlex e.U
1 Nanjing Bold Chemical
1 Novo Excipients
3 Pharmatrans-Sanaq
6 Pluviaendo
4 Prachin Chemical
21 Roquette
7 Seppic
5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
11 Sigachi Industries
2 Ulanqab Kema New Material
4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

72 Fillers, Diluents & Binders, 34 Direct Compression, 29 Disintegrants & Superdisintegrants, 20 Solubilizers, 19 Granulation, 19 Co-Processed Excipients, 18 Thickeners and Stabilizers, 16 Lubricants & Glidants, 12 Parenteral, 11 Controlled & Modified Release, 9 Coating Systems & Additives, 8 Film Formers & Plasticizers, 7 Taste Masking, 7 Emulsifying Agents, 6 Topical, 5 Chewable & Orodispersible Aids, 3 Rheology Modifiers, 3 API Stability Enhancers, 2 Surfactant & Foaming Agents, 1 Dry Powder Inhalation

72 Fillers, Diluents & Binders
34 Direct Compression
29 Disintegrants & Superdisintegrants
20 Solubilizers
19 Granulation
19 Co-Processed Excipients
18 Thickeners and Stabilizers
16 Lubricants & Glidants
12 Parenteral
11 Controlled & Modified Release
9 Coating Systems & Additives
8 Film Formers & Plasticizers
7 Taste Masking
7 Emulsifying Agents
6 Topical
5 Chewable & Orodispersible Aids
3 Rheology Modifiers
3 API Stability Enhancers
2 Surfactant & Foaming Agents
1 Dry Powder Inhalation

DIGITAL CONTENT

26 NEWS #PharmaBuzz

26 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 47 Finished Drug Prices, 3 Annual Reports

1 US Medicaid Prescriptions
47 Finished Drug Prices
3 Annual Reports

MARKET PLACE

15 APIs, 22 FDF Dossiers

15 APIs
22 FDF Dossiers

PATENTS & EXCLUSIVITIES

3 US Patents

3 US Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 4 USP, 16 Others

3 EDQM
4 USP
16 Others

$ API Ref.Price (USD/KG) : 145 Xls

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10 All

01 1PMC Isochem

02 1Taro Pharmaceutical Industries

03 1Aurobindo Pharma Limited

04 1CTX Lifesciences

05 1Cambrex Corporation

06 1Emcure Pharmaceuticals

07 1Glenmark Life Sciences

08 1Hainan Poly Pharm

09 1Piramal Pharma Solutions

10 1Unichem Laboratories Limited

filter Subject Reset all filters

10 All

01 1AMIODARONE HCL

02 1AMIODARONE HCL USP

03 3AMIODARONE HYDROCHLORIDE

04 5AMIODARONE HYDROCHLORIDE USP

filter Country Reset all filters

10 All

01 1China

02 1France

03 5India

04 3U.S.A

filter Status Reset all filters

10 All

01 9Active

02 1Inactive

filter GDUFA DMF Review Reset all filters

10 All

01 6Complete

02 4Blank

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

List of Suppliers

Product Main Page

01

Pmc Isochem

CPhI Worldwide, Milan

PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.

Contact Supplier

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Digital Content

Amiodarone Hydrochloride

GDUFA

DMF Review : Complete

Rev. Date : 2013-02-26

Pay. Date : 2013-02-13

DMF Number : 7617

Submission : 1988-08-02

Status : Active

Type : II

Product Web Link

Digital Content

02

Taro Pharmaceutical Industries Ltd

Formnext Forum

Not Confirmed

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Digital Content

Amiodarone Hcl Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 15794

Submission : 2001-12-27

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Aurobindo Pharma Ltd

USDMF

Formnext Forum

Not Confirmed

03

Aurobindo Pharma Ltd

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Not Confirmed

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Digital Content

Amiodarone Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17217

Submission : 2004-03-05

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

04

Cambrex Profarmaco Milano Srl

USDMF

Formnext Forum

Not Confirmed

04

Cambrex Profarmaco Milano Srl

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Not Confirmed

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Digital Content

Amiodarone Hcl

GDUFA

DMF Review : Complete

Rev. Date : 2016-07-15

Pay. Date : 2016-06-17

DMF Number : 3505

Submission : 1979-04-11

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Ctx Life Sciences Pvt Ltd

USDMF

Formnext Forum

Not Confirmed

05

Ctx Life Sciences Pvt Ltd

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Digital Content

Amiodarone Hydrochloride Usp

GDUFA

DMF Review : Complete

Rev. Date : 2016-05-24

Pay. Date : 2015-09-11

DMF Number : 25892

Submission : 2012-04-09

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Emcure Pharmaceuticals Ltd

USDMF

Formnext Forum

Not Confirmed

06

Emcure Pharmaceuticals Ltd

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Digital Content

Amiodarone Hydrochloride Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38160

Submission : 2023-05-11

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

07

Glenmark Life Sciences Ltd

USDMF

Formnext Forum

Not Confirmed

07

Glenmark Life Sciences Ltd

Formnext Forum

Not Confirmed

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Digital Content

Amiodarone Hydrochloride Usp

GDUFA

DMF Review : Complete

Rev. Date : 2019-03-28

Pay. Date : 2019-03-25

DMF Number : 16787

Submission : 2003-08-27

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Hainan Poly Pharm Co Ltd

USDMF

Formnext Forum

Not Confirmed

08

Hainan Poly Pharm Co Ltd

Formnext Forum

Not Confirmed

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Digital Content

Amiodarone Hydrochloride Usp

GDUFA

DMF Review : Complete

Rev. Date : 2021-10-20

Pay. Date : 2021-09-07

DMF Number : 36163

Submission : 2021-09-07

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

09

Piramal Pharma Ltd

USDMF

Formnext Forum

Not Confirmed

09

Piramal Pharma Ltd

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Digital Content

Amiodarone Hydrochloride

GDUFA

DMF Review : Complete

Rev. Date : 2013-09-21

Pay. Date : 2013-09-10

DMF Number : 21694

Submission : 2008-06-12

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Unichem Laboratories Ltd

USDMF

Formnext Forum

Not Confirmed

10

Unichem Laboratories Ltd

Formnext Forum

Not Confirmed

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Digital Content

Amiodarone Hydrochloride Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 33688

Submission : 2019-03-22

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

Tox21_300395 Manufacturers | Traders | Suppliers

Tox21_300395 Manufacturers, Traders, Suppliers 1

66

We have 10 companies offering Tox21_300395

Get in contact with the supplier of your choice:

PMC Isochem
Taro Pharmaceutical Industries
Aurobindo Pharma Limited
Cambrex Corporation
CTX Lifesciences
Emcure Pharmaceuticals
Glenmark Life Sciences
Hainan Poly Pharm
Piramal Pharma Solutions
Unichem Laboratories Limited

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