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List of Drug Master Files (DMF) of AM20060525 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

AM20060525
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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AM20060525

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 19 USDMF, 1 EU WC, 8 NDC API, 12 Listed Suppliers, $ API Reference Price

26 API Suppliers
19 USDMF
1 EU WC
8 NDC API
12 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

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

13 FDF Dossiers, 12 FDA Orange Book, 1 Listed Dossiers

13 FDF Dossiers
12 FDA Orange Book
1 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 800MG

TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 800MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Rochem International Inc, 8 SPI Pharma, 3 DKSH, 1 Jai Radhe Sales, 6 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 13 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 1 Aeon Procare, 3 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 19 BASF, 11 Corel Pharma Chem, 5 DFE Pharma, 7 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 6 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 29 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 NEWEDGE Overseas, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 19 Roquette, 7 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 10 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

78 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 41 Direct Compression, 28 Controlled & Modified Release, 27 Lubricants & Glidants, 25 Disintegrants & Superdisintegrants, 24 Granulation, 22 Thickeners and Stabilizers, 16 Film Formers & Plasticizers, 16 Co-Processed Excipients, 14 Solubilizers, 11 Taste Masking, 10 Chewable & Orodispersible Aids, 7 Emulsifying Agents, 6 API Stability Enhancers, 5 Empty Capsules, 5 Rheology Modifiers, 4 Vegetarian Capsules, 3 Parenteral, 2 Coloring Agents, 2 Topical, 1 Surfactant & Foaming Agents

78 Fillers, Diluents & Binders
51 Coating Systems & Additives
41 Direct Compression
28 Controlled & Modified Release
27 Lubricants & Glidants
25 Disintegrants & Superdisintegrants
24 Granulation
22 Thickeners and Stabilizers
16 Film Formers & Plasticizers
16 Co-Processed Excipients
14 Solubilizers
11 Taste Masking
10 Chewable & Orodispersible Aids
7 Emulsifying Agents
6 API Stability Enhancers
5 Empty Capsules
5 Rheology Modifiers
4 Vegetarian Capsules
3 Parenteral
2 Coloring Agents
2 Topical
1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 6 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
6 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions

2 US Medicaid Prescriptions

MARKET PLACE

4 APIs

4 APIs

PATENTS & EXCLUSIVITIES

2 US Patents

2 US Patents

REF. STANDARDS & IMPURITIES

3 USP, 4 Others

3 USP
4 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 149 Xls

Filters

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Filters

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19 All

01 1Cohance Lifesciences

02 1Angelini Pharma

03 1Arevipharma

04 1Boehringer Ingelheim GmbH

05 1Corden Pharma Bergamo S.p.A

06 1FDC

07 1Fresenius Kabi Oncology Limited

08 1Hetero Drugs

09 1Innovare Labs

10 1KLIO Pharma

11 1Lupin Ltd

12 1Piramal Pharma Solutions

13 1Raks Pharma

14 1Roche Diagnostics GmbH

15 1Sun Pharmaceutical Industries Limited

16 1Syn-Tech Chem. & Pharm

17 2Zhejiang Apeloa Jiayuan Pharmaceutical

18 1Blank

filter Subject Reset all filters

19 All

01 11METAXALONE

02 1METAXALONE API

03 7METAXALONE USP

filter Country Reset all filters

19 All

01 2China

02 3Germany

03 9India

04 2Italy

05 1Taiwan

06 1U.S.A

07 1Blank

filter Status Reset all filters

19 All

01 11Active

02 8Inactive

filter GDUFA DMF Review Reset all filters

19 All

01 8Complete

02 11Blank

API Suppliers
USDMF
EU WC
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Cohance Lifesciences Ltd

CPhI Worldwide, Milan

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Contact Supplier

Contact Supplier

Digital Content

Metaxalone Usp

GDUFA

DMF Review : Complete

Rev. Date : 2016-04-06

Pay. Date : 2015-09-22

DMF Number : 21251

Submission : 2008-01-15

Status : Active

Type : II

Product Web Link

Digital Content

02

Angelini Acraf Spa

USDMF

Formnext Forum

Not Confirmed

02

Angelini Acraf Spa

Formnext Forum

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 : Complete

Rev. Date : 2013-02-26

Pay. Date : 2013-02-11

DMF Number : 15100

Submission : 2000-10-19

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Rising Pharma Holdings Inc

USDMF

Formnext Forum

Not Confirmed

03

Rising Pharma Holdings Inc

Formnext Forum

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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Post an Enquiry

Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2013-02-26

Pay. Date : 2013-02-04

DMF Number : 15087

Submission : 2000-10-11

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Hetero Drugs Ltd

USDMF

Formnext Forum

Not Confirmed

04

Hetero Drugs Ltd

Formnext Forum

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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Post an Enquiry

Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2014-07-14

Pay. Date : 2014-03-24

DMF Number : 28062

Submission : 2014-02-28

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Innovare Labs Private Ltd

USDMF

Formnext Forum

Not Confirmed

05

Innovare Labs Private Ltd

Formnext Forum

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

Metaxalone Usp

GDUFA

DMF Review : Complete

Rev. Date : 2022-03-29

Pay. Date : 2022-03-09

DMF Number : 36167

Submission : 2021-09-30

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Piramal Pharma Ltd

USDMF

Formnext Forum

Not Confirmed

06

Piramal Pharma Ltd

Formnext Forum

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

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 27105

Submission : 2013-04-26

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Raks Pharma Pvt Ltd

USDMF

Formnext Forum

Not Confirmed

07

Raks Pharma Pvt Ltd

Formnext Forum

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

Metaxalone Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 23980

Submission : 2010-07-19

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

08

Sun Pharmaceutical Industries Ltd

USDMF

Formnext Forum

Not Confirmed

08

Sun Pharmaceutical Industries Ltd

Formnext Forum

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

Metaxalone Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 31859

Submission : 2017-10-24

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Syn-tech Chem And Pharm Co Ltd

USDMF

Formnext Forum

Not Confirmed

09

Syn-tech Chem And Pharm Co Ltd

Formnext Forum

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

Metaxalone Usp

GDUFA

DMF Review : Complete

Rev. Date : 2014-06-16

Pay. Date : 2014-03-06

DMF Number : 24631

Submission : 2011-02-04

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Zhejiang Apeloa Jiayuan Pharmaceutic...

USDMF

Formnext Forum

Not Confirmed

10

Zhejiang Apeloa Jiayuan Pharmaceutic...

Formnext Forum

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 : Complete

Rev. Date : 2013-12-05

Pay. Date : 2013-08-01

DMF Number : 25533

Submission : 2011-11-21

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

1
2

AM20060525 Manufacturers | Traders | Suppliers

AM20060525 Manufacturers, Traders, Suppliers 1

55

We have 17 companies offering AM20060525

Get in contact with the supplier of your choice:

Cohance Lifesciences
Angelini Pharma
Arevipharma
Boehringer Ingelheim GmbH
Corden Pharma Bergamo S.p.A
FDC
Fresenius Kabi Oncology Limited
Hetero Drugs
Innovare Labs
KLIO Pharma
Lupin Ltd
Piramal Pharma Solutions
Raks Pharma
Roche Diagnostics GmbH
Sun Pharmaceutical Industries Limited
Syn-Tech Chem. & Pharm
Zhejiang Apeloa Jiayuan Pharmaceutical

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