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

Client Email

Product

Copaxone
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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Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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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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Copaxone

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

19 API Suppliers, 5 USDMF, 4 EU WC, 8 NDC API, 14 Listed Suppliers, $ API Reference Price

19 API Suppliers
5 USDMF
4 EU WC
8 NDC API
14 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

11 Drugs in Development

11 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

FINISHED DOSAGE FORMULATIONS

53 FDF Dossiers, 7 FDA Orange Book, 33 Europe, 4 Canada, 4 Australia, 3 South Africa, 2 Listed Dossiers

53 FDF Dossiers
7 FDA Orange Book
33 Europe
4 Canada
4 Australia
3 South Africa
2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FOR SOLUTION;SUBCUTANEOUS - 20MG/VIAL, INJECTABLE;SUBCUTANEOUS - 40MG/ML

FOR SOLUTION;SUBCUTANEOUS - 20MG/VIAL
INJECTABLE;SUBCUTANEOUS - 40MG/ML

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 12 SPI Pharma, 1 Pfanstiehl, 1 BASF, 2 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 2 Kerry, 2 Microlex e.U, 1 Pluviaendo, 3 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries

1 Rochem International Inc
12 SPI Pharma
1 Pfanstiehl
1 BASF
2 Gangwal Chemicals
1 Ingredion Pharma Solutions
2 Kerry
2 Microlex e.U
1 Pluviaendo
3 Roquette
1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
1 Sigachi Industries

EXCIPIENTS BY APPLICATIONS

17 Fillers, Diluents & Binders, 10 Chewable & Orodispersible Aids, 9 Taste Masking, 9 Direct Compression, 4 Parenteral, 3 Co-Processed Excipients, 3 Granulation, 3 Disintegrants & Superdisintegrants, 1 API Stability Enhancers, 1 Thickeners and Stabilizers

17 Fillers, Diluents & Binders
10 Chewable & Orodispersible Aids
9 Taste Masking
9 Direct Compression
4 Parenteral
3 Co-Processed Excipients
3 Granulation
3 Disintegrants & Superdisintegrants
1 API Stability Enhancers
1 Thickeners and Stabilizers

DIGITAL CONTENT

18 DATA COMPILATION #PharmaFlow, 213 NEWS #PharmaBuzz

18 DATA COMPILATION #PharmaFlow
213 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 8 Finished Drug Prices, 7 Annual Reports

3 US Medicaid Prescriptions
8 Finished Drug Prices
7 Annual Reports

MARKET PLACE

8 APIs, 4 FDF Dossiers

8 APIs
4 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

4 Health Canada Patents

$ API Ref.Price (USD/KG) : 177,032 Xls

Filters

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Filters

FILTER :

filter Holder Reset all filters

5 All

01 1Auro Peptides Limited

02 1CordenPharma

03 1GLAND PHARMA LIMITED

04 1Hybio Pharmaceutical

05 1Teva API

filter Subject Reset all filters

5 All

01 1CO-POLYMER-1 (COP-1)

02 3GLATIRAMER ACETATE

03 1GLATIRAMER ACETATE, NON-STERILE BULK DRUG SUBSTANCE

filter Country Reset all filters

5 All

01 1China

02 1Germany

03 2India

04 1Israel

filter Status Reset all filters

5 All

01 4Active

02 1Inactive

filter GDUFA DMF Review Reset all filters

5 All

01 3Complete

02 2Blank

Tofigh Daru Glatiramer Acetate

API Suppliers
USDMF
EU WC
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Auro Peptides Ltd

USDMF

Luxepack

Not Confirmed

01

Auro Peptides Ltd

Luxepack

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

Glatiramer Acetate

GDUFA

DMF Review : Complete

Rev. Date : 2021-02-08

Pay. Date : 2020-12-24

DMF Number : 35493

Submission : 2020-12-25

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Amneal Pharmaceuticals Llc

USDMF

Luxepack

Not Confirmed

02

Amneal Pharmaceuticals Llc

Luxepack

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

Glatiramer Acetate

GDUFA

DMF Review : Complete

Rev. Date : 2014-06-05

Pay. Date : 2013-11-22

DMF Number : 27723

Submission : 2013-12-12

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

03

Gland Pharma Ltd

USDMF

Luxepack

Not Confirmed

03

Gland Pharma Ltd

Luxepack

Not Confirmed

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Digital Content

Glatiramer Acetate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 33092

Submission : 2018-09-12

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

04

Hybio Pharmaceutical Co Ltd

USDMF

Luxepack

Not Confirmed

04

Hybio Pharmaceutical Co Ltd

Luxepack

Not Confirmed

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Digital Content

Glatiramer Acetate, Non-sterile Bulk Drug Subs...

GDUFA

DMF Review : Complete

Rev. Date : 2018-03-07

Pay. Date : 2018-02-09

DMF Number : 28989

Submission : 2014-12-25

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

05

Teva Pharmaceutical Industries Ltd

USDMF

Luxepack

Not Confirmed

05

Teva Pharmaceutical Industries Ltd

Luxepack

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

Co-polymer-1 (cop-1)

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 7609

Submission : 1988-08-02

Status : Inactive

Type : II

Product Web Link

Digital Content

Corporate PDF

Copaxone Manufacturers | Traders | Suppliers

Copaxone Manufacturers, Traders, Suppliers 1

85

We have 5 companies offering Copaxone

Get in contact with the supplier of your choice:

Auro Peptides Limited
CordenPharma
GLAND PHARMA LIMITED
Hybio Pharmaceutical
Teva API

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