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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

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01 Auro Peptides Limited (1)

02 CordenPharma (1)

03 GLAND PHARMA LIMITED (1)

04 Hybio Pharmaceutical (1)

05 Teva API (1)

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

02 GLATIRAMER ACETATE (3)

03 GLATIRAMER ACETATE, NON-STERILE BULK DRUG SUBSTANCE (1)

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01 China (1)

02 Germany (1)

03 India (2)

04 Israel (1)

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01 Active (4)

02 Inactive (1)

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01 Complete (3)

02 Blank (2)

URL Supplier Web Content
35493
Active
2020-12-25
Complete
2021-02-08
2020-12-24
II
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URL Supplier Web Content
27723
Active
2013-12-12
Complete
2014-06-05
2013-11-22
II
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URL Supplier Web Content
33092
Active
2018-09-12
N/A
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URL Supplier Web Content
28989
Active
2014-12-25
Complete
2018-03-07
2018-02-09
II
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URL Supplier Web Content
7609
Inactive
1988-08-02
N/A
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Looking for 147245-92-9 / Glatiramer Acetate API manufacturers, exporters & distributors?

Glatiramer Acetate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Glatiramer Acetate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Glatiramer Acetate manufacturer or Glatiramer Acetate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Glatiramer Acetate manufacturer or Glatiramer Acetate supplier.

PharmaCompass also assists you with knowing the Glatiramer Acetate API Price utilized in the formulation of products. Glatiramer Acetate API Price is not always fixed or binding as the Glatiramer Acetate Price is obtained through a variety of data sources. The Glatiramer Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Glatiramer Acetate

Synonyms

147245-92-9, Acetic acid;(2s)-2-amino-3-(4-hydroxyphenyl)propanoic acid;(2s)-2-aminopentanedioic acid;(2s)-2-aminopropanoic acid;(2s)-2,6-diaminohexanoic acid, Glatirameracetat, Dtxsid30163637, Am84438, Ac-28732

Cas Number

147245-92-9

About Glatiramer Acetate

A random polymer of L-ALANINE, L-GLUTAMIC ACID, L-LYSINE, and L-TYROSINE that structurally resembles MYELIN BASIC PROTEIN. It is used in the treatment of RELAPSING-REMITTING MULTIPLE SCLEROSIS.

Copaxone Manufacturers

A Copaxone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Copaxone, including repackagers and relabelers. The FDA regulates Copaxone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Copaxone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Copaxone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Copaxone Suppliers

A Copaxone supplier is an individual or a company that provides Copaxone active pharmaceutical ingredient (API) or Copaxone finished formulations upon request. The Copaxone suppliers may include Copaxone API manufacturers, exporters, distributors and traders.

click here to find a list of Copaxone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Copaxone USDMF

A Copaxone DMF (Drug Master File) is a document detailing the whole manufacturing process of Copaxone active pharmaceutical ingredient (API) in detail. Different forms of Copaxone DMFs exist exist since differing nations have different regulations, such as Copaxone USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Copaxone DMF submitted to regulatory agencies in the US is known as a USDMF. Copaxone USDMF includes data on Copaxone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Copaxone USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Copaxone suppliers with USDMF on PharmaCompass.

Copaxone Manufacturers | Traders | Suppliers

Copaxone Manufacturers, Traders, Suppliers 1
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We have 5 companies offering Copaxone

Get in contact with the supplier of your choice:

  1. Auro Peptides Limited
  2. CordenPharma
  3. GLAND PHARMA LIMITED
  4. Hybio Pharmaceutical
  5. Teva API
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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