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Copaxone

Tofigh Daru Glatiramer Acetate

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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xyz-pharma-m-2024-10-07

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With Fermion, start the journey of your innovative API.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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xyz-pharma-m-2024-10-07

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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

FINISHED DOSAGE FORMULATIONS

55 FDF Dossiers, 9 FDA Orange Book, 33 Europe, 4 Canada, 4 Australia, 3 South Africa, 2 Listed Dossiers

55 FDF Dossiers
9 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

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

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 12 SPI Pharma, 1 Faran Shimi Pharmaceutical, 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

relatedExcipients
1 Rochem International Inc
12 SPI Pharma
1 Faran Shimi Pharmaceutical
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 Co-Processed Excipients, 4 Parenteral, 3 Disintegrants & Superdisintegrants, 3 Granulation, 1 API Stability Enhancers, 1 Thickeners and Stabilizers

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

DIGITAL CONTENT

18 DATA COMPILATION #PharmaFlow, 215 NEWS #PharmaBuzz

media
18 DATA COMPILATION #PharmaFlow
215 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

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

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

MARKET PLACE

8 APIs, 4 FDF Dossiers

marketPlace
8 APIs
4 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

patents
4 Health Canada Patents

Tofigh Daru Glatiramer Acetate

Synopsis

ACTIVE PHARMA INGREDIENTS

19

API Suppliers

5

USDMF

0

CEP/COS

CEP/COS Certifications

0

JDMF

4

EU WC

0

KDMF

8

NDC API

0

VMF

14

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 176,983

MARKET PLACE

8

API

4

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

55

FDF Dossiers

9

FDA Orange Book

FDA (Orange Book)

33

Europe

4

Canada

4

Australia

3

South Africa

2

Listed Dossiers

11DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

0

Others

PATENTS & EXCLUSIVITIES

0

US Patents

0

US Exclusivities

4

Health Canada Patents

DIGITAL CONTENT

18

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

215

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

700,867,292

Annual Reports (USD Million)

11,302

Finished Drug Prices

30 RELATED EXCIPIENT COMPANIES

61EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 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

Molecular Formula

C₂₅H₄₅N₅O₁₃

Molecular Weight

623.7 g/mol

InChI Key

FHEAIOHRHQGZPC-KIWGSFCNSA-N

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.

1 2D Structure

Glatiramer Acetate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

acetic acid;(2S)-2-amino-3-(4-hydroxyphenyl)propanoic acid;(2S)-2-aminopentanedioic acid;(2S)-2-aminopropanoic acid;(2S)-2,6-diaminohexanoic acid

2.1.2 InChI

InChI=1S/C9H11NO3.C6H14N2O2.C5H9NO4.C3H7NO2.C2H4O2/c10-8(9(12)13)5-6-1-3-7(11)4-2-6;7-4-2-1-3-5(8)6(9)10;6-3(5(9)10)1-2-4(7)8;1-2(4)3(5)6;1-2(3)4/h1-4,8,11H,5,10H2,(H,12,13);5H,1-4,7-8H2,(H,9,10);3H,1-2,6H2,(H,7,8)(H,9,10);2H,4H2,1H3,(H,5,6);1H3,(H,3,4)/t8-;5-;3-;2-;/m0000./s1

2.1.3 InChI Key

FHEAIOHRHQGZPC-KIWGSFCNSA-N

2.1.4 Canonical SMILES

CC(C(=O)O)N.CC(=O)O.C1=CC(=CC=C1CC(C(=O)O)N)O.C(CCN)CC(C(=O)O)N.C(CC(=O)O)C(C(=O)O)N

2.1.5 Isomeric SMILES

C[C@@H](C(=O)O)N.CC(=O)O.C1=CC(=CC=C1C[C@@H](C(=O)O)N)O.C(CCN)C[C@@H](C(=O)O)N.C(CC(=O)O)[C@@H](C(=O)O)N

2.2 Synonyms

2.2.1 MeSH Synonyms

1. 5010, Tv

2. Acetate, Glatiramer

3. Copaxone

4. Glatiramer

5. Tv 5010

6. Tv-5010

7. Tv5010

2.2.2 Depositor-Supplied Synonyms

1. 147245-92-9

2. Acetic Acid;(2s)-2-amino-3-(4-hydroxyphenyl)propanoic Acid;(2s)-2-aminopentanedioic Acid;(2s)-2-aminopropanoic Acid;(2s)-2,6-diaminohexanoic Acid

3. Glatirameracetat

4. Dtxsid30163637

5. Am84438

6. Ac-28732

7. L-alanine Compound With L-glutamic Acid And L-lysine And L-tyrosine And Acetic Acid (1:1:1:1:1)

8. Q418274

2.3 Create Date

2005-08-09

3 Chemical and Physical Properties

Molecular Formula	C₂₅H₄₅N₅O₁₃
Molecular Weight	623.7 g/mol
Hydrogen Bond Donor Count	12
Hydrogen Bond Acceptor Count	18
Rotatable Bond Count	13
Exact Mass	623.30138651 g/mol
Monoisotopic Mass	623.30138651 g/mol
Topological Polar Surface Area	374 Å²
Heavy Atom Count	43
Formal Charge	0
Complexity	519
Isotope Atom Count	0
Defined Atom Stereocenter Count	4
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	5

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Copaxone
PubMed Health	Glatiramer (Injection)
Drug Classes	Central Nervous System Agent, Immune Suppressant, Musculoskeletal Agent
Drug Label	Glatiramer acetate, the active ingredient of COPAXONE, consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0....
Active Ingredient	Glatiramer acetate
Dosage Form	Injectable
Route	Subcutaneous
Strength	20mg/ml; 40mg/ml
Market Status	Prescription
Company	Teva Pharms Usa

2 of 2
Drug Name	Copaxone
PubMed Health	Glatiramer (Injection)
Drug Classes	Central Nervous System Agent, Immune Suppressant, Musculoskeletal Agent
Drug Label	Glatiramer acetate, the active ingredient of COPAXONE, consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0....
Active Ingredient	Glatiramer acetate
Dosage Form	Injectable
Route	Subcutaneous
Strength	20mg/ml; 40mg/ml
Market Status	Prescription
Company	Teva Pharms Usa

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antirheumatic Agents

Drugs that are used to treat RHEUMATOID ARTHRITIS. (See all compounds classified as Antirheumatic Agents.)

Immunosuppressive Agents

Agents that suppress immune function by one of several mechanisms of action. Classical cytotoxic immunosuppressants act by inhibiting DNA synthesis. Others may act through activation of T-CELLS or by inhibiting the activation of HELPER CELLS. While immunosuppression has been brought about in the past primarily to prevent rejection of transplanted organs, new applications involving mediation of the effects of INTERLEUKINS and other CYTOKINES are emerging. (See all compounds classified as Immunosuppressive Agents.)

Adjuvants, Immunologic

Substances that augment, stimulate, activate, potentiate, or modulate the immune response at either the cellular or humoral level. The classical agents (Freund's adjuvant, BCG, Corynebacterium parvum, et al.) contain bacterial antigens. Some are endogenous (e.g., histamine, interferon, transfer factor, tuftsin, interleukin-1). Their mode of action is either non-specific, resulting in increased immune responsiveness to a wide variety of antigens, or antigen-specific, i.e., affecting a restricted type of immune response to a narrow group of antigens. The therapeutic efficacy of many biological response modifiers is related to their antigen-specific immunoadjuvanticity. (See all compounds classified as Adjuvants, Immunologic.)

5.2 ATC Code

L03AX13

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

L - Antineoplastic and immunomodulating agents

L03 - Immunostimulants

L03A - Immunostimulants

L03AX - Other immunostimulants

L03AX13 - Glatiramer acetate

API SUPPLIERS

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USDMF

01

Teva Pharmaceutical Industries Ltd

Israel

CPhI WW Frankfurt

TAPI offers customized CDMO Solutions for API development and manufacturing services.

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Israel

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

TAPI Company Banner

Product Web Link

Digital Content

Corporate PDF

02

Auro Peptides Ltd

India

CPHI Middle east

Not Confirmed

03

Amneal Pharmaceuticals Llc

Germany

CPHI Middle east

Not Confirmed

04

Gland Pharma Ltd

India

CPHI Middle east

Not Confirmed

05

Hybio Pharmaceutical Co Ltd

China

CPHI Middle east

Not Confirmed

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EU WC

01

Dr. Reddy's Laboratories

India

CPHI Middle east

Not Confirmed

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

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India

Digital Content

Glatiramer Acetate IH

Date of Issue : 2022-06-17

Valid Till : 2025-07-07

Written Confirmation Number : WC-0067

Address of the Firm : Chemical Technical Operations Unit-VI, APIIC Industrial Estate, Pydibhimavaram V...

Dr Reddy Company Banner

Product Web Link

Digital Content

02

Biocon

India

CPHI Middle east

Not Confirmed

03

GLAND PHARMA LIMITED

India

CPHI Middle east

Not Confirmed

04

Natco Pharma

India

CPHI Middle east

Not Confirmed

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NDC API

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Listed Suppliers

01

Tofigh Daru

Iran

Medlab Asia & Asia Health

Not Confirmed

Tofigh Daru develops & synthesizes a diverse range of APIs in Anticancer, Narcotics, Cardiovascular to Immunomodulatory Segments.

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Iran

Digital Content

Glatiramer Acetate

About the Company : Tofigh Daru (TODACO) belongs to the Tamin Pharmaceutical Investment Company, the biggest pharmaceutical holding in Iran. TODACO develops novel APIs in therapeutic categories like A...

Tofigh Daru (TODACO) belongs to the Tamin Pharmaceutical Investment Company, the biggest pharmaceutical holding in Iran. TODACO develops novel APIs in therapeutic categories like Anti-cancer, Anti-diabetics, Cardiovascular & Narcotics. Today, we boast to be the one & only producer of specialized APIs like Glatiramer, Fentanyl, Remifentanil, Atracurium, and peptides including long-acting Triptorelin and we have 5 PIC/s GMP-approved production lines. We also produce semi-finished products, granules for hazardous substances & FDF know-how, tech transfers & CTD compilations. We are exporting our products to Turkey, Bulgaria, Russia, & Algeria.

Product Web Link

Digital Content

02

LGM Pharma

U.S.A

Medlab Asia & Asia Health

Not Confirmed

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

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U.S.A

Digital Content

Glatiramer Acetate

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.

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Digital Content

03

HRV Global Life Sciences

India

CPHI Middle east

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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India

Digital Content

Glatiramer Acetate

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.

HRV Global Life Sciences

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04

Omgene Life Sciences Pvt. Ltd

India

Medlab Asia & Asia Health

Not Confirmed

Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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India

Digital Content

Glatiramer Acetate

About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...

Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integrated company, we focus on developing high-quality formulations based on in-house-produced actives. With GMP-certified facilities and partnerships with contract manufacturers, we excel in formulation development for injectables, lyophilized injectables, complex generics, and oral peptide delivery systems, ensuring affordable, top-quality medicines.

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05

Alembic Pharmaceuticals Limited

India

Medlab Asia & Asia Health

Not Confirmed

06

Biocon

India

Medlab Asia & Asia Health

Not Confirmed

07

GLAND PHARMA LIMITED

India

Medlab Asia & Asia Health

Not Confirmed

08

KinBio

Israel

Medlab Asia & Asia Health

Not Confirmed

09

Natco Pharma

India

Medlab Asia & Asia Health

Not Confirmed

10

Piramal Pharma Solutions

U.S.A

Medlab Asia & Asia Health

Not Confirmed

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API Reference Price

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BOULDER,CO 8030 1 USA UNITED STATES","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - FOR SOLUTION;SUBCUTANEOUS - 20MG/VIA...DOSAGE - FOR SOLUTION;SUBCUTANEOUS - 20MG/VIAL

USFDA APPLICATION NUMBER - 20622

DOSAGE - INJECTABLE;SUBCUTANEOUS - 40MG/ML

USFDA APPLICATION NUMBER - 20622

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