Find Elamipretide manufacturers, exporters & distributors on PharmaCompass

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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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API Suppliers

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USDMF

US DMFs Filed

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CEP/COS

CEP/COS Certifications

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JDMF

JDMFs Filed

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EU WC

EU WC

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KDMF

KDMF

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VMF

NDC API

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Listed Suppliers

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API REF. PRICE (USD/KG)

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MARKET PLACE

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API

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FDF

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FINISHED DOSAGE FORMULATIONS

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FDA Orange Book

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Europe

Europe

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Canada

Canada

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Australia

Australia

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South Africa

South Africa

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Listed Dossiers

Listed Dossiers

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DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

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Others

PATENTS & EXCLUSIVITIES

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US Patents

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Health Canada Patents

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Data Compilation #PharmaFlow

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Stock Recap #PipelineProspector

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GLOBAL SALES INFORMATION

US Medicaid

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Chemistry

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Also known as: 736992-21-5, Bendavia, Mtp-131, Ocuvia, Mtp 131, Rx 31
Molecular Formula
C32H49N9O5
Molecular Weight
639.8  g/mol
InChI Key
SFVLTCAESLKEHH-WKAQUBQDSA-N
FDA UNII
87GWG91S09

Elamipretide
Elamipretide has been used in trials studying the treatment of Leber's Hereditary Optic Neuropathy.
1 2D Structure

Elamipretide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-6-amino-2-[[(2S)-2-[[(2R)-2-amino-5-(diaminomethylideneamino)pentanoyl]amino]-3-(4-hydroxy-2,6-dimethylphenyl)propanoyl]amino]-N-[(2S)-1-amino-1-oxo-3-phenylpropan-2-yl]hexanamide
2.1.2 InChI
InChI=1S/C32H49N9O5/c1-19-15-22(42)16-20(2)23(19)18-27(41-29(44)24(34)11-8-14-38-32(36)37)31(46)39-25(12-6-7-13-33)30(45)40-26(28(35)43)17-21-9-4-3-5-10-21/h3-5,9-10,15-16,24-27,42H,6-8,11-14,17-18,33-34H2,1-2H3,(H2,35,43)(H,39,46)(H,40,45)(H,41,44)(H4,36,37,38)/t24-,25+,26+,27+/m1/s1
2.1.3 InChI Key
SFVLTCAESLKEHH-WKAQUBQDSA-N
2.1.4 Canonical SMILES
CC1=CC(=CC(=C1CC(C(=O)NC(CCCCN)C(=O)NC(CC2=CC=CC=C2)C(=O)N)NC(=O)C(CCCN=C(N)N)N)C)O
2.1.5 Isomeric SMILES
CC1=CC(=CC(=C1C[C@@H](C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC2=CC=CC=C2)C(=O)N)NC(=O)[C@@H](CCCN=C(N)N)N)C)O
2.2 Other Identifiers
2.2.1 UNII
87GWG91S09
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Arg-dmt-lys-phe-nh2

2. Arginyl-2,'6'-dimethyltyrosyl-lysyl-phenylalaninamide

3. Bendavia

4. D-arg-dmt-lys-phe-nh2

5. Mtp-131

6. Ss-31 Peptide

7. Ss31 Peptide

2.3.2 Depositor-Supplied Synonyms

1. 736992-21-5

2. Bendavia

3. Mtp-131

4. Ocuvia

5. Mtp 131

6. Rx 31

7. Ss 31

8. L-phenylalaninamide, D-arginyl-2,6-dimethyl-l-tyrosyl-l-lysyl-

9. Unii-87gwg91s09

10. Szeto-schiller Peptide

11. Rx-31

12. Ss-31

13. Nh2-d-arg-dmt-lys-phe-nh2

14. 87gwg91s09

15. D-arginyl-2,6-dimethyl-l-tyrosyl-l-lysyl-l-phenylalaninamide

16. (2s)-6-amino-2-[[(2s)-2-[[(2r)-2-amino-5-(diaminomethylideneamino)pentanoyl]amino]-3-(4-hydroxy-2,6-dimethylphenyl)propanoyl]amino]-n-[(2s)-1-amino-1-oxo-3-phenylpropan-2-yl]hexanamide

17. (s)-6-amino-n-((s)-1-amino-1-oxo-3-phenylpropan-2-yl)-2-((s)-2-((r)-2-amino-5-guanidinopentanamido)-3-(4-hydroxy-2,6-dimethylphenyl)propanamido)hexanamide

18. Ss-31 Peptide

19. Arg-dmt-lys-phe-nh2

20. D-arg-dmt-lys-phe-nh2

21. Ss31 Peptide

22. Elamipretide [inn]

23. Elamipretide [usan:inn]

24. Elamipretide (usan/inn)

25. Elamipretide [usan]

26. Elamipretide (mtp-131)

27. Elamipretide [who-dd]

28. Arginyl-2,'6'-dimethyltyrosyl-lysyl-phenylalaninamide

29. Chembl3833370

30. Schembl15028020

31. Dtxsid50471988

32. Ss-31mtp-131

33. Hy-p0125

34. S9803

35. Zinc43130902

36. Cs-5846

37. Db11981

38. D10925

39. D78262

40. A901134

41. Q27269822

2.4 Create Date
2006-10-26
3 Chemical and Physical Properties
Molecular Weight 639.8 g/mol
Molecular Formula C32H49N9O5
XLogP30
Hydrogen Bond Donor Count9
Hydrogen Bond Acceptor Count8
Rotatable Bond Count19
Exact Mass639.38566570 g/mol
Monoisotopic Mass639.38566570 g/mol
Topological Polar Surface Area267 Ų
Heavy Atom Count46
Formal Charge0
Complexity991
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

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ABOUT THIS PAGE

Elamipretide Manufacturers

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

Elamipretide Suppliers

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

Elamipretide NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Elamipretide as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Elamipretide API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Elamipretide as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Elamipretide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Elamipretide NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Elamipretide suppliers with NDC on PharmaCompass.

Elamipretide GMP

Elamipretide Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

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

Elamipretide CoA

A Elamipretide CoA (Certificate of Analysis) is a formal document that attests to Elamipretide's compliance with Elamipretide specifications and serves as a tool for batch-level quality control.

Elamipretide CoA mostly includes findings from lab analyses of a specific batch. For each Elamipretide CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Elamipretide may be tested according to a variety of international standards, such as European Pharmacopoeia (Elamipretide EP), Elamipretide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Elamipretide USP).

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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