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Thymalfasin

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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ACTIVE PHARMA INGREDIENTS

9 API Suppliers, 4 USDMF, 8 KDMF, 2 NDC API, 5 Listed Suppliers, $ API Reference Price

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Synopsis

ACTIVE PHARMA INGREDIENTS

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Chemistry

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Also known as: 62304-98-7, Zadaxin, Thymosin alpha 1, Thymosin alpha1, Thymosin-alpha-1, 69440-99-9

Molecular Formula

C₁₂₉H₂₁₅N₃₃O₅₅

Molecular Weight

3108.3 g/mol

InChI Key

NZVYCXVTEHPMHE-ZSUJOUNUSA-N

A thymus hormone polypeptide found in thymosin fraction 5 (a crude thymus gland extract) but now produced by synthesis. It is used alone or with interferon as an immunomodulator for the treatment of CHRONIC HEPATITIS B and HEPATITIS C. Thymalfasin is also used for the treatment of chemotherapy-induced immunosuppression, and to enhance the efficacy of influenza and hepatitis B vaccines in immunocompromised patients.

1 2D Structure

Thymalfasin

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(4S)-4-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S,3R)-2-[[(2S,3S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-acetamido-3-hydroxypropanoyl]amino]-3-carboxypropanoyl]amino]propanoyl]amino]propanoyl]amino]-3-methylbutanoyl]amino]-3-carboxypropanoyl]amino]-3-hydroxybutanoyl]amino]-3-hydroxypropanoyl]amino]-3-hydroxypropanoyl]amino]-4-carboxybutanoyl]amino]-3-methylpentanoyl]amino]-3-hydroxybutanoyl]amino]-3-hydroxybutanoyl]amino]-6-aminohexanoyl]amino]-3-carboxypropanoyl]amino]-4-methylpentanoyl]amino]-6-aminohexanoyl]amino]-4-carboxybutanoyl]amino]-6-aminohexanoyl]amino]-6-aminohexanoyl]amino]-4-carboxybutanoyl]amino]-3-methylbutanoyl]amino]-3-methylbutanoyl]amino]-4-carboxybutanoyl]amino]-4-carboxybutanoyl]amino]propanoyl]amino]-5-[[(1S)-3-amino-1-carboxy-3-oxopropyl]amino]-5-oxopentanoic acid

2.1.2 InChI

InChI=1S/C129H215N33O55/c1-18-59(10)98(159-114(201)76(36-42-91(181)182)146-120(207)83(53-164)154-121(208)84(54-165)155-127(214)99(63(14)166)160-118(205)80(51-94(187)188)152-123(210)95(56(4)5)156-104(191)62(13)135-102(189)60(11)137-115(202)78(49-92(183)184)151-119(206)82(52-163)138-66(17)169)125(212)161-101(65(16)168)128(215)162-100(64(15)167)126(213)147-70(30-22-26-46-133)109(196)150-79(50-93(185)186)117(204)149-77(47-55(2)3)116(203)142-69(29-21-25-45-132)108(195)144-73(33-39-88(175)176)110(197)141-67(27-19-23-43-130)106(193)140-68(28-20-24-44-131)107(194)145-75(35-41-90(179)180)113(200)157-97(58(8)9)124(211)158-96(57(6)7)122(209)148-74(34-40-89(177)178)111(198)143-71(31-37-86(171)172)105(192)136-61(12)103(190)139-72(32-38-87(173)174)112(199)153-81(129(216)217)48-85(134)170/h55-65,67-84,95-101,163-168H,18-54,130-133H2,1-17H3,(H2,134,170)(H,135,189)(H,136,192)(H,137,202)(H,138,169)(H,139,190)(H,140,193)(H,141,197)(H,142,203)(H,143,198)(H,144,195)(H,145,194)(H,146,207)(H,147,213)(H,148,209)(H,149,204)(H,150,196)(H,151,206)(H,152,210)(H,153,199)(H,154,208)(H,155,214)(H,156,191)(H,157,200)(H,158,211)(H,159,201)(H,160,205)(H,161,212)(H,162,215)(H,171,172)(H,173,174)(H,175,176)(H,177,178)(H,179,180)(H,181,182)(H,183,184)(H,185,186)(H,187,188)(H,216,217)/t59-,60-,61-,62-,63+,64+,65+,67-,68-,69-,70-,71-,72-,73-,74-,75-,76-,77-,78-,79-,80-,81-,82-,83-,84-,95-,96-,97-,98-,99-,100-,101-/m0/s1

2.1.3 InChI Key

NZVYCXVTEHPMHE-ZSUJOUNUSA-N

2.1.4 Canonical SMILES

CCC(C)C(C(=O)NC(C(C)O)C(=O)NC(C(C)O)C(=O)NC(CCCCN)C(=O)NC(CC(=O)O)C(=O)NC(CC(C)C)C(=O)NC(CCCCN)C(=O)NC(CCC(=O)O)C(=O)NC(CCCCN)C(=O)NC(CCCCN)C(=O)NC(CCC(=O)O)C(=O)NC(C(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CCC(=O)O)C(=O)NC(CC(=O)N)C(=O)O)NC(=O)C(CCC(=O)O)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CC(=O)O)NC(=O)C(C(C)C)NC(=O)C(C)NC(=O)C(C)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C

2.1.5 Isomeric SMILES

CC[C@H](C)[C@@H](C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(=O)O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CC(=O)N)C(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](C(C)C)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)C

2.2 Synonyms

2.2.1 MeSH Synonyms

1. Alpha1 Thymosin

2. Alpha1-thymosin

3. Thymosin Alpha(1)

4. Thymosin Alpha1

5. Zadaxin

2.2.2 Depositor-Supplied Synonyms

1. 62304-98-7

2. Zadaxin

3. Thymosin Alpha 1

4. Thymosin Alpha1

5. Thymosin-alpha-1

6. 69440-99-9

7. N-acetyl-l-seryl-l-alpha-aspartyl-l-alanyl-l-alanyl-l-valyl-l-alpha-aspartyl-l-threonyl-l-seryl-l-seryl-l-alpha-glutamyl-l-isoleucyl-l-threonyl-l-threonyl-l-lysyl-l-alpha-aspartyl-l-leucyl-l-lysyl-l-alpha-glutamyl-l-lysyl-l-lysyl-l-alpha-glutamyl-l-valyl-l-valyl-l-alpha-glutamyl-l-alpha-glutamyl-l-alanyl-l-alpha-glutamyl-l-asparagine

8. 69521-94-4

9. Thymosin Alpha1 (ox)

10. Thymosin Alpha1 (human)

11. Alpha1-thymosin

12. Thymalfasin [usan:inn]

13. Thymosin Alpha(1)

14. Thymosin Alpha1 Acetate

15. Thymosin Alpha1 (cattle)

16. Unii-w0b22isq1c

17. Thymlfasin

18. Thymosin

19. A1

20. Thymosin .alpha.1

21. Thymosins Thymalfasin

22. Thymosin A1 (cattle)

23. Thymosin A1thymosin A1

24. Thymosin I+/-1 Bovine

25. Alpha1-thymosinthymalfasin

26. W0b22isq1c

27. .alpha.1-thymosinthymalfasin

28. Thymosin .alpha.1 (cattle)

29. Ccris 7707

30. Emz702

31. Chembl2103979

32. Schembl15531955

33. Dtxsid80211374

34. Chebi:135915

35. Thymosin-alpha-1 & .alpha. Ifn

36. Akos015994639

37. Hs-2030

38. L-asparagine, N-acetyl-l-seryl-l-alpha-aspartyl-l-alanyl-l-alanyl-l-valyl-l-alpha-asparatyl-l-threonyl-l-seryl-l-seryl-l-alpha-glutamyl-l-isoleucyl-l-threonyl-l-threonyl-l-lysyl-l-alpha-aspartyl-l-leucyl-l-lysyl-l-alpha-glutamyl-l-lysyl-l-lysyl-l-alpha-glutamyl-l-valyl-l-valyl-l-alpha-glutamyl-l-alpha-glutamyl-l-alanyl-l-alpha-glutamyl-

39. Thymosin Alpha1 Bovine, >=90% (hplc)

40. Ac-sdaavdtsseittkdlkekkevveeaen-cooh

41. 304t987

42. Ac-ser-asp-ala-ala-val-asp-thr-ser-ser-glu-ile-thr-thr-lys-asp-leu-lys-glu-lys-lys-glu-val-val-glu-glu-ala-glu-asn-oh

2.3 Create Date

2007-07-03

3 Chemical and Physical Properties

Molecular Formula	C₁₂₉H₂₁₅N₃₃O₅₅
Molecular Weight	3108.3 g/mol
XLogP3	-24
Hydrogen Bond Donor Count	49
Hydrogen Bond Acceptor Count	59
Rotatable Bond Count	111
Exact Mass	3107.5074829 g/mol
Monoisotopic Mass	3106.5041281 g/mol
Topological Polar Surface Area	1460 Å²
Heavy Atom Count	217
Formal Charge	0
Complexity	7190
Isotope Atom Count	0
Defined Atom Stereocenter Count	32
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Indication

Indicated as an adjuvant for influenza vaccine in elderly patients and as an adjuvant for both influenza and hepatitis B vaccines in chronic hemodialysis patients who failed to achieve adequate antibody titers from previous immunization.

Investigated for use/treatment in hepatitis (viral, C).

5 Pharmacology and Biochemistry

5.1 Pharmacology

Thymalfasin is a 28-amino acid polypeptide produced synthetically but originally isolated from thymosin fraction 5, a bovine thymus extract containing a number of immunologically active peptides. In vitro studies have shown that Thymalfasin can influence T-cell production and maturation, stimulate production of Th1 cytokines such as interferon-gamma and interleukin-2, and activate natural killer cell-mediated cytotoxicity.

5.2 MeSH Pharmacological Classification

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.)

5.3 Absorption, Distribution and Excretion

Absorption

Rapidly absorbed with peak serum levels achieved at approximately 2 hours.

5.4 Biological Half-Life

Approximately 2 hours. There is no evidence of accumulation following multiple subcutaneous doses.

5.5 Mechanism of Action

The mechanism of action of thymalfasin is not completely understood but is thought to be related to its immunomodulating activities, centered primarily around augmentation of T-cell function. In various in vitro assays, thymosin alpha 1 has been shown to promote T-cell differentiation and maturation; for example, CD4+, CD8+, and CD3+ cells have all been shown to be increased. Thymosin alpha 1 has also been shown to increase production of IFN-g, IL-2, IL-3, and expression of IL-2 receptor following activation by mitogens or antigens, increase NK cell activity, increase production of migratory inhibitory factor (MIF), and increase antibody response to T-cell dependent antigens. Thymosin alpha 1 has also been shown to antagonize dexamethasone-induced apoptosis of thymocytes in vitro. In vivo administration of thymosin alpha 1 to animals immunosuppressed by chemotherapy, tumor burden, or irradiation showed that thymosin alpha 1 protects against cytotoxic damage to bone marrow, tumor progression and opportunistic infections, thereby increasing survival time and number of survivors. Many of the in vitro and in vivo effects of thymosin alpha 1 have been interpreted as influences on either differentiation of pluripotent stem cells to thymocytes or activation of thymocytes into activated T-cells. Thymalfasin also has been shown in vitro to upregulate expression of toll like receptors (TLR) including TLR2 and TLR9 in mouse and human dendritic cells, as well as activate NF-kB and JNK/P38/AP1 pathways. Thymalfasin's activation of dendritic cells provides another possible pathway explaining thymalfasin's immunomodulatory and antiviral effects.

API SUPPLIERS

01

PolyPeptide Group

Switzerland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Biotech Showcase

Not Confirmed

02

PolyPeptide Group

Switzerland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Biotech Showcase

Not Confirmed

03

Country

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Biotech Showcase

Not Confirmed

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API Reference Price

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Thymosin Alpha 1 API needed in the U.S.A [ENA21004]

A compounding pharmacy specializing in the preparation of various health and nutrition finished formulations is looking for suppliers of Thymosin Alpha 1 API for commercial purposes. The suppliers must support this enquiry with USDMF & CoA.

31 Oct 2024

Various APIs needed in India [ENA16518]

A biotechnology company that focuses on the research, development and manufacturing of immunosuppressants, antibiotics, oncology, anti-obesity, hypolipemic segments & enzymes is looking for suppliers of Various APIs for commercial purposes. The required quantity is MOQ for each. The suppliers must support this enquiry with CoA. 1. Sterile & IP Grade Methylprednisolone Acetate API 2. IP Grade Methylprednisolone Sodium Succinate API 3. IP Grade Voriconazole API 4. IP Grade Thymosin Alpha-1 API

02 Mar 2023

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ABOUT THIS PAGE

Thymalfasin Manufacturers

A Thymalfasin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Thymalfasin, including repackagers and relabelers. The FDA regulates Thymalfasin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Thymalfasin 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 Thymalfasin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Thymalfasin Suppliers

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

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

Thymalfasin USDMF

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

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

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

Thymalfasin KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Thymalfasin Drug Master File in Korea (Thymalfasin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Thymalfasin. The MFDS reviews the Thymalfasin KDMF as part of the drug registration process and uses the information provided in the Thymalfasin KDMF to evaluate the safety and efficacy of the drug.

After submitting a Thymalfasin KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Thymalfasin API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Thymalfasin suppliers with KDMF on PharmaCompass.

Thymalfasin 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 Thymalfasin as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Thymalfasin 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 Thymalfasin 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 Thymalfasin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Thymalfasin NDC to their finished compounded human drug products, they may choose to do so.

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Thymalfasin GMP

Thymalfasin 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 Thymalfasin 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 Thymalfasin GMP manufacturer or Thymalfasin GMP API supplier for your needs.

Thymalfasin CoA

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

Thymalfasin CoA mostly includes findings from lab analyses of a specific batch. For each Thymalfasin 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.

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