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Chemistry

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Also known as: Hyaluronic acid, sodium salt, Hyaluronic acid sodium, Kopuron, Healon, Hyalgan, Hyalurone sodium
Molecular Formula
C28H44N2NaO23+
Molecular Weight
799.6  g/mol
InChI Key
YWIVKILSMZOHHF-QJZPQSOGSA-N

Sodium Hyaluronate
A natural high-viscosity mucopolysaccharide with alternating beta (1-3) glucuronide and beta (1-4) glucosaminidic bonds. It is found in the UMBILICAL CORD, in VITREOUS BODY and in SYNOVIAL FLUID. A high urinary level is found in PROGERIA.
1 2D Structure

Sodium Hyaluronate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;(2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid
2.1.2 InChI
InChI=1S/C28H44N2O23.Na/c1-5(33)29-9-18(11(35)7(3-31)47-25(9)46)49-28-17(41)15(39)20(22(53-28)24(44)45)51-26-10(30-6(2)34)19(12(36)8(4-32)48-26)50-27-16(40)13(37)14(38)21(52-27)23(42)43;/h7-22,25-28,31-32,35-41,46H,3-4H2,1-2H3,(H,29,33)(H,30,34)(H,42,43)(H,44,45);/q;+1/t7-,8-,9-,10-,11-,12-,13+,14+,15-,16-,17-,18-,19-,20+,21+,22+,25-,26+,27-,28-;/m1./s1
2.1.3 InChI Key
YWIVKILSMZOHHF-QJZPQSOGSA-N
2.1.4 Canonical SMILES
CC(=O)NC1C(C(C(OC1O)CO)O)OC2C(C(C(C(O2)C(=O)O)OC3C(C(C(C(O3)CO)O)OC4C(C(C(C(O4)C(=O)O)O)O)O)NC(=O)C)O)O.[Na+]
2.1.5 Isomeric SMILES
CC(=O)N[C@@H]1[C@H]([C@@H]([C@H](O[C@H]1O)CO)O)O[C@H]2[C@@H]([C@H]([C@@H]([C@H](O2)C(=O)O)O[C@H]3[C@@H]([C@H]([C@@H]([C@H](O3)CO)O)O[C@H]4[C@@H]([C@H]([C@@H]([C@H](O4)C(=O)O)O)O)O)NC(=O)C)O)O.[Na+]
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Acid, Hyaluronic

2. Amo Vitrax

3. Amvisc

4. Biolon

5. Etamucine

6. Healon

7. Hyaluronate Sodium

8. Hyaluronate, Sodium

9. Hyaluronic Acid

10. Hyvisc

11. Luronit

12. Vitrax, Amo

2.2.2 Depositor-Supplied Synonyms

1. Hyaluronic Acid, Sodium Salt

2. Hyaluronic Acid Sodium

3. Kopuron

4. Healon

5. Hyalgan

6. Hyalurone Sodium

7. 6-[3-acetamido-2-[6-[3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic Acid

8. Sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic Acid

9. Equron (veterinary)

10. Synacid (veterinary)

11. Arthrease

12. Cystistat

13. Hyalart

14. Hyalein

15. Hyalovet

16. Hyladerm

17. Khionat

18. Monovisc

19. Nidelon

20. Orthovisc

21. Ostenil

22. Provisc

23. Sinovial

24. Supartz

25. Suvenyl

26. Hyasol

27. Hyladerm Khionat

28. Nrd101

29. Ha

30. Hyaluronsan Ha-lq

31. Bio Hyaluro 12

32. Euflexxa Injection

33. Euflexxa

34. Ccris 4127

35. Hyaluronate Sodium [usan:jan]

36. Sodium Hyaluronate Hmw

37. Unii-yse9ppt4th

38. Si-4402

39. Sl-1010

40. Synacid

41. Equron

42. Chlamyhyaluronic Acid Sodium Salt

43. Sl 1010

44. Hyalauronic Acid 99%

45. Yse9ppt4th

46. Gtpl4954

47. Sodium Hyaluronate (food Grade)

48. Sodium Hyaluronate (cosmetic Grade)

49. Akos015896610

50. Sodium Hyaluronate, Low Molecular Weight

51. Sodium Hyaluronate, High Molecular Weight

52. Q27078001

53. (3s,4r,5r,6r)-3-[(2s,3r,5s,6r)-3-acetamido-4-[(2s,3r,4s,6s)-6-carboxy-3,4,5-trihydroxy-tetrahydropyran-2-yl]oxy-5-hydroxy-6-(hydroxymethyl)tetrahydropyran-2-yl]oxy-6-[(3r,4r,5s,6r)-3-acetamido-2,5-dih

54. Sodium (2s,3s,4r,5r,6r)-3-{[(2s,3r,4r,5s,6r)-4-{[(2r,3r,4s,5s,6s)-6-carboxy-3,4,5-trihydroxyoxan-2-yl]oxy}-3-acetamido-5-hydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}-6-{[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy}-4,5-dihydroxyoxane-2-carboxylic Acid

2.3 Create Date
2005-08-09
3 Chemical and Physical Properties
Molecular Weight 799.6 g/mol
Molecular Formula C28H44N2NaO23+
Hydrogen Bond Donor Count14
Hydrogen Bond Acceptor Count23
Rotatable Bond Count12
Exact Mass799.22325494 g/mol
Monoisotopic Mass799.22325494 g/mol
Topological Polar Surface Area400 Ų
Heavy Atom Count54
Formal Charge1
Complexity1300
Isotope Atom Count0
Defined Atom Stereocenter Count20
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Pharmacology and Biochemistry
4.1 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.)


Viscosupplements

Viscoelastic solutions that are injected into JOINTS in order to alleviate symptoms of joint-related disorders such as OSTEOARTHRITIS. (See all compounds classified as Viscosupplements.)


4.2 FDA Pharmacological Classification
4.2.1 Pharmacological Classes
Vitamin B 6 [Chemical/Ingredient]; Vitamin B6 Analog [EPC]; Analogs/Derivatives [Chemical/Ingredient]

USDMF

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Certificate Number : CEP 2010-290 - Rev 04

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18-Jan-2022
25-Jun-2025
KGS
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Quantity (KGS) & Unit rate (USD/KGS) over time

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Drugs in Development

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Details:

M22 medical wound dressing (sodium hyaluronate) is a versatile laser treatment system based on Lumenis' medical beauty concept of "30% Laser Treatment and 70% Postoperative care.


Lead Product(s): Sodium Hyaluronate

Therapeutic Area: Trauma (Emergency, Injury, Surgery) Brand Name: M22 Medical Wound Dressing

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Lumenis

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 03, 2023

Bloomage Company Banner

01

Lead Product(s) : Sodium Hyaluronate

Therapeutic Area : Trauma (Emergency, Injury, Surgery)

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Lumenis

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : M22 medical wound dressing (sodium hyaluronate) is a versatile laser treatment system based on Lumenis' medical beauty concept of "30% Laser Treatment and 70% Postoperative care.

Product Name : M22 Medical Wound Dressing

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 03, 2023

Bloomage Company Banner

Details:

Under the agreement, BioSyent extended its agreement with its European partner for RepaGyn (sodium hyaluronate) and Proktis-M, extending its exclusive Canadian rights to these products until 2032.


Lead Product(s): Sodium Hyaluronate

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Repagyn

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Undisclosed

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement April 15, 2024

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02

KY/TN Water Professionals
Not Confirmed
KY/TN Water Professionals
Not Confirmed

Details : Under the agreement, BioSyent extended its agreement with its European partner for RepaGyn (sodium hyaluronate) and Proktis-M, extending its exclusive Canadian rights to these products until 2032.

Product Name : Repagyn

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

April 15, 2024

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Details:

Cingal (sodium hyaluronate) combination product of cross-linked hyaluronic acid (HA) proven to provide long lasting pain relief through 6 months plus TH steroid to provide fast, short-term pain relief.


Lead Product(s): Sodium Hyaluronate,Triamcinolone Hexacetonide

Therapeutic Area: Musculoskeletal Brand Name: Cingal

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 11, 2022

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03

KY/TN Water Professionals
Not Confirmed
KY/TN Water Professionals
Not Confirmed

Details : Cingal (sodium hyaluronate) combination product of cross-linked hyaluronic acid (HA) proven to provide long lasting pain relief through 6 months plus TH steroid to provide fast, short-term pain relief.

Product Name : Cingal

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

January 11, 2022

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  • Deals

Details:

NTC and I-MED Pharma’s successful collaboration to bring I-DEFENSE® innovative ophthalmic ointment first to Canada and now to the U.S.A. is a testament to the dedication of both companies to advancing the science of dry eye.


Lead Product(s): Sodium Hyaluronate

Therapeutic Area: Ophthalmology Brand Name: I-Defense

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: I-MED

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership December 15, 2021

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04

NTC

Italy
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KY/TN Water Professionals
Not Confirmed

NTC

Italy
arrow
KY/TN Water Professionals
Not Confirmed

Details : NTC and I-MED Pharma’s successful collaboration to bring I-DEFENSE® innovative ophthalmic ointment first to Canada and now to the U.S.A. is a testament to the dedication of both companies to advancing the science of dry eye.

Product Name : I-Defense

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

December 15, 2021

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Details:

Researchers at the National Institutes of Health and their collaborators found that inhaling unfragmented hyaluronan improves lung function in patients suffering from severe exacerbation of chronic obstructive pulmonary disease (COPD).


Lead Product(s): Sodium Hyaluronate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: HMW-HA

Study Phase: Phase IIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 02, 2021

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05

KY/TN Water Professionals
Not Confirmed
KY/TN Water Professionals
Not Confirmed

Details : Researchers at the National Institutes of Health and their collaborators found that inhaling unfragmented hyaluronan improves lung function in patients suffering from severe exacerbation of chronic obstructive pulmonary disease (COPD).

Product Name : HMW-HA

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

January 02, 2021

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Details:

LOA2 met its primary endpoint of non-inferiority vs. comparator at the 3-month time point in corneal staining with a p value of 0.001. LO2A continued, as in prior trials, to demonstrate a good safety profile with no major adverse events or side effects reported.


Lead Product(s): Sodium Hyaluronate

Therapeutic Area: Ophthalmology Brand Name: LO2A

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 11, 2020

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06

Wize Pharma

Israel
arrow
KY/TN Water Professionals
Not Confirmed

Wize Pharma

Israel
arrow
KY/TN Water Professionals
Not Confirmed

Details : LOA2 met its primary endpoint of non-inferiority vs. comparator at the 3-month time point in corneal staining with a p value of 0.001. LO2A continued, as in prior trials, to demonstrate a good safety profile with no major adverse events or side effects r...

Product Name : LO2A

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

December 11, 2020

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Details:

The clinical trial is designed to demonstrate the clinical efficacy and safety of LO2A in DES patients with Sjögren's syndrome. Phase IV study aims at expanding LO2A's current approved status.


Lead Product(s): Sodium Hyaluronate

Therapeutic Area: Ophthalmology Brand Name: LO2A

Study Phase: Phase IVProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 05, 2020

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07

Wize Pharma

Israel
arrow
KY/TN Water Professionals
Not Confirmed

Wize Pharma

Israel
arrow
KY/TN Water Professionals
Not Confirmed

Details : The clinical trial is designed to demonstrate the clinical efficacy and safety of LO2A in DES patients with Sjögren's syndrome. Phase IV study aims at expanding LO2A's current approved status.

Product Name : LO2A

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

July 05, 2020

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Details:

This agreement will advance Wize Pharma's ongoing clinical program for LO2A, currently in a Phase IV study for the treatment of dry eye syndrome in patients with Sjogren's.


Lead Product(s): Sodium Hyaluronate

Therapeutic Area: Ophthalmology Brand Name: LO2A

Study Phase: Phase IVProduct Type: Other Small Molecule

Sponsor: Bonus BioGroup

Deal Size: $7.4 million Upfront Cash: Undisclosed

Deal Type: Agreement January 16, 2020

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08

Wize Pharma

Israel
arrow
KY/TN Water Professionals
Not Confirmed

Wize Pharma

Israel
arrow
KY/TN Water Professionals
Not Confirmed

Details : This agreement will advance Wize Pharma's ongoing clinical program for LO2A, currently in a Phase IV study for the treatment of dry eye syndrome in patients with Sjogren's.

Product Name : LO2A

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

January 16, 2020

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FDF Dossiers

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01

Adcock Ingram

South Africa
KY/TN Water Professionals
Not Confirmed
arrow

Adcock Ingram

South Africa
arrow
KY/TN Water Professionals
Not Confirmed

Sodium hyaluronate

Brand Name : Healon

Dosage Form : INJ

Dosage Strength : 10mg/ml

Packaging : 0.55X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

AFT Pharmaceuticals

New Zealand
KY/TN Water Professionals
Not Confirmed
arrow

AFT Pharmaceuticals

New Zealand
arrow
KY/TN Water Professionals
Not Confirmed

hyaluronate sodium

Brand Name : Hylo-Fresh

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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03

Estilad

Canada
KY/TN Water Professionals
Not Confirmed
arrow

Estilad

Canada
arrow
KY/TN Water Professionals
Not Confirmed

Sodium DNA; Sodium Hyaluronate; Sodium Chloride; GLYCERIN; GLUCONOLACTONE; Sodium Benzoate; Calcium Gluconate

Brand Name :

Dosage Form : Solution

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Canada

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04

KY/TN Water Professionals
Not Confirmed
arrow
arrow
KY/TN Water Professionals
Not Confirmed

Sodium Hyaluronate

Brand Name : Afenemi

Dosage Form : Ophthalmic Solution

Dosage Strength : 1.8MG/ML

Packaging : Unit & Multi Dose Ophthalmic

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Vietnam

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05

KY/TN Water Professionals
Not Confirmed
arrow
arrow
KY/TN Water Professionals
Not Confirmed

Sodium Hyaluronate

Brand Name : Hyal Eyen Drops

Dosage Form : Eye Drop

Dosage Strength : 1MG

Packaging : Multi-Dose (10ml)

Approval Date :

Application Number :

Regulatory Info :

Registration Country : South Korea

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06

KY/TN Water Professionals
Not Confirmed
arrow
arrow
KY/TN Water Professionals
Not Confirmed

Sodium Hyaluronate

Brand Name :

Dosage Form : Eye Drops

Dosage Strength : 0.1%/W/V

Packaging : 10 ml Novellia Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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07

KY/TN Water Professionals
Not Confirmed
arrow
arrow
KY/TN Water Professionals
Not Confirmed

D-Panthenol; Aloe vera; Sodium Hyaluronate

Brand Name :

Dosage Form : Lotion

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Germany

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08

Unimed Pharm Inc.

South Korea
KY/TN Water Professionals
Not Confirmed
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Unimed Pharm Inc.

South Korea
arrow
KY/TN Water Professionals
Not Confirmed

Sodium Hyaluronate

Brand Name : Unilon Dispo

Dosage Form : INJECTION

Dosage Strength : 25MG/2.5ML

Packaging : Pre-Filled Syringe (PFS)

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Korea

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09

Unimed Pharm Inc.

South Korea
KY/TN Water Professionals
Not Confirmed
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Unimed Pharm Inc.

South Korea
arrow
KY/TN Water Professionals
Not Confirmed

Sodium Hyaluronate

Brand Name : Protade

Dosage Form : INJECTION

Dosage Strength : 1.1ML

Packaging : Pre-Filled Syringe (PFS)

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Korea

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10

Unimed Pharm Inc.

South Korea
KY/TN Water Professionals
Not Confirmed
arrow

Unimed Pharm Inc.

South Korea
arrow
KY/TN Water Professionals
Not Confirmed

Sodium Hyaluronate

Brand Name : Endo Ease

Dosage Form : INJECTION

Dosage Strength : 2ML

Packaging : Vials

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Korea

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Looking for / Sodium Hyaluronate API manufacturers, exporters & distributors?

Sodium Hyaluronate manufacturers, exporters & distributors 1

11

PharmaCompass offers a list of Sodium Hyaluronate 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 Sodium Hyaluronate manufacturer or Sodium Hyaluronate supplier for your needs.

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

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

API | Excipient name

Sodium Hyaluronate

Synonyms

Hyaluronic acid, sodium salt, Hyaluronic acid sodium, Kopuron, Healon, Hyalgan, Hyalurone sodium

About Sodium Hyaluronate

A natural high-viscosity mucopolysaccharide with alternating beta (1-3) glucuronide and beta (1-4) glucosaminidic bonds. It is found in the UMBILICAL CORD, in VITREOUS BODY and in SYNOVIAL FLUID. A high urinary level is found in PROGERIA.

EUFLEXXA injection Manufacturers

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

EUFLEXXA injection Suppliers

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

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

EUFLEXXA injection USDMF

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

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

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

EUFLEXXA injection JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The EUFLEXXA injection Drug Master File in Japan (EUFLEXXA injection JDMF) empowers EUFLEXXA injection API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the EUFLEXXA injection JDMF during the approval evaluation for pharmaceutical products. At the time of EUFLEXXA injection JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of EUFLEXXA injection suppliers with JDMF on PharmaCompass.

EUFLEXXA injection KDMF

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

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

After submitting a EUFLEXXA injection 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 EUFLEXXA injection API can apply through the Korea Drug Master File (KDMF).

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

EUFLEXXA injection CEP

A EUFLEXXA injection CEP of the European Pharmacopoeia monograph is often referred to as a EUFLEXXA injection Certificate of Suitability (COS). The purpose of a EUFLEXXA injection CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of EUFLEXXA injection EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of EUFLEXXA injection to their clients by showing that a EUFLEXXA injection CEP has been issued for it. The manufacturer submits a EUFLEXXA injection CEP (COS) as part of the market authorization procedure, and it takes on the role of a EUFLEXXA injection CEP holder for the record. Additionally, the data presented in the EUFLEXXA injection CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the EUFLEXXA injection DMF.

A EUFLEXXA injection CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. EUFLEXXA injection CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of EUFLEXXA injection suppliers with CEP (COS) on PharmaCompass.

EUFLEXXA injection WC

A EUFLEXXA injection written confirmation (EUFLEXXA injection WC) is an official document issued by a regulatory agency to a EUFLEXXA injection manufacturer, verifying that the manufacturing facility of a EUFLEXXA injection active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting EUFLEXXA injection APIs or EUFLEXXA injection finished pharmaceutical products to another nation, regulatory agencies frequently require a EUFLEXXA injection WC (written confirmation) as part of the regulatory process.

click here to find a list of EUFLEXXA injection suppliers with Written Confirmation (WC) on PharmaCompass.

EUFLEXXA injection 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 EUFLEXXA injection as an active pharmaceutical ingredient (API).

Finished drug products

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

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

EUFLEXXA injection GMP

EUFLEXXA injection 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 EUFLEXXA injection 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 EUFLEXXA injection GMP manufacturer or EUFLEXXA injection GMP API supplier for your needs.

EUFLEXXA injection CoA

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

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

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