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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
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
Molecular Weight | 799.6 g/mol |
---|---|
Molecular Formula | C28H44N2NaO23+ |
Hydrogen Bond Donor Count | 14 |
Hydrogen Bond Acceptor Count | 23 |
Rotatable Bond Count | 12 |
Exact Mass | 799.22325494 g/mol |
Monoisotopic Mass | 799.22325494 g/mol |
Topological Polar Surface Area | 400 Ų |
Heavy Atom Count | 54 |
Formal Charge | 1 |
Complexity | 1300 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 20 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
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.)
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24507
Submission : 2010-12-20
Status : Active
Type : II
Certificate Number : R1-CEP 2015-201 - Rev 00
Issue Date : 2021-11-05
Type : Chemical
Substance Number : 1472
Status : Valid
Registration Number : 304MF10049
Registrant's Address : No. 678 Tianchen St. , High-Tech Development Zone, Jinan 250101 P. R. China
Initial Date of Registration : 2022-03-02
Latest Date of Registration :
Date of Issue : 2020-07-24
Valid Till : 2025-12-18
Written Confirmation Number : SD220043
Address of the Firm :
NDC Package Code : 67828-0000
Start Marketing Date : 2014-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Unimed Pharmaceutical Co., Ltd.
Registration Date : 2022-09-02
Registration Number : 20211021-96-E-171-54(2)
Manufacturer Name : Bloomage Biotechnology Corp., Ltd
Manufacturer Address : No 678, Tianchen St., High-Tech Development Zone, Jinan, Shandong province, China
Kewpie is your partner for Sodium Hyaluronate & Hyaluronic Acid// CEP, USDMF, KDMF & JDMF registered.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14727
Submission : 2000-02-29
Status : Active
Type : II
Certificate Number : R0-CEP 2019-064 - Rev 00
Issue Date : 2020-04-16
Type : Chemical and TSE
Substance Number : 1472
Status : Valid
Registration Number : 228MF10141
Registrant's Address : Shibuya 1-4-13, Shibuya-ku, Tokyo
Initial Date of Registration : 2016-08-02
Latest Date of Registration :
Registrant Name : Daeshin Pharmaceutical Co., Ltd.
Registration Date : 2023-06-22
Registration Number : 20071228-96-E-25-08(5)
Manufacturer Name : Kewpie Corporation Fine Chemical Division GOKA PLANT
Manufacturer Address : 1800, AZA-OOSAKI, OOAZA-KOTESASHI, GOKA-MACHI, SASHIMA-GUN, IBARAKI-KEN, 306-0315
Available Reg Filing : CN |
HTL Biotechnology is a French biotech & a global leader in the responsible development & production of pharma-grade biopolymers.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34855
Submission : 2020-10-08
Status : Active
Type : II
Certificate Number : CEP 2004-238 - Rev 06
Issue Date : 2024-07-19
Type : Chemical
Substance Number : 1472
Status : Valid
Registration Number : 228MF10072
Registrant's Address : 7 rue Alfred Kastler-ZI de l'Aumaillerie-35133 JAVENE-France
Initial Date of Registration : 2016-03-07
Latest Date of Registration :
NDC Package Code : 51035-001
Start Marketing Date : 2014-12-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Humedics Co., Ltd.
Registration Date : 2020-06-29
Registration Number : 20080530-96-E-69-18(2)
Manufacturer Name : HTL
Manufacturer Address : 7 Rue Alfred Kastler ZI De L'Aumaillerie 35133 JAVENE
Topscience Biotech specializes in R&D, production, and sales of Sodium Hyaluronate, focusing on Medical and Pharmaceutical Grade HA.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37918
Submission : 2023-05-05
Status : Active
Type : II
Certificate Number : R1-CEP 2013-349 - Rev 01
Issue Date : 2022-03-23
Type : Chemical
Substance Number : 1472
Status : Valid
Date of Issue : 2022-12-06
Valid Till : 2025-12-18
Written Confirmation Number : SD220042
Address of the Firm :
NDC Package Code : 84109-001
Start Marketing Date : 2024-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Bansen Co., Ltd.
Registration Date : 2024-10-23
Registration Number : 20241023-96-E-181-62
Manufacturer Name : Shandong Topscience Biotech Co., Ltd.
Manufacturer Address : No.98 Lanshan West Road, Lanshan District, Rizhao City, Shandong Province, China
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Registration Number : 219MF10034
Registrant's Address : 50 Binney Street, Cambridge, MA 02142, USA
Initial Date of Registration : 2007-02-05
Latest Date of Registration :
Registrant Name : Korea Alcon Co., Ltd.
Registration Date : 2008-05-07
Registration Number : 20080507-96-E-55-14
Manufacturer Name : Genzyme Corporation
Manufacturer Address : 76 New York Avenue, Framingham, MA 01701-9322
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24508
Submission : 2010-12-20
Status : Active
Type : II
Certificate Number : R1-CEP 2016-172 - Rev 00
Issue Date : 2023-05-02
Type : Chemical
Substance Number : 1472
Status : Valid
NDC Package Code : 67828-0000
Start Marketing Date : 2014-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Unimed Pharmaceutical Co., Ltd.
Registration Date : 2022-09-02
Registration Number : 20211021-96-E-171-54(2)
Manufacturer Name : Bloomage Biotechnology Corp., Ltd
Manufacturer Address : No 678, Tianchen St., High-Tech Development Zone, Jinan, Shandong province, China
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26039
Submission : 2012-05-07
Status : Active
Type : II
Certificate Number : CEP 2018-107 - Rev 04
Issue Date : 2024-02-19
Type : Chemical
Substance Number : 1472
Status : Valid
NDC Package Code : 67828-0000
Start Marketing Date : 2014-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Unimed Pharmaceutical Co., Ltd.
Registration Date : 2022-09-02
Registration Number : 20211021-96-E-171-54(2)
Manufacturer Name : Bloomage Biotechnology Corp., Ltd
Manufacturer Address : No 678, Tianchen St., High-Tech Development Zone, Jinan, Shandong province, China
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26360
Submission : 2012-08-20
Status : Active
Type : II
Certificate Number : CEP 2021-220 - Rev 02
Issue Date : 2024-06-12
Type : Chemical
Substance Number : 1472
Status : Valid
NDC Package Code : 67828-0000
Start Marketing Date : 2014-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Unimed Pharmaceutical Co., Ltd.
Registration Date : 2022-09-02
Registration Number : 20211021-96-E-171-54(2)
Manufacturer Name : Bloomage Biotechnology Corp., Ltd
Manufacturer Address : No 678, Tianchen St., High-Tech Development Zone, Jinan, Shandong province, China
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Sodium Hyaluronate, HA-EP 3.0 (intrinsic Viscosi...
Certificate Number : CEP 2010-290 - Rev 04
Status : Valid
Issue Date : 2024-07-25
Type : Chemical
Substance Number : 1472
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Sodium Hyaluronate, Intrinsic Viscosity 2.5 M3/k...
Certificate Number : CEP 2017-195 - Rev 01
Status : Valid
Issue Date : 2024-05-02
Type : Chemical
Substance Number : 1472
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Sodium Hyaluronate, Intrinsic Viscosity 3.8 M3/k...
Certificate Number : R0-CEP 2022-129 - Rev 01
Status : Valid
Issue Date : 2023-05-31
Type : Chemical
Substance Number : 1472
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Sodium Hyaluronate, Intrinsic Viscosity 1.8 M3/k...
Certificate Number : CEP 2021-220 - Rev 02
Status : Valid
Issue Date : 2024-06-12
Type : Chemical
Substance Number : 1472
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Sodium Hyaluronate, Intrinsic Viscosity 0.6 M3/k...
Certificate Number : R0-CEP 2021-446 - Rev 01
Status : Valid
Issue Date : 2023-06-15
Type : Chemical
Substance Number : 1472
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Sodium Hyaluronate, HA-EP 1.8 (intrinsic Viscosi...
Certificate Number : CEP 2010-289 - Rev 04
Status : Valid
Issue Date : 2023-09-15
Type : Chemical
Substance Number : 1472
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Sodium Hyaluronate, HA-E3.0 (intrinsic Viscosity...
Certificate Number : R1-CEP 2015-201 - Rev 00
Status : Valid
Issue Date : 2021-11-05
Type : Chemical
Substance Number : 1472
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Sodium Hyaluronate, Intrinsic Viscosity 2.4 M3/k...
Certificate Number : CEP 2018-107 - Rev 04
Status : Valid
Issue Date : 2024-02-19
Type : Chemical
Substance Number : 1472
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Sodium Hyaluronate, Intrinsic Viscosity 1.25 M3/...
Certificate Number : R0-CEP 2021-258 - Rev 02
Status : Valid
Issue Date : 2023-03-08
Type : Chemical
Substance Number : 1472
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Sodium Hyaluronate, HA-E2.0 (intrinsic Viscosity...
Certificate Number : CEP 2015-200 - Rev 01
Status : Valid
Issue Date : 2024-03-05
Type : Chemical
Substance Number : 1472
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Registrant Name : Unimed Pharmaceutical Co., Ltd.
Registration Date : 2022-03-23
Registration Number : 20130322-96-E-109-34(A)
Manufacturer Name : Bloomage Biotechnology Corp....
Manufacturer Address : No. 678 Tianchen St., High-Tech Development Zone, Jian City, Shandong Province, PR of...
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Registrant Name : Hiple Co., Ltd.
Registration Date : 2022-07-08
Registration Number : 20211021-96-E-171-54(A)
Manufacturer Name : Bloomage Biotechnology Corp....
Manufacturer Address : No. 678 Tianchen Street, High-Tech Development Zone, Jinan, China.
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Registrant Name : Hiple Co., Ltd.
Registration Date : 2022-07-08
Registration Number : 20130322-96-E-109-34(C)
Manufacturer Name : Bloomage Biotechnology Corp....
Manufacturer Address : No 678, Tianchen St., High-Tech Development Zone, Jinan City, Shandong Province, Chin...
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Registrant Name : Holy Land Ivy Farm
Registration Date : 2017-09-07
Registration Number : 20151016-96-E-123-38(5)
Manufacturer Name : Bloomage Freda Biopharm Co.,...
Manufacturer Address : No.678 Tianchen St., High-Tech Development Zone, Jinan City, Shangdong Province, Chin...
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2019-03-06
Registration Number : 20190306-96-E-150-45
Manufacturer Name : Bloomage Biotechnology Corp....
Manufacturer Address : No.678, Tianchen St., High-Tech Development Zone, Jinan, City, Shondong Province, PRo...
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Registrant Name : Korea BMI Co., Ltd.
Registration Date : 2017-09-01
Registration Number : 20130412-96-E-108-34(4)
Manufacturer Name : Bloomage Biotechnology Corp....
Manufacturer Address : No 678, Tianchen St., High-Tech Development Zone, Jinan City, Shandong Province, PR o...
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Registrant Name : MFC Corporation
Registration Date : 2021-10-21
Registration Number : 20211021-96-E-171-54
Manufacturer Name : Bloomage Biotechnology Corp....
Manufacturer Address : No. 678 Tianchen Street, High-Tech Development Zone, Jinan, China.
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Registrant Name : Sunhwain Global Co., Ltd.
Registration Date : 2016-08-29
Registration Number : 20130412-96-E-108-34(3)
Manufacturer Name : Bloomage Freda Biopharm Co.,...
Manufacturer Address : No.678 Tianchen St., High-Tech Development Zone, Jinan City, Shangdong Province, PR o...
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Registrant Name : MFC Corporation
Registration Date : 2019-11-11
Registration Number : 20130322-96-E-109-34(B)
Manufacturer Name : Bloomage Biotechnology Corp....
Manufacturer Address : No.678, Tianchen St., High-Tech Development Zone, Jinan, city, Shandong Province Chin...
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Registrant Name : IMCD Korea Co., Ltd.
Registration Date : 2017-12-08
Registration Number : 20151016-96-E-123-38(6)
Manufacturer Name : Bloomage Biotechnology Corp....
Manufacturer Address : No. 678 Tianchen St., High-Tech Development Zone, Jian City, Shandong Province, PR of...
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
NDC Package Code : 67828-0000
Start Marketing Date : 2014-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
NDC Package Code : 67828-0001
Start Marketing Date : 2014-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
HTL Biotechnology is a French biotech & a global leader in the responsible development & production of pharma-grade biopolymers.
NDC Package Code : 51035-002
Start Marketing Date : 2014-12-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
HTL Biotechnology is a French biotech & a global leader in the responsible development & production of pharma-grade biopolymers.
NDC Package Code : 51035-001
Start Marketing Date : 2014-12-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Topscience Biotech specializes in R&D, production, and sales of Sodium Hyaluronate, focusing on Medical and Pharmaceutical Grade HA.
NDC Package Code : 84109-001
Start Marketing Date : 2024-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 40004-001
Start Marketing Date : 2007-08-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 40004-002
Start Marketing Date : 2012-10-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 38779-2231
Start Marketing Date : 2017-04-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 38779-2860
Start Marketing Date : 2015-05-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 83428-001
Start Marketing Date : 2023-04-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
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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: ApprovedProduct Type: Small molecule
Sponsor: Lumenis
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 10, 2023
Lead Product(s) : Sodium Hyaluronate
Therapeutic Area : Trauma (Emergency, Injury, Surgery)
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Lumenis
Deal Size : Not Applicable
Deal Type : Not Applicable
Lumenis and Bloomage Biotech jointly released a new product - M22 medical wound dressing
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 : Small molecule
Upfront Cash : Not Applicable
March 10, 2023
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: ApprovedProduct Type: Small molecule
Sponsor: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement April 15, 2024
Lead Product(s) : Sodium Hyaluronate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Undisclosed
Deal Type : Licensing Agreement
BioSyent Announces Extension of RepaGyn® and Proktis-M® Agreement
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 : Small molecule
Upfront Cash : Undisclosed
April 15, 2024
Details:
The agreement aims to develop respirable, dry powder formulations of high molecular weight hyaluronan for treating or preventing respiratory diseases with a primary focus on COPD and viral respiratory diseases caused by SARS-CoV-2, influenza virus, and RSV.
Lead Product(s): Sodium Hyaluronate
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Large molecule
Sponsor: National Institute of Environmental Health Sciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 04, 2023
Lead Product(s) : Sodium Hyaluronate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : National Institute of Environmental Health Sciences
Deal Size : Undisclosed
Deal Type : Agreement
Details : The agreement aims to develop respirable, dry powder formulations of high molecular weight hyaluronan for treating or preventing respiratory diseases with a primary focus on COPD and viral respiratory diseases caused by SARS-CoV-2, influenza virus, and R...
Product Name : Undisclosed
Product Type : Large molecule
Upfront Cash : Undisclosed
May 04, 2023
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: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2022
Lead Product(s) : Sodium Hyaluronate,Triamcinolone Hexacetonide
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Anika’s Cingal® Successfully Achieves Primary Endpoint in Third Phase III Study
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 : Small molecule
Upfront Cash : Not Applicable
November 01, 2022
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: ApprovedProduct Type: Small molecule
Sponsor: I-MED
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership December 15, 2021
Lead Product(s) : Sodium Hyaluronate
Therapeutic Area : Ophthalmology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : I-MED
Deal Size : Undisclosed
Deal Type : Partnership
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 : Small molecule
Upfront Cash : Undisclosed
December 15, 2021
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: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2021
Lead Product(s) : Sodium Hyaluronate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
NIH Study Shows Hyaluronan is Effective in Treating Chronic Lung Disease
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 : Small molecule
Upfront Cash : Not Applicable
February 01, 2021
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: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 12, 2020
Lead Product(s) : Sodium Hyaluronate
Therapeutic Area : Ophthalmology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 : Small molecule
Upfront Cash : Not Applicable
November 12, 2020
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: Undisclosed
Study Phase: Phase IVProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 07, 2020
Lead Product(s) : Sodium Hyaluronate
Therapeutic Area : Ophthalmology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 : Undisclosed
Product Type : Small molecule
Upfront Cash : Not Applicable
May 07, 2020
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: Undisclosed
Study Phase: Phase IVProduct Type: Small molecule
Sponsor: Bonus BioGroup
Deal Size: $7.4 million Upfront Cash: Undisclosed
Deal Type: Agreement January 16, 2020
Lead Product(s) : Sodium Hyaluronate
Therapeutic Area : Ophthalmology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Bonus BioGroup
Deal Size : $7.4 million
Deal Type : Agreement
Wize Pharma Executes Agreements for Strategic Transaction with Bonus BioGroup
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 : Undisclosed
Product Type : Small molecule
Upfront Cash : Undisclosed
January 16, 2020
Regulatory Info :
Registration Country : Italy
Sulfadiazine Silver; Sodium Hyaluronate
Brand Name : Connettivina Plus
Dosage Form :
Dosage Strength : Cream Derm 25 G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Sulfadiazine Silver; Sodium Hyaluronate
Brand Name : Connettivina Plus
Dosage Form :
Dosage Strength : 5 Gauze 20 Cm X 30 Cm 12 Mg + 240 Mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Switzerland
Brand Name : Ialugen Creme
Dosage Form : Creme
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Ialugen Creme
Dosage Form : Creme
Dosage Strength :
Packaging :
Approval Date :
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Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Ialugen Creme
Dosage Form : Creme
Dosage Strength :
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Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Sodium hyaluronate; Sulfadiazinum argenticum
Brand Name : Ialugen Plus Cream
Dosage Form : Cream
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Sodium hyaluronate; Sulfadiazinum argenticum
Brand Name : Ialugen Plus Cream
Dosage Form : Cream
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Sweden
Brand Name : Hyalgan
Dosage Form : INJEKTIONSVÄTSKA, LÖSNING
Dosage Strength : 10 MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info : Generic
Registration Country : Turkey
Brand Name :
Dosage Form : EYE DROPS
Dosage Strength : 0.15%
Packaging : 5 Ml/Bottle
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey
Regulatory Info :
Registration Country : Sweden
Brand Name : Artzal
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 10 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
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Website
Corporate PDF
Regulatory Info :
Registration Country : Canada
Brand Name : LEGEND
Dosage Form : SOLUTION
Dosage Strength : 10MG/ML
Packaging : 2ML/4ML
Approval Date :
Application Number : 2169541
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : HY-50
Dosage Form : SOLUTION
Dosage Strength : 17MG/ML
Packaging : 3ML
Approval Date :
Application Number : 2238566
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : NEXHA
Dosage Form : SOLUTION
Dosage Strength : 10MG/ML
Packaging : 2ML-IA/4ML-IV
Approval Date :
Application Number : 2375176
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Australia
Brand Name : Hylo-Fresh
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Hylo-Forte
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Hylo-Forte
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Hylo-Fresh
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Hylo-Fresh
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Hylo-Forte
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Related Excipient Companies
Excipients by Applications
Dosage Form : Cream / Lotion / Ointment, Injectable / Parenteral
Grade : Topical, Parenteral
Category : Parenteral, Topical
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Tablet
Grade : Parenteral, Oral, Topical
Category : Parenteral, Solubilizers, Topical
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Solution, Tablet
Grade : Parenteral, Oral, Topical
Category : Emulsifying Agents, Parenteral, Solubilizers, Surfactant & Foaming Agents, Topical
Brand Name : Polyoxyethylene (35) Castor Oil
Application : Emulsifying Agents, Parenteral, Solubilizers, Surfactant & Foaming Agents, Topical
Excipient Details : Polyxyl 35 castor oil is used as surfactant & emulsifier in parenteral formulations. It acts as solubilizer & emulsifier in oral & topical products.
Dosage Form : Cream / Lotion / Ointment, Emulsion, Injectable / Parenteral, Softgels, Tablet
Grade : Oral, Topical, Parenteral
Category : Film Formers & Plasticizers, Parenteral, Topical
Dosage Form : Tablet, Injectable / Parenteral
Grade : Not Available
Category : API Stability Enhancers, Solubilizers
Brand Name : Polyoxyethylene (35) Castor Oil
Application : API Stability Enhancers, Solubilizers
Excipient Details : It is used as solubilizers for paclitaxel, cyclosporine, vitamin K1.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Polyoxyl 35 Castor Oil
Dosage Form : Emulsion, Injectable / Parenteral, Solution, Suspension
Grade : Not Available
Category : Emulsifying Agents, Parenteral, Solubilizers
Application : Emulsifying Agents, Parenteral, Solubilizers
Excipient Details : Solubilizer, Dissolution Improver, Emulsifier, Masking Agent, Moisturizer, Aerosol Formulations
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Polyoxyl 35 Hydrogenated Castor Oil
Dosage Form : Cream / Lotion / Ointment, Injectable / Parenteral
Grade : Parenteral and Topical
Category : Parenteral, Topical
Application : Parenteral, Topical
Brand Name : Sodium Chloride USP
Application : Parenteral
Excipient Details : A & C's Sodium Chloride is an excipient meeting the USP monograph.
Brand Name : Glycerol Multi-Compendial
Application : Parenteral
Excipient Details : A & C's Glycerol multi-compendial is an excipient that meets USP-NF, EP and BP monographs.
Pharmacopoeia Ref : Multi-compendial
Technical Specs : Not Available
Ingredient(s) : Glycerol Excipient
Application : Parenteral
Excipient Details : A & C's Glycerol is an excipient which meets the USP monograph.
Grade : Not Available
Category : Co-Processed Excipients, Fillers, Diluents & Binders
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : It is a Co-Processed Lactose starch for filler/binder having strong disintegrant properties.
Global Sales Information
Silver Sulfadiazine; Sodium Hyaluronate
Dosage Form :
Dosage Strength : Cream Derm 25 G
Price Per Pack (Euro) : 9.65
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Silver Sulfadiazine; Sodium Hyaluronate
Dosage Form :
Dosage Strength : 10 Gauzes 10 Cm X 10 Cm 2 Mg + 40 Mg
Price Per Pack (Euro) : 10.7
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Silver Sulfadiazine; Sodium Hyaluronate
Dosage Form :
Dosage Strength : 10 Gauzes 10 Cm X 20 Cm 4 Mg + 80 Mg
Price Per Pack (Euro) : 14.2
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Silver Sulfadiazine; Sodium Hyaluronate
Dosage Form :
Dosage Strength : 5 Gauze 20 Cm X 30 Cm 12 Mg + 240 Mg
Price Per Pack (Euro) : 17.38
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Sodium Hyaluronate; Sulfadiazine
Dosage Form : Cream
Dosage Strength :
Price Per Pack (Euro) : 6.55
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Sodium Hyaluronate; Sulfadiazine
Dosage Form : Cream
Dosage Strength :
Price Per Pack (Euro) : 12.9
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Sodium Hyaluronate; Sulfadiazine
Dosage Form : Cream
Dosage Strength :
Price Per Pack (Euro) : 76.3
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Dosage Form : Creme
Dosage Strength :
Price Per Pack (Euro) : 10.98
Published in :
Country : Switzerland
RX/OTC/DISCN : Class D
Dosage Form : Creme
Dosage Strength :
Price Per Pack (Euro) : 21.9
Published in :
Country : Switzerland
RX/OTC/DISCN : Class D
IBSA FARMACEUTICI ITALIA Srl
Silver Sulfadiazine; Sodium Hyaluronate
Dosage Form :
Dosage Strength : Cream Derm 25 G
Price Per Pack (Euro) : 9.3
Published in :
Country : Italy
RX/OTC/DISCN : Class C
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Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
68
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.
A Sodium Hyaluronate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Hyaluronate, including repackagers and relabelers. The FDA regulates Sodium Hyaluronate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Hyaluronate 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 Sodium Hyaluronate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Hyaluronate supplier is an individual or a company that provides Sodium Hyaluronate active pharmaceutical ingredient (API) or Sodium Hyaluronate finished formulations upon request. The Sodium Hyaluronate suppliers may include Sodium Hyaluronate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Hyaluronate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Hyaluronate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Hyaluronate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Hyaluronate DMFs exist exist since differing nations have different regulations, such as Sodium Hyaluronate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Hyaluronate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Hyaluronate USDMF includes data on Sodium Hyaluronate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Hyaluronate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Hyaluronate suppliers with USDMF on PharmaCompass.
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 Sodium Hyaluronate Drug Master File in Japan (Sodium Hyaluronate JDMF) empowers Sodium Hyaluronate 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 Sodium Hyaluronate JDMF during the approval evaluation for pharmaceutical products. At the time of Sodium Hyaluronate 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 Sodium Hyaluronate suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Sodium Hyaluronate Drug Master File in Korea (Sodium Hyaluronate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sodium Hyaluronate. The MFDS reviews the Sodium Hyaluronate KDMF as part of the drug registration process and uses the information provided in the Sodium Hyaluronate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sodium Hyaluronate 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 Sodium Hyaluronate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sodium Hyaluronate suppliers with KDMF on PharmaCompass.
A Sodium Hyaluronate CEP of the European Pharmacopoeia monograph is often referred to as a Sodium Hyaluronate Certificate of Suitability (COS). The purpose of a Sodium Hyaluronate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sodium Hyaluronate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sodium Hyaluronate to their clients by showing that a Sodium Hyaluronate CEP has been issued for it. The manufacturer submits a Sodium Hyaluronate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sodium Hyaluronate CEP holder for the record. Additionally, the data presented in the Sodium Hyaluronate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sodium Hyaluronate DMF.
A Sodium Hyaluronate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sodium Hyaluronate 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 Sodium Hyaluronate suppliers with CEP (COS) on PharmaCompass.
A Sodium Hyaluronate written confirmation (Sodium Hyaluronate WC) is an official document issued by a regulatory agency to a Sodium Hyaluronate manufacturer, verifying that the manufacturing facility of a Sodium Hyaluronate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sodium Hyaluronate APIs or Sodium Hyaluronate finished pharmaceutical products to another nation, regulatory agencies frequently require a Sodium Hyaluronate WC (written confirmation) as part of the regulatory process.
click here to find a list of Sodium Hyaluronate suppliers with Written Confirmation (WC) on PharmaCompass.
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 Sodium Hyaluronate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sodium Hyaluronate API and other APIs are published in this directory by the FDA.
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 Sodium Hyaluronate 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.
The NDC directory also contains data on finished compounded human drug products that contain Sodium Hyaluronate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sodium Hyaluronate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sodium Hyaluronate suppliers with NDC on PharmaCompass.
Sodium Hyaluronate 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 Sodium Hyaluronate 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 Sodium Hyaluronate GMP manufacturer or Sodium Hyaluronate GMP API supplier for your needs.
A Sodium Hyaluronate CoA (Certificate of Analysis) is a formal document that attests to Sodium Hyaluronate's compliance with Sodium Hyaluronate specifications and serves as a tool for batch-level quality control.
Sodium Hyaluronate CoA mostly includes findings from lab analyses of a specific batch. For each Sodium Hyaluronate 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.
Sodium Hyaluronate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium Hyaluronate EP), Sodium Hyaluronate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium Hyaluronate USP).