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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 : CEP 2018-107 - Rev 04
Issue Date : 2024-02-19
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 : CEP 2018-037 - Rev 03
Issue Date : 2025-03-26
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 : 2026-12-31
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 : R0-CEP 2022-269 - Rev 00
Issue Date : 2023-01-19
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 : 2023-02-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Bansen Co., Ltd.
Registration Date : 2025-01-15
Registration Number : 20250115-96-E-182-63
Manufacturer Name : Shandong Topscience Biotech Co., Ltd.
Manufacturer Address : No.98 Lanshan West Road, Lanshan District, Rizhao City, ShandongProvince, PR 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 : CEP 2021-220 - Rev 02
Issue Date : 2024-06-12
Type : Chemical
Substance Number : 1472
Status : Valid
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
Registrant Name : Hiple Co., Ltd.
Registration Date : 2022-07-08
Registration Number : 20130322-96-E-109-34(C)
Manufacturer Name : Bloomage Biotechnology Corp., Ltd.
Manufacturer Address : No 678, Tianchen St., High-Tech Development Zone, Jinan City, 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 : R1-CEP 2016-172 - Rev 00
Issue Date : 2023-05-02
Type : Chemical
Substance Number : 1472
Status : Valid
Registrant Name : Hiple Co., Ltd.
Registration Date : 2022-07-08
Registration Number : 20211021-96-E-171-54(A)
Manufacturer Name : Bloomage Biotechnology Corp., Ltd.
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.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26360
Submission : 2012-08-20
Status : Active
Type : II
Certificate Number : CEP 2010-290 - Rev 04
Issue Date : 2024-07-25
Type : Chemical
Substance Number : 1472
Status : Valid
Registrant Name : Unimed Pharmaceutical Co., Ltd.
Registration Date : 2022-03-23
Registration Number : 20130322-96-E-109-34(A)
Manufacturer Name : Bloomage Biotechnology Corp., LTD
Manufacturer Address : No. 678 Tianchen St., High-Tech Development Zone, Jian City, Shandong Province, PR of 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 : 35878
Submission : 2021-05-11
Status : Active
Type : II
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
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 : 38333
Submission : 2023-05-08
Status : Active
Type : II
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 : 27373
Submission : 2013-07-31
Status : Active
Type : II
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
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 : 38036
Submission : 2023-03-14
Status : Active
Type : II
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 : 35998
Submission : 2021-06-06
Status : Active
Type : II
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
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 : 35899
Submission : 2021-04-29
Status : Active
Type : II
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
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
Date of Issue : 2020-07-24
Valid Till : 2025-12-18
Written Confirmation Number : SD220043
Address of the Firm : No.678 Tianchen St., High-tech Development Zone, Jinan City, Shandong Province
Topscience Biotech specializes in R&D, production, and sales of Sodium Hyaluronate, focusing on Medical and Pharmaceutical Grade HA.
Date of Issue : 2022-12-06
Valid Till : 2025-12-18
Written Confirmation Number : SD220042
Address of the Firm : No 98, Lanshan West Road, Lanshan District, Rizhao City, Shandong Province-Post ...
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 : 2026-12-31
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 : 2026-12-31
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 : 2023-02-01
End Marketing Date : 2026-12-31
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 : 2026-12-31
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...
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
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Regulatory Info :
Registration Country : Italy
Sulfadiazine Silver; Sodium Hyaluronate
Brand Name : Connettivina Plus
Dosage Form :
Dosage Strength : 10 Gauzes 10 Cm X 10 Cm 2 Mg + 40 Mg
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 : 10 Gauzes 10 Cm X 20 Cm 4 Mg + 80 Mg
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
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 : Turkey
Brand Name :
Dosage Form :
Dosage Strength : 20MG/2ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Regulatory Info :
Registration Country : Switzerland
Brand Name : Lacri-Vision
Dosage Form : Eye Gel
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Lacri-Vision
Dosage Form : Eye Gel
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
Related Excipient Companies
Dosage Form : Tablet
Grade : Oral
Dosage Form : Cream / Lotion / Ointment
Grade : Topical, Parenteral
Excipients by Applications
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
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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 Hyaluronic acid, sodium salt manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hyaluronic acid, sodium salt, including repackagers and relabelers. The FDA regulates Hyaluronic acid, sodium salt manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hyaluronic acid, sodium salt 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 Hyaluronic acid, sodium salt manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hyaluronic acid, sodium salt supplier is an individual or a company that provides Hyaluronic acid, sodium salt active pharmaceutical ingredient (API) or Hyaluronic acid, sodium salt finished formulations upon request. The Hyaluronic acid, sodium salt suppliers may include Hyaluronic acid, sodium salt API manufacturers, exporters, distributors and traders.
click here to find a list of Hyaluronic acid, sodium salt suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hyaluronic acid, sodium salt DMF (Drug Master File) is a document detailing the whole manufacturing process of Hyaluronic acid, sodium salt active pharmaceutical ingredient (API) in detail. Different forms of Hyaluronic acid, sodium salt DMFs exist exist since differing nations have different regulations, such as Hyaluronic acid, sodium salt USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hyaluronic acid, sodium salt DMF submitted to regulatory agencies in the US is known as a USDMF. Hyaluronic acid, sodium salt USDMF includes data on Hyaluronic acid, sodium salt's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hyaluronic acid, sodium salt USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hyaluronic acid, sodium salt 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 Hyaluronic acid, sodium salt Drug Master File in Japan (Hyaluronic acid, sodium salt JDMF) empowers Hyaluronic acid, sodium salt 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 Hyaluronic acid, sodium salt JDMF during the approval evaluation for pharmaceutical products. At the time of Hyaluronic acid, sodium salt 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 Hyaluronic acid, sodium salt 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 Hyaluronic acid, sodium salt Drug Master File in Korea (Hyaluronic acid, sodium salt KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hyaluronic acid, sodium salt. The MFDS reviews the Hyaluronic acid, sodium salt KDMF as part of the drug registration process and uses the information provided in the Hyaluronic acid, sodium salt KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hyaluronic acid, sodium salt 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 Hyaluronic acid, sodium salt API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hyaluronic acid, sodium salt suppliers with KDMF on PharmaCompass.
A Hyaluronic acid, sodium salt CEP of the European Pharmacopoeia monograph is often referred to as a Hyaluronic acid, sodium salt Certificate of Suitability (COS). The purpose of a Hyaluronic acid, sodium salt CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hyaluronic acid, sodium salt EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hyaluronic acid, sodium salt to their clients by showing that a Hyaluronic acid, sodium salt CEP has been issued for it. The manufacturer submits a Hyaluronic acid, sodium salt CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hyaluronic acid, sodium salt CEP holder for the record. Additionally, the data presented in the Hyaluronic acid, sodium salt CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hyaluronic acid, sodium salt DMF.
A Hyaluronic acid, sodium salt CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hyaluronic acid, sodium salt CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Hyaluronic acid, sodium salt written confirmation (Hyaluronic acid, sodium salt WC) is an official document issued by a regulatory agency to a Hyaluronic acid, sodium salt manufacturer, verifying that the manufacturing facility of a Hyaluronic acid, sodium salt active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hyaluronic acid, sodium salt APIs or Hyaluronic acid, sodium salt finished pharmaceutical products to another nation, regulatory agencies frequently require a Hyaluronic acid, sodium salt WC (written confirmation) as part of the regulatory process.
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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 Hyaluronic acid, sodium salt as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hyaluronic acid, sodium salt 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 Hyaluronic acid, sodium salt 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 Hyaluronic acid, sodium salt and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hyaluronic acid, sodium salt NDC to their finished compounded human drug products, they may choose to do so.
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Hyaluronic acid, sodium salt 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 Hyaluronic acid, sodium salt 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 Hyaluronic acid, sodium salt GMP manufacturer or Hyaluronic acid, sodium salt GMP API supplier for your needs.
A Hyaluronic acid, sodium salt CoA (Certificate of Analysis) is a formal document that attests to Hyaluronic acid, sodium salt's compliance with Hyaluronic acid, sodium salt specifications and serves as a tool for batch-level quality control.
Hyaluronic acid, sodium salt CoA mostly includes findings from lab analyses of a specific batch. For each Hyaluronic acid, sodium salt 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.
Hyaluronic acid, sodium salt may be tested according to a variety of international standards, such as European Pharmacopoeia (Hyaluronic acid, sodium salt EP), Hyaluronic acid, sodium salt JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hyaluronic acid, sodium salt USP).