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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 : 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.
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.
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, 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 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, Intrinsic Viscosity 1.4 M3/k...
Certificate Number : R1-CEP 2016-172 - Rev 00
Status : Valid
Issue Date : 2023-05-02
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 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, 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, 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.
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
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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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
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
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 : Other Small Molecule
Upfront Cash : Inapplicable
October 03, 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: Approved FDFProduct Type: Other 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 FDF
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 : Other Small Molecule
Upfront Cash : Undisclosed
April 15, 2024
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
Lead Product(s) : Sodium Hyaluronate,Triamcinolone Hexacetonide
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
January 11, 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: Approved FDFProduct Type: Other 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 FDF
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 : Other 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: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 02, 2021
Lead Product(s) : Sodium Hyaluronate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
January 02, 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: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 11, 2020
Lead Product(s) : Sodium Hyaluronate
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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
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
Lead Product(s) : Sodium Hyaluronate
Therapeutic Area : Ophthalmology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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
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
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 : LO2A
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
January 16, 2020
Regulatory Info : Generic
Registration Country : South Africa
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
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 : Canada
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
Regulatory Info :
Registration Country : Vietnam
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
Regulatory Info :
Registration Country : South Korea
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
Regulatory Info :
Registration Country : India
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
Regulatory Info :
Registration Country : Germany
D-Panthenol; Aloe vera; Sodium Hyaluronate
Brand Name :
Dosage Form : Lotion
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Germany
Regulatory Info : Generic
Registration Country : South Korea
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
Regulatory Info : Generic
Registration Country : South Korea
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
Regulatory Info : Generic
Registration Country : South Korea
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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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 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.
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.
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.
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.
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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).
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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.
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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.
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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 EUFLEXXA injection as an active pharmaceutical ingredient (API).
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.
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.
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.
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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.
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).