Synopsis
Synopsis
0
EU WC
0
KDMF
0
VMF
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
Annual Reports
NA
1. Deferoxamine
2. Deferoxamine B
3. Deferoxamine Mesilate
4. Deferoxamine Methanesulfonate
5. Deferoximine
6. Deferrioxamine B
7. Desferal
8. Desferioximine
9. Desferrioxamine
10. Desferrioxamine B
11. Desferrioxamine B Mesylate
12. Desferroxamine
13. Mesilate, Deferoxamine
14. Mesylate, Deferoxamine
15. Mesylate, Desferrioxamine B
16. Methanesulfonate, Deferoxamine
1. 138-14-7
2. Desferal
3. Desferrioxamine B Mesylate
4. Deferoxamine Mesilate
5. Desferrioxamine Mesylate
6. Deferoxamine Methanesulfonate
7. Deferoxamine B Mesylate
8. Deferoxamine (mesylate)
9. Desferal Mesylate
10. Desferrioxamine Mesilate
11. V9tko7eo6k
12. Nsc-756718
13. Mls000028713
14. Desferrioxamine B Mesylate;dfom
15. Ba-33112
16. N-(5-(3-((5-aminopentyl)hydroxycarbamoyl)propionamido)pentyl)-3-((5-(n-hydroxyacetamido)pentyl)carbamoyl)propionohydroxamic Acid Monomethanesulfonate (salt)
17. Ncgc00017021-01
18. Cas-138-14-7
19. Deferoxaminemesylate
20. Desferal (tn)
21. Deferoxamine-d8 Mesylate
22. Deferoxamine Mesylate Salt
23. Dsstox_cid_17649
24. Dsstox_rid_79351
25. Dsstox_gsid_37649
26. N-[5-[[4-[5-[acetyl(hydroxy)amino]pentylamino]-4-oxobutanoyl]-hydroxyamino]pentyl]-n'-(5-aminopentyl)-n'-hydroxybutanediamide;methanesulfonic Acid
27. Desferal Methanesulfonate
28. Chebi:31460
29. Deferoxamine Mesylate [usan]
30. Nsc644468
31. Desferioxamine Mesylate
32. Sr-01000695424
33. Smr000058548
34. Einecs 205-314-3
35. Unii-v9tko7eo6k
36. Ba 33122
37. 138d147
38. Ccris 8311
39. Deferoxamine Mesylate [usan:usp]
40. Deferoxamini Mesilas
41. Prestwick_988
42. Mfcd00058605
43. Chembl1234
44. Deferoxamine Mesylate (usp)
45. Schembl119982
46. Spectrum1500224
47. Deferoxamine Mesilate (jp17)
48. Dtxsid6037649
49. Hms500e04
50. Hms1570a12
51. Hms1920c16
52. Hms2091k08
53. Hms2097a12
54. Hms2234h23
55. Hms3714a12
56. Pharmakon1600-01500224
57. Deferoxamine Mesilate [jan]
58. Bcp31290
59. Ex-a4085
60. Hy-b0988
61. Tox21_110741
62. Ccg-39770
63. Deferoxamine Mesylate [vandf]
64. Nsc756718
65. S5742
66. Akos026750165
67. Deferoxamine Mesilate [who-dd]
68. Deferoxamine Mesilate [who-ip]
69. Deferoxamine Mesylate [usp-rs]
70. Tox21_110741_1
71. Cs-4479
72. Nsc 756718
73. Nsc-644468
74. Desferrioxamine Mesilate [mart.]
75. Desferrioxamine Mesylate [who-ip]
76. Ncgc00017021-02
77. Ncgc00017021-03
78. Ncgc00094640-01
79. Ncgc00094640-02
80. Ncgc00178802-06
81. Ac-36517
82. Butanediamide, N'-(5-((4-((5-(acetylhydroxyamino)pentyl)amino)-1,4-dioxobutyl)hydroxyamino)pentyl)-n-(5-aminopentyl)-n-hydroxy-, Monomethanesulfonate
83. Deferoxamine Mesylate - Cas 138-14-7
84. Deferoxamine Methanesulfonate [mi]
85. Propionohydroxamic Acid, N-(5-(3-((5-aminopentyl)hydroxycarbamoyl)propionamido)pentyl)-3-((5-(n-hydroxyacetamido)pentyl)carbamoyl)-, Monomethanesulfonate (salt)
86. Deferoxamine Mesylate [orange Book]
87. Db-042415
88. Deferoxamine Mesilate [ep Monograph]
89. Deferoxamini Mesilas [who-ip Latin]
90. Deferoxamine Mesylate [usp Monograph]
91. Ft-0603121
92. D01186
93. A807339
94. Sr-01000695424-2
95. Sr-01000695424-3
96. Sr-01000695424-4
97. Deferoxamine Mesylate Salt, Powder, >=92.5% (tlc)
98. Q27114315
99. Desferrioxamine B Mesylate; Dfom;desferrioxamine Mesylate
100. Deferoxamine Mesylate Salt, European Pharmacopoeia (ep) Reference Standard
101. Deferoxamine Mesylate, United States Pharmacopeia (usp) Reference Standard
102. Deferoxamine For System Suitability, European Pharmacopoeia (ep) Reference Standard
103. Butanediamide, N'(-(((((acetylhydroxyamino)pentyl)mino)1,4-dioxobutyl)ydroxyamino)entyl)n-(5-aminopentyl)-n-hydroxy-, Monomethanesulfonate
104. Butanediamide, N'(-(((((acetylhydroxyamino)pentyl)mino)1,4-dioxobutyl)ydroxyamino)entyl)n-(5-aminopentyl)-n-hydroxy-, Monomethanesulphonate
105. N'-(5-azanylpentyl)-n-[5-[[4-[5-[ethanoyl(oxidanyl)amino]pentylamino]-4-oxidanylidene-butanoyl]-oxidanyl-amino]pentyl]-n'-oxidanyl-butanediamide; Methanesulfonic Acid
106. N'-{5-[acetyl(hydroxy)amino]pentyl}-n-[5-({4-[(5-aminopentyl)(hydroxy)amino]-4-oxobutanoyl}amino)pentyl]-n-hydroxysuccinamide Methanesulfonate (salt)
107. N-(5-(3-((5-aminopentyl)hydroxycarbamoyl)propionamido)pentyl)-3-((5-(n-hydroxyacetamido)pentyl)carbamoyl)propionohydroxamic Acid Monomethanesulphonate (salt)
108. N-[5-[[4-[5-[acetyl(hydroxy)amino]pentylamino]-1,4-dioxobutyl]-hydroxyamino]pentyl]-n'-(5-aminopentyl)-n'-hydroxybutanediamide; Methanesulfonic Acid
109. N1-(5-(4-((5-aminopentyl)amino)-4-oxobutanamido)pentyl)-n1-hydroxy-n4-(5-(n-hydroxyacetamido)pentyl)succinamide Methanesulfonate
110. N1-(5-aminopentyl)-n1-hydroxy-n4-(5-(n-hydroxy-4-(5-(n-hydroxyacetamido)pentylamino)-4-oxobutanamido)pentyl)succinamide Methanesulfonate
111. N4-[5-[[4-[[5-(acetylhydroxyamino)pentyl]amino-1,4-dioxobutyl]hydroxyamino]pentyl]-n1-(5-aminopentyl)-n1-hydroxybutanediamide Methanesulfonate
Molecular Weight | 656.8 g/mol |
---|---|
Molecular Formula | C26H52N6O11S |
Hydrogen Bond Donor Count | 7 |
Hydrogen Bond Acceptor Count | 12 |
Rotatable Bond Count | 23 |
Exact Mass | 656.34147767 g/mol |
Monoisotopic Mass | 656.34147767 g/mol |
Topological Polar Surface Area | 269 Ų |
Heavy Atom Count | 44 |
Formal Charge | 0 |
Complexity | 832 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 4 | |
---|---|
Drug Name | Deferoxamine mesylate |
Drug Label | Deferoxamine mesylate for injection, USP, is an iron-chelating agent, available in vials for intramuscular, subcutaneous, and intravenous administration. Deferoxamine mesylate is supplied as vials containing 500 mg and 2 g of deferoxamine mesylate US... |
Active Ingredient | Deferoxamine mesylate |
Dosage Form | Injectable |
Route | Injection |
Strength | 500mg/vial; 2gm/vial |
Market Status | Prescription |
Company | Fresenius Kabi Usa; Hospira; Eurohlth Intl |
2 of 4 | |
---|---|
Drug Name | Desferal |
PubMed Health | Deferoxamine (Injection) |
Drug Classes | Heavy Metal Chelator |
Drug Label | Desferal, deferoxamine mesylate USP, is an iron-chelating agent, available in vials for intramuscular, subcutaneous, and intravenous administration. Desferal is supplied as vials containing 500 mg and 2 g of deferoxamine mesylate USP in sterile, lyop... |
Active Ingredient | Deferoxamine mesylate |
Dosage Form | Injectable |
Route | Injection |
Strength | 500mg/vial; 2gm/vial |
Market Status | Prescription |
Company | Novartis |
3 of 4 | |
---|---|
Drug Name | Deferoxamine mesylate |
Drug Label | Deferoxamine mesylate for injection, USP, is an iron-chelating agent, available in vials for intramuscular, subcutaneous, and intravenous administration. Deferoxamine mesylate is supplied as vials containing 500 mg and 2 g of deferoxamine mesylate US... |
Active Ingredient | Deferoxamine mesylate |
Dosage Form | Injectable |
Route | Injection |
Strength | 500mg/vial; 2gm/vial |
Market Status | Prescription |
Company | Fresenius Kabi Usa; Hospira; Eurohlth Intl |
4 of 4 | |
---|---|
Drug Name | Desferal |
PubMed Health | Deferoxamine (Injection) |
Drug Classes | Heavy Metal Chelator |
Drug Label | Desferal, deferoxamine mesylate USP, is an iron-chelating agent, available in vials for intramuscular, subcutaneous, and intravenous administration. Desferal is supplied as vials containing 500 mg and 2 g of deferoxamine mesylate USP in sterile, lyop... |
Active Ingredient | Deferoxamine mesylate |
Dosage Form | Injectable |
Route | Injection |
Strength | 500mg/vial; 2gm/vial |
Market Status | Prescription |
Company | Novartis |
Siderophores
Low-molecular-weight compounds produced by microorganisms that aid in the transport and sequestration of ferric iron. (The Encyclopedia of Molecular Biology, 1994) (See all compounds classified as Siderophores.)
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12241
Submission : 1996-12-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-25
Pay. Date : 2013-01-15
DMF Number : 25421
Submission : 2012-03-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18459
Submission : 2005-06-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19052
Submission : 2005-12-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16653
Submission : 2003-06-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10041
Submission : 1993-01-13
Status : Inactive
Type : II
Deferoxamine Mesilate, Produced By Fermentation
Certificate Number : R1-CEP 2000-160 - Rev 04
Status : Valid
Issue Date : 2022-06-17
Type : Chemical
Substance Number : 896
Deferoxamine Mesilate, Produced By A Synthetic P...
Certificate Number : CEP 2009-401 - Rev 05
Status : Valid
Issue Date : 2024-10-25
Type : Chemical
Substance Number : 896
Registration Number : 223MF10158
Registrant's Address : NUERNBERGER STRASSE 12, 90537 FEUCHT, GERMANY
Initial Date of Registration : 2011-11-14
Latest Date of Registration : 2011-11-14
NDC Package Code : 46014-1127
Start Marketing Date : 2017-10-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 46014-1003
Start Marketing Date : 2005-09-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 17337-0060
Start Marketing Date : 2015-01-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 51846-1016
Start Marketing Date : 2022-01-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 84671-1016
Start Marketing Date : 2022-01-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
About the Company : Fareva’s API division has special technologies for high potent APIs (HPAPIs) down to the OEB-6 level, aseptic crystallization (sterile APIs), Spray Drying etc, with volumes rangi...
About the Company : We produce Active Pharmaceutical Ingredients (APIs) providing integrated full-service capabilities. Olon’s ability to develop and manufacture Active Pharmaceutical Ingredients (...
About the Company : Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and...
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
Upgrade, download data, analyse, strategize, subscribe with us
Details:
Mitem acquires Desfera (deferoxamine mesylate) products from Novartis. It is indicated for treating iron overload, and forex, following blood transfusions necessary for treating beta-thalassemia.
Lead Product(s): Deferoxamine Mesylate
Therapeutic Area: Pharmacology/Toxicology Brand Name: Desfera
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Mitem Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition September 25, 2024
Lead Product(s) : Deferoxamine Mesylate
Therapeutic Area : Pharmacology/Toxicology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Mitem Pharma
Deal Size : Undisclosed
Deal Type : Acquisition
MITEM Pharma Acquires DESFERAL® Rights Backed by TECHLIFE CAPITAL, MACSF
Details : Mitem acquires Desfera (deferoxamine mesylate) products from Novartis. It is indicated for treating iron overload, and forex, following blood transfusions necessary for treating beta-thalassemia.
Brand Name : Desfera
Molecule Type : Small molecule
Upfront Cash : Undisclosed
September 25, 2024
Details:
The trial will investigate the company’s Deferoxamine Intradermal Drug Patch (DIDP), for the topical treatment of Sickle Cell Leg Ulcers (SCUs) in support of its Orphan Drug Designation awarded in March of 2019.
Lead Product(s): Deferoxamine Mesylate
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2020
Lead Product(s) : Deferoxamine Mesylate
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Theris Medical Launches Patient Enrollment for “Orphan Drug” Clinical Trial to Help African-Am...
Details : The trial will investigate the company’s Deferoxamine Intradermal Drug Patch (DIDP), for the topical treatment of Sickle Cell Leg Ulcers (SCUs) in support of its Orphan Drug Designation awarded in March of 2019.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 15, 2020
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code :
Brand Name : DEFEROXAMINE MESYLATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 500MG/VIAL
Approval Date : 2006-03-31
Application Number : 76806
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code :
Brand Name : DEFEROXAMINE MESYLATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 2GM/VIAL
Approval Date : 2006-03-31
Application Number : 76806
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AP
Brand Name : DEFEROXAMINE MESYLATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 500MG/VIAL
Approval Date : 2009-09-15
Application Number : 78718
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : DEFEROXAMINE MESYLATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 2GM/VIAL
Approval Date : 2009-09-15
Application Number : 78718
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : DEFEROXAMINE MESYLATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 500MG/VIAL
Approval Date : 2017-09-29
Application Number : 207384
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : DEFEROXAMINE MESYLATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 2GM/VIAL
Approval Date : 2017-09-29
Application Number : 207384
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : DEFEROXAMINE MESYLATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 500MG/VIAL
Approval Date : 2004-03-17
Application Number : 76019
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : DEFEROXAMINE MESYLATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 2GM/VIAL
Approval Date : 2004-03-17
Application Number : 76019
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : DESFERAL
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 500MG/VIAL
Approval Date : 1982-01-01
Application Number : 16267
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : Yes
TE Code :
Brand Name : DESFERAL
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2000-05-25
Application Number : 16267
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
Regulatory Info :
Registration Country : Switzerland
Brand Name : Desferal
Dosage Form : Dry Sub
Dosage Strength : 500mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Available Dossier- US-EU-RoW
Registration Country : Italy
Brand Name :
Dosage Form : Lyophilizate
Dosage Strength : 500MG
Packaging : Vial
Approval Date :
Application Number :
Regulatory Info : Available Dossier- US-EU-RoW
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name :
Dosage Form : Lyophilizate
Dosage Strength : 2000MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Sweden
Brand Name : Desferin
Dosage Form : POWDER FOR INJECTION / INFUSION
Dosage Strength : 500 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Desferal
Dosage Form : POWDER FOR INJECTION / INFUSION
Dosage Strength : 500 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Desferal
Dosage Form : Powder for injection/infusion fluid, resolution
Dosage Strength : 500 mg
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Sweden
Brand Name : Desferal
Dosage Form : POWDER FOR INJECTION / INFUSION
Dosage Strength : 500 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Desferal
Dosage Form : POWDER FOR INJECTION / INFUSION
Dosage Strength : 500 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Desferal
Dosage Form : POWDER FOR INJECTION / INFUSION
Dosage Strength : 500 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Norway
Brand Name : Desferal
Dosage Form : Powder for injection/infusion fluid, resolution
Dosage Strength : 500 mg
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Global Sales Information
Dosage Form : Dry Sub
Dosage Strength : 500mg
Price Per Pack (Euro) : 55.58
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Dosage Form : Powder And Solvent For Injection
Dosage Strength : 500 mg/5 ml
Price Per Pack (Euro) : 43.59
Published in :
Country : Italy
RX/OTC/DISCN :
Dosage Form : Powder for injection/infusion fl...
Dosage Strength : 500 mg
Price Per Pack (Euro) : 58.586
Published in :
Country : Norway
RX/OTC/DISCN :
2care4
Dosage Form : Powder for injection/infusion fl...
Dosage Strength : 500 mg
Price Per Pack (Euro) : 58.586
Published in :
Country : Norway
RX/OTC/DISCN :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
NORIDEM ENTERPRISES LTD
Dosage Form : Powder For Solution For Injectio...
Dosage Strength : 500 mg
Price Per Pack (Euro) : 43.53
Published in :
Country : Italy
RX/OTC/DISCN :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Market Place
Reply
03 Feb 2024
Reply
02 Mar 2023
Reply
16 Dec 2022
Reply
29 Apr 2022
Reply
16 Sep 2021
Reply
18 Mar 2021
Reply
13 Mar 2021
Reply
09 Mar 2021
Reply
19 Nov 2020
Reply
13 Oct 2021
Reply
14 Aug 2020
Reply
24 Sep 2019
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Deferoxamine Mesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Deferoxamine Mesylate, including repackagers and relabelers. The FDA regulates Deferoxamine Mesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Deferoxamine Mesylate 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 Deferoxamine Mesylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Deferoxamine Mesylate supplier is an individual or a company that provides Deferoxamine Mesylate active pharmaceutical ingredient (API) or Deferoxamine Mesylate finished formulations upon request. The Deferoxamine Mesylate suppliers may include Deferoxamine Mesylate API manufacturers, exporters, distributors and traders.
click here to find a list of Deferoxamine Mesylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Deferoxamine Mesylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Deferoxamine Mesylate active pharmaceutical ingredient (API) in detail. Different forms of Deferoxamine Mesylate DMFs exist exist since differing nations have different regulations, such as Deferoxamine Mesylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Deferoxamine Mesylate DMF submitted to regulatory agencies in the US is known as a USDMF. Deferoxamine Mesylate USDMF includes data on Deferoxamine Mesylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Deferoxamine Mesylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Deferoxamine Mesylate 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 Deferoxamine Mesylate Drug Master File in Japan (Deferoxamine Mesylate JDMF) empowers Deferoxamine Mesylate 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 Deferoxamine Mesylate JDMF during the approval evaluation for pharmaceutical products. At the time of Deferoxamine Mesylate 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 Deferoxamine Mesylate suppliers with JDMF on PharmaCompass.
A Deferoxamine Mesylate CEP of the European Pharmacopoeia monograph is often referred to as a Deferoxamine Mesylate Certificate of Suitability (COS). The purpose of a Deferoxamine Mesylate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Deferoxamine Mesylate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Deferoxamine Mesylate to their clients by showing that a Deferoxamine Mesylate CEP has been issued for it. The manufacturer submits a Deferoxamine Mesylate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Deferoxamine Mesylate CEP holder for the record. Additionally, the data presented in the Deferoxamine Mesylate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Deferoxamine Mesylate DMF.
A Deferoxamine Mesylate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Deferoxamine Mesylate 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 Deferoxamine Mesylate suppliers with CEP (COS) 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 Deferoxamine Mesylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Deferoxamine Mesylate 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 Deferoxamine Mesylate 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 Deferoxamine Mesylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Deferoxamine Mesylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Deferoxamine Mesylate suppliers with NDC on PharmaCompass.
Deferoxamine Mesylate 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 Deferoxamine Mesylate 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 Deferoxamine Mesylate GMP manufacturer or Deferoxamine Mesylate GMP API supplier for your needs.
A Deferoxamine Mesylate CoA (Certificate of Analysis) is a formal document that attests to Deferoxamine Mesylate's compliance with Deferoxamine Mesylate specifications and serves as a tool for batch-level quality control.
Deferoxamine Mesylate CoA mostly includes findings from lab analyses of a specific batch. For each Deferoxamine Mesylate 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.
Deferoxamine Mesylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Deferoxamine Mesylate EP), Deferoxamine Mesylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Deferoxamine Mesylate USP).
LOOKING FOR A SUPPLIER?