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1. 5-(5-fluoro-2-oxo-1,2-dihydroindolylidenemethyl)-2,4-dimethyl-1h-pyrrole-3-carboxylic Acid (2-diethylaminoethyl)amide
2. Su 011248
3. Su 11248
4. Su-011248
5. Su-11248
6. Su011248
7. Su11248
8. Sunitinib
9. Sutent
1. 341031-54-7
2. Sutent
3. Su011248 L-malate Salt
4. Sunitinib Malate [usan]
5. Pha-290940ad
6. Su010398
7. Sunitinib L-malate
8. Su-011248 L-malate Salt
9. Lvx8n1ut73
10. Su-010398
11. (z)-n-(2-(diethylamino)ethyl)-5-((5-fluoro-2-oxoindolin-3-ylidene)methyl)-2,4-dimethyl-1h-pyrrole-3-carboxamide (s)-2-hydroxysuccinate
12. Su 11248
13. N-[2-(diethylamino)ethyl]-5-[(z)-(5-fluoro-2-oxo-1h-indol-3-ylidene)methyl]-2,4-dimethyl-1h-pyrrole-3-carboxamide;(2s)-2-hydroxybutanedioic Acid
14. Butanedioic Acid, Hydroxy-, (2s)-, Compd. With N-(2-(diethylamino)ethyl)-5-((z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl)-2,4-dimethyl-1h-pyrrole-3-carboxamide (1:1)
15. N-(2-(diethylamino)ethyl)-5-((z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl)-2,4-dimethyl-1h-pyrrole-3-carboxamide (2s)-hydroxybutanedioate
16. (2s)-2-hydroxybutanedioic Acid; N-[2-(diethylamino)ethyl]-5-{[(3z)-5-fluoro-2-oxo-2,3-dihydro-1h-indol-3-ylidene]methyl}-2,4-dimethyl-1h-pyrrole-3-carboxamide
17. Butanedioic Acid, 2-hydroxy-, (2s)-, Compd. With N-[2-(diethylamino)ethyl]-5-[(z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl]-2,4-dimethyl-1h-pyrrole-3-carboxamide (1:1)
18. Su 011248
19. Unii-lvx8n1ut73
20. Butanedioic Acid, 2-hydroxy-, (2s)-, Compd. With N-(2-(diethylamino)ethyl)-5-((z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl)-2,4-dimethyl-1h-pyrrole-3-carboxamide (1:1)
21. Mfcd08282795
22. Pdgf Tk Antagonist
23. Sutent (tn)
24. Sunitinib Malate- Bio-x
25. Sutent (tn) (pfizer)
26. Sunitinib Malate (sutent)
27. Chembl1567
28. Su 11248 (malate)
29. Su-11248 L-malate Salt
30. Sunitinib Malate [mi]
31. Sunitinib Malate (jan/usan)
32. Sunitinib Malate [jan]
33. Schembl1258610
34. Schembl1772213
35. Dtxsid4046492
36. Sunitinib Malate [vandf]
37. Sunitinib Malate [mart.]
38. Pnu-290940ad
39. Sunitinib Malate [who-dd]
40. Hms3261h09
41. Sunitinib Malate, >=98% (hplc)
42. Tox21_500514
43. Nsc736511
44. S1042
45. Su-11248j
46. Akos005145765
47. Akos025149097
48. Sunitinib Malate (sunitinib L-malate)
49. Sunitinib Malate [orange Book]
50. Ccg-221818
51. Cs-0177
52. Ks-5023
53. Ncgc00261199-01
54. Bs164428
55. Hy-10255
56. Am20090634
57. Sw219407-1
58. D06402
59. 031s547
60. A822079
61. J-019449
62. Q27283213
63. Sunitinib Malate
64. 341031-54-7
65. Sutent
66. Su-11248
67. Sunitinib
68. (2s)-2-hydroxybutanedioic Acid Compd. With N-[2-(diethylamino)ethyl]-5-[(z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl]-2,4-dimethyl-1h-pyrrole-3-carboxamide (1:1)
69. (z)-n-(2-(diethylamino)ethyl)-5-((5-fluoro-2-oxoindolin-3-ylidene)methyl)-2,4-dimethyl-1h-pyrrole-3-carboxamide(s)-2-hydroxysuccinate
70. 1h-pyrrole-3-carboxamide, N-(2-(diethylamino)ethyl)-5-((z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl)-2,4-dimethyl-, (2s)-hydroxybutanedioate (1:1)
71. 1h-pyrrole-3-carboxamide,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl]-2,4-dimethyl-, (2s)-hydroxybutanedioate (1:1)
72. 1h-pyrrole-3-carboxamide,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl]-2,4-dimethyl-, Malate Salt
73. Butanedioic Acid, (2s)-, Compd. With N-[2-(diethylamino)ethyl]-5-[(z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl]-2,4-dimethyl-1h-pyrrole-3-carboxamide (1:1)
74. Butanedioic Acid, (2s)-, Compd. With N-[2-(diethylamino)ethyl]-5-[(z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl]-2,4-dimethyl-1h-pyrrole-3-carboxamide (1:1) (ca Index Name)
75. N-(2-diethylamino)ethyl)-5-((z)-(5-fluoro-2-oxo-1,2-dihydro-3h-indol-3-ylidene)methyl)-2,4-dimethyl-1h-pyrrole-3-carboxamide Hydrogen (2s)-2-hydroxybutanedioate
76. N-[2-(diethylamino)ethyl]-5-[(z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidine)methyl]-2,4-dimethyl-1h-pyrrole-3-carboxamide (2s)-2-hydroxybutanedioate Salt
Molecular Weight | 532.6 g/mol |
---|---|
Molecular Formula | C26H33FN4O7 |
Hydrogen Bond Donor Count | 6 |
Hydrogen Bond Acceptor Count | 9 |
Rotatable Bond Count | 10 |
Exact Mass | 532.23332757 g/mol |
Monoisotopic Mass | 532.23332757 g/mol |
Topological Polar Surface Area | 172 Ų |
Heavy Atom Count | 38 |
Formal Charge | 0 |
Complexity | 765 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 1 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 2 | |
---|---|
Drug Name | Sunitinib malate |
Drug Label | SUTENT, an oral multi-kinase inhibitor, is the malate salt of sunitinib. Sunitinib malate is described chemically as Butanedioic acid, hydroxy-, (2S)-, compound with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)meth... |
Active Ingredient | Sunitinib malate |
Dosage Form | Capsule |
Route | Oral |
Strength | eq 50mg base; eq 12.5mg base; eq 25mg base; eq 37.5mg base |
Market Status | Prescription |
Company | Mylan Pharms |
2 of 2 | |
---|---|
Drug Name | Sunitinib malate |
Drug Label | SUTENT, an oral multi-kinase inhibitor, is the malate salt of sunitinib. Sunitinib malate is described chemically as Butanedioic acid, hydroxy-, (2S)-, compound with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)meth... |
Active Ingredient | Sunitinib malate |
Dosage Form | Capsule |
Route | Oral |
Strength | eq 50mg base; eq 12.5mg base; eq 25mg base; eq 37.5mg base |
Market Status | Prescription |
Company | Mylan Pharms |
* Gastrointestinal stromal tumour (GIST):
Sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib mesilate treatment due to resistance or intolerance.
* Metastatic renal cell carcinoma (MRCC):
Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.
* Pancreatic neuroendocrine tumours (pNET):
Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults.
Experience with Sutent as first-line treatment is limited (see section 5. 1).
Angiogenesis Inhibitors
Agents and endogenous substances that antagonize or inhibit the development of new blood vessels. (See all compounds classified as Angiogenesis Inhibitors.)
Antineoplastic Agents
Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)
Protein Kinase Inhibitors
Agents that inhibit PROTEIN KINASES. (See all compounds classified as Protein Kinase Inhibitors.)
L01EX01
Date of Issue : 2024-11-28
Valid Till : 2024-07-15
Written Confirmation Number : WC-0327n
Address of the Firm : Plot No 116/117, KIADB Industrial Area, Jigani, Bangalore,Karnataka, India
Date of Issue : 2022-09-16
Valid Till : 2025-08-08
Written Confirmation Number : WC-0041
Address of the Firm : Unit-I, Survey No.10, I.D.A, Gaddapotharam Village, Jinnaram Mandal,Medak Dist, ...
Date of Issue : 2023-07-03
Valid Till : 2025-07-02
Written Confirmation Number : WC-0213
Address of the Firm : Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakh...
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm : MIs. MSN Laboratories Private Limited, Unit-II, sv. No, 50, Kardanur (Village), ...
Date of Issue : 2020-02-10
Valid Till : 2022-05-05
Written Confirmation Number : WC-0349A8
Address of the Firm : Unit-||, Sy. No. 50, Kardanur Village, Patti/Post Patancheru Mandal,Sangareddy D...
Date of Issue : 2022-08-31
Valid Till : 2025-07-21
Written Confirmation Number : WC-0198
Address of the Firm : R-282, Plant-3, TTC Area of MIDC, Thane- Belapur Road, Rabale, Navi Mumbai-400 7...
Date of Issue : 2021-06-11
Valid Till : 2022-07-02
Written Confirmation Number : WC-0147A3
Address of the Firm : 100% EOU, Raichur Industrial Growth Centre, Plot No. 33, 33A, 40-47, Chicksugur-...
Date of Issue : 2021-01-08
Valid Till : 2022-07-25
Written Confirmation Number : WC-0159A3
Address of the Firm : A-7/A-8 MIDC, Industrial Area, Ahmednagar,414111,Maharastra,India
Date of Issue : 2019-10-11
Valid Till : 2022-07-02
Written Confirmation Number : WC-0157
Address of the Firm : Plot No. 1A/2, MIDC, Taloja, Panvel, Dist. Raigad, Maharashtra State
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
NDC Package Code : 53296-0091
Start Marketing Date : 2010-06-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
NDC Package Code : 16436-0091
Start Marketing Date : 2010-06-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 68554-0078
Start Marketing Date : 2006-01-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 54893-0081
Start Marketing Date : 2018-11-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 68724-1234
Start Marketing Date : 2019-07-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 82920-037
Start Marketing Date : 2023-09-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 53183-4012
Start Marketing Date : 2018-03-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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CAS Number : 56341-41-4
End Use API : Sunitinib
About The Company : Aventus Labs is a forward-thinking pharmaceutical company committed to developing and delivering high-quality, effective healthcare solutions. With a focus on r...
N-(2-(Diethylamino)ethyl)-5-formyl-2,4-dimethyl-1H...
CAS Number : 356068-86-5
End Use API : Sunitinib
About The Company : Beijing Lunarsun pharma is a professional manufacturer of API and intermediates. The factory is approved by US FDA. According to EU and US FDA's requirement, we...
5-Formyl-2,4-dimethyl-1H-pyrrole-3-carboxylic acid
CAS Number : 253870-02-9
End Use API : Sunitinib
About The Company : Beijing Lunarsun pharma is a professional manufacturer of API and intermediates. The factory is approved by US FDA. According to EU and US FDA's requirement, we...
Ethyl 5-formyl-2,4-dimethyl-1H-pyrrole-3-carboxyla...
CAS Number : 2199-59-9
End Use API : Sunitinib
About The Company : Beijing Lunarsun pharma is a professional manufacturer of API and intermediates. The factory is approved by US FDA. According to EU and US FDA's requirement, we...
2,4-Dimethyl-1H-Pyrrole-3-carboxylic acid ethyl es...
CAS Number : 2199-51-1
End Use API : Sunitinib
About The Company : Beijing Lunarsun pharma is a professional manufacturer of API and intermediates. The factory is approved by US FDA. According to EU and US FDA's requirement, we...
CAS Number : 56341-41-4
End Use API : Sunitinib
About The Company : Beijing Lunarsun pharma is a professional manufacturer of API and intermediates. The factory is approved by US FDA. According to EU and US FDA's requirement, we...
N-(2-(Diethylamino)ethyl)-5-formyl-2,4-dimethyl-1H...
CAS Number : 356068-86-5
End Use API : Sunitinib
About The Company : Chengda Pharmaceutical Co., Ltd. was founded in 1999. It is located in the Hangzhou-Jiaxing-Huzhou plain, Jiashan Economic & Technological Development Zone (nat...
CAS Number : 56341-41-4
End Use API : Sunitinib
About The Company : Fujian South Pharmaceutical Co., Ltd. (Southern Pharmaceutical) was established in September 2001 and is located in Mingxi County, Fujian Province. After 16 ye...
N-(2-(Diethylamino)ethyl)-5-formyl-2,4-dimethyl-1H...
CAS Number : 356068-86-5
End Use API : Sunitinib
About The Company : Fujian South Pharmaceutical Co., Ltd. (Southern Pharmaceutical) was established in September 2001 and is located in Mingxi County, Fujian Province. After 16 ye...
N-(2-(diethylamino)ethyl)-5 -formyl-2,4-dimethyl- ...
CAS Number : 356068-86-5
End Use API : Sunitinib
About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Sunitinib Zentiva
Dosage Form : Kaps
Dosage Strength : 12.5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Sunitinib Zentiva
Dosage Form : Kaps
Dosage Strength : 25mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Sunitinib Zentiva
Dosage Form : Caps
Dosage Strength : 50mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Generic
Registration Country : Poland
Brand Name :
Dosage Form :
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Poland
Regulatory Info : Generic Submission Scheduled
Registration Country : Germany
Brand Name :
Dosage Form : CAPSULE
Dosage Strength : 50MG
Packaging : Capsule (Box/Bottle)
Approval Date :
Application Number :
Regulatory Info : Generic Submission Scheduled
Registration Country : Germany
Regulatory Info :
Registration Country : Portugal
Brand Name :
Dosage Form : Capsule
Dosage Strength : 37.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Portugal
Regulatory Info :
Registration Country : Sweden
Brand Name : SUTENT
Dosage Form : HARD CAPSULES
Dosage Strength : 37.5 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Sutent
Dosage Form : Capsule, hard
Dosage Strength : 25 mg
Packaging : Box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Sunitinib-Teva
Dosage Form : Kaps
Dosage Strength : 50mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Sunitinib Mylan
Dosage Form : Caps
Dosage Strength : 12.5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN : Class A
Dosage Form : Kaps
Dosage Strength : 12.5mg
Price Per Pack (Euro) : 800.81
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN : Class A
Dosage Form : Caps
Dosage Strength : 50mg
Price Per Pack (Euro) : 3046.34
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN : Class A
Dosage Form : Kaps
Dosage Strength : 25mg
Price Per Pack (Euro) : 1601.5
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Caps
Dosage Strength : 12.5mg
Price Per Pack (Euro) : 889.78
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Caps
Dosage Strength : 25mg
Price Per Pack (Euro) : 1779.44
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Caps
Dosage Strength : 50mg
Price Per Pack (Euro) : 3384.8
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Caps
Dosage Strength : 12.5mg
Price Per Pack (Euro) : 800.81
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Capsule, hard
Dosage Strength : 12.5 mg
Price Per Pack (Euro) : 1,513.02
Published in :
Country : Norway
RX/OTC/DISCN :
Dosage Form : Capsule, hard
Dosage Strength : 25 mg
Price Per Pack (Euro) : 3,021.22
Published in :
Country : Norway
RX/OTC/DISCN :
Dosage Form : Capsule, hard
Dosage Strength : 50 mg
Price Per Pack (Euro) : 6,037.42
Published in :
Country : Norway
RX/OTC/DISCN :
Main Therapeutic Indication : Oncology
Currency : USD
2019 Revenue in Millions : 936
2018 Revenue in Millions : 1,049
Growth (%) : -11
Main Therapeutic Indication : Oncology
Currency : USD
2020 Revenue in Millions : 819
2019 Revenue in Millions : 936
Growth (%) : -13
Main Therapeutic Indication : Oncology
Currency : USD
2021 Revenue in Millions : 673
2020 Revenue in Millions : 819
Growth (%) : -18
Main Therapeutic Indication : Oncology
Currency : USD
2022 Revenue in Millions : 347
2021 Revenue in Millions : 673
Growth (%) : -48
Main Therapeutic Indication : Oncology
Currency : USD
2023 Revenue in Millions : 180
2022 Revenue in Millions : 347
Growth (%) : -48
Main Therapeutic Indication : Oncology
Currency : USD
2014 Revenue in Millions : -2.40%
2013 Revenue in Millions :
Growth (%) :
Main Therapeutic Indication : Oncology
Currency : USD
2015 Revenue in Millions : 1,174
2014 Revenue in Millions : 1,120
Growth (%) : -5%
Main Therapeutic Indication : Oncology
Currency : USD
2016 Revenue in Millions : 1,095
2015 Revenue in Millions : 1,120
Growth (%) : -2
Main Therapeutic Indication : Oncology
Currency : USD
2017 Revenue in Millions : 1,081
2016 Revenue in Millions : 1,096
Growth (%) : -1
Main Therapeutic Indication : Oncology
Currency : USD
2018 Revenue in Millions : 1,049
2017 Revenue in Millions : 1,081
Growth (%) : -3%
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Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Sunitinib Malate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sunitinib Malate, including repackagers and relabelers. The FDA regulates Sunitinib Malate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sunitinib Malate 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 Sunitinib Malate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sunitinib Malate supplier is an individual or a company that provides Sunitinib Malate active pharmaceutical ingredient (API) or Sunitinib Malate finished formulations upon request. The Sunitinib Malate suppliers may include Sunitinib Malate API manufacturers, exporters, distributors and traders.
click here to find a list of Sunitinib Malate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sunitinib Malate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sunitinib Malate active pharmaceutical ingredient (API) in detail. Different forms of Sunitinib Malate DMFs exist exist since differing nations have different regulations, such as Sunitinib Malate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sunitinib Malate DMF submitted to regulatory agencies in the US is known as a USDMF. Sunitinib Malate USDMF includes data on Sunitinib Malate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sunitinib Malate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sunitinib Malate 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 Sunitinib Malate Drug Master File in Japan (Sunitinib Malate JDMF) empowers Sunitinib Malate 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 Sunitinib Malate JDMF during the approval evaluation for pharmaceutical products. At the time of Sunitinib Malate 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 Sunitinib Malate 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 Sunitinib Malate Drug Master File in Korea (Sunitinib Malate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sunitinib Malate. The MFDS reviews the Sunitinib Malate KDMF as part of the drug registration process and uses the information provided in the Sunitinib Malate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sunitinib Malate 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 Sunitinib Malate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sunitinib Malate suppliers with KDMF on PharmaCompass.
A Sunitinib Malate written confirmation (Sunitinib Malate WC) is an official document issued by a regulatory agency to a Sunitinib Malate manufacturer, verifying that the manufacturing facility of a Sunitinib Malate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sunitinib Malate APIs or Sunitinib Malate finished pharmaceutical products to another nation, regulatory agencies frequently require a Sunitinib Malate WC (written confirmation) as part of the regulatory process.
click here to find a list of Sunitinib Malate 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 Sunitinib Malate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sunitinib Malate 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 Sunitinib Malate 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 Sunitinib Malate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sunitinib Malate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sunitinib Malate suppliers with NDC on PharmaCompass.
Sunitinib Malate 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 Sunitinib Malate 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 Sunitinib Malate GMP manufacturer or Sunitinib Malate GMP API supplier for your needs.
A Sunitinib Malate CoA (Certificate of Analysis) is a formal document that attests to Sunitinib Malate's compliance with Sunitinib Malate specifications and serves as a tool for batch-level quality control.
Sunitinib Malate CoA mostly includes findings from lab analyses of a specific batch. For each Sunitinib Malate 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.
Sunitinib Malate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sunitinib Malate EP), Sunitinib Malate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sunitinib Malate USP).
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