Synopsis
Synopsis
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CEP/COS
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VMF
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EDQM
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USP
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JP
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Others
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Australia
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Data Compilation #PharmaFlow
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1. Cancidas
2. Caspofungin
3. Caspofungin Msd
4. L 743,872
5. L 743872
6. L-743,872
7. L-743872
8. L743,872
9. L743872
10. Mk 0991
11. Mk-0991
12. Mk0991
1. Cancidas
2. Caspofungin Diacetate
3. 179463-17-3
4. Mk 0991
5. L 743872
6. Cancidas (tn)
7. Mk-0991
8. Caspofungin Acetate- Bio-x
9. Schembl149293
10. L 743873
11. Chembl4297142
12. Caspofungin Acetate (jan/usan)
13. Mfcd08141839
14. Akos025401982
15. Ac-27763
16. Bc164293
17. D02501
18. F20901
19. 463c173
Molecular Weight | 1213.4 g/mol |
---|---|
Molecular Formula | C56H96N10O19 |
Hydrogen Bond Donor Count | 18 |
Hydrogen Bond Acceptor Count | 22 |
Rotatable Bond Count | 23 |
Exact Mass | 1212.68532087 g/mol |
Monoisotopic Mass | 1212.68532087 g/mol |
Topological Polar Surface Area | 487 Ų |
Heavy Atom Count | 85 |
Formal Charge | 0 |
Complexity | 1930 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 14 |
Undefined Atom Stereocenter Count | 2 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 3 |
1 of 2 | |
---|---|
Drug Name | Caspofungin acetate |
Active Ingredient | Caspofungin acetate |
Dosage Form | Injectable |
Route | injection |
Strength | 70mg/vial; 50mg/vial |
Market Status | Tentative Approval |
Company | Sandoz |
2 of 2 | |
---|---|
Drug Name | Caspofungin acetate |
Active Ingredient | Caspofungin acetate |
Dosage Form | Injectable |
Route | injection |
Strength | 70mg/vial; 50mg/vial |
Market Status | Tentative Approval |
Company | Sandoz |
- Treatment of invasive candidiasis in adult or paediatric patients.
- Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and/or itraconazole. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.
- Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropaenic adult or paediatric patients.
Fungal infections
Antifungal Agents
Substances that destroy fungi by suppressing their ability to grow or reproduce. They differ from FUNGICIDES, INDUSTRIAL because they defend against fungi present in human or animal tissues. (See all compounds classified as Antifungal Agents.)
Enzyme Inhibitors
Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. (See all compounds classified as Enzyme Inhibitors.)
J02AX04
Date of Issue : 2023-09-29
Valid Till : 2026-09-28
Written Confirmation Number : WC-0570
Address of the Firm : Plot No. 112, 113, 114, GIDC Estate Gozariya, Mehsana-382825, Gujarat, India
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Date of Issue : 2025-04-24
Valid Till : 2028-05-25
Written Confirmation Number : WC-0002
Address of the Firm : Plot No. A-2, A-2/1, A-/2, UPSIDC Industrial Area, Bijnor Road, Gajraula -244235...
Date of Issue : 2022-04-08
Valid Till : 2025-04-03
Written Confirmation Number : WC-0427
Address of the Firm : Plot No.49 & 50, J.N. Pharma City, Parawada (M), Visakhapatanam
Date of Issue : 2024-05-22
Valid Till : 2027-01-28
Written Confirmation Number : WC-0256
Address of the Firm : N.H. No. 08, Near GRID, Kabilpore-396424, Navsari, Gujarat, India
Date of Issue : 2022-08-08
Valid Till : 2025-08-08
Written Confirmation Number : WC-0383
Address of the Firm : Unit-ll, Sy No * Parts of 454,455,457,458 & 459 Chandampet-Village, Shankarampet...
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
NDC Package Code : 52076-6230
Start Marketing Date : 2018-11-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
NDC Package Code : 15894-0014
Start Marketing Date : 2017-11-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 62227-022
Start Marketing Date : 2021-07-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 57884-0030
Start Marketing Date : 2014-11-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (500g/500g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 69806-0092
Start Marketing Date : 2015-08-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (1kg/kg)
Marketing Category : EXPORT ONLY
NDC Package Code : 69766-064
Start Marketing Date : 2019-02-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 14474-037
Start Marketing Date : 2016-06-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 84517-053
Start Marketing Date : 2024-07-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast...
About the Company : Sumar Biotech LLP, registered in January 2018, is a startup approved by the Gujarat State Biotechnology Mission. It was founded by emerging entrepreneurs and a team of young yet ex...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
About the Company : Symbiotec, a leading API manufacturing company based in Indore, Central India, specializes in Cortico-Steroids and Steroid-Hormone APIs. Since 1995, their focus on R&D, sustainable...
About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
About the Company : Fishfa Biogenics, a division of Fishfa Rubbers Ltd., is a leading manufacturer and supplier of high-quality biological APIs. With GLP labs and WHO-GMP-certified facilities, Fishfa ...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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 : We are pharma manufacturing and API trading service which runs round the clock manufacturing services. We strive to deliver the best value to our customers to ever improving servic...
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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:
GSK acquired the rights to develop and commercialize GSK5458448 (ibrexafungerp), a glucan synthase inhibitor, and market Brexafemme for antifungal indications outside China.
Lead Product(s): Ibrexafungerp Citrate,Caspofungin
Therapeutic Area: Infections and Infectious Diseases Brand Name: Brexafemme
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: GSK
Deal Size: $401.0 million Upfront Cash: $90.0 million
Deal Type: Licensing Agreement March 01, 2024
Lead Product(s) : Ibrexafungerp Citrate,Caspofungin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : GSK
Deal Size : $401.0 million
Deal Type : Licensing Agreement
GSK Amends Deal with Scynexis Amid Brexafemme Manufacturing Woes
Details : GSK acquired the rights to develop and commercialize GSK5458448 (ibrexafungerp), a glucan synthase inhibitor, and market Brexafemme for antifungal indications outside China.
Product Name : Brexafemme
Product Type : Other Small Molecule
Upfront Cash : $90.0 million
March 01, 2024
Details:
Under the agreement GSK gains right to commercialize Brexafemme (ibrexafungerp), a novel glucan synthase inhibitor, for vulvovaginal candidiasis and RVVC while continuing to develop ibrexafungerp, in phase 3 trials for the potential treatment of invasive candidiasis.
Lead Product(s): Ibrexafungerp Citrate,Caspofungin
Therapeutic Area: Infections and Infectious Diseases Brand Name: Brexafemme
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: GSK
Deal Size: $593.0 million Upfront Cash: $90.0 million
Deal Type: Licensing Agreement June 21, 2023
Lead Product(s) : Ibrexafungerp Citrate,Caspofungin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : GSK
Deal Size : $593.0 million
Deal Type : Licensing Agreement
Details : Under the agreement GSK gains right to commercialize Brexafemme (ibrexafungerp), a novel glucan synthase inhibitor, for vulvovaginal candidiasis and RVVC while continuing to develop ibrexafungerp, in phase 3 trials for the potential treatment of invasive...
Product Name : Brexafemme
Product Type : Other Small Molecule
Upfront Cash : $90.0 million
June 21, 2023
Details:
Under the licensing agreement Clarus will develop and commercialize McGill’s proprietary technology designed to treat conditions associated with CoQ10 deficiencies in humans with Coenzyme-Q10 (Ubiquinone).
Lead Product(s): Coenzyme Q10,Caspofungin
Therapeutic Area: Rare Diseases and Disorders Brand Name: Ubiquinone
Study Phase: UndisclosedProduct Type: Enzyme
Sponsor: Clarus
Deal Size: $40.8 million Upfront Cash: $0.4 million
Deal Type: Licensing Agreement September 16, 2021
Lead Product(s) : Coenzyme Q10,Caspofungin
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Clarus
Deal Size : $40.8 million
Deal Type : Licensing Agreement
Details : Under the licensing agreement Clarus will develop and commercialize McGill’s proprietary technology designed to treat conditions associated with CoQ10 deficiencies in humans with Coenzyme-Q10 (Ubiquinone).
Product Name : Ubiquinone
Product Type : Enzyme
Upfront Cash : $0.4 million
September 16, 2021
RLD : No
TE Code : AP
Brand Name : CASPOFUNGIN ACETATE
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Approval Date : 2021-10-01
Application Number : 211263
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : CASPOFUNGIN ACETATE
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 70MG/VIAL
Approval Date : 2021-10-01
Application Number : 211263
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code :
Brand Name : CASPOFUNGIN ACETATE
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Approval Date : 2018-07-12
Application Number : 209489
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : CASPOFUNGIN ACETATE
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 70MG/VIAL
Approval Date : 2018-07-12
Application Number : 209489
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AP
Brand Name : CASPOFUNGIN ACETATE
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Approval Date : 2016-12-30
Application Number : 206110
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : CASPOFUNGIN ACETATE
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 70MG/VIAL
Approval Date : 2016-12-30
Application Number : 206110
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : CASPOFUNGIN ACETATE
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Approval Date : 2017-09-29
Application Number : 207092
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : CASPOFUNGIN ACETATE
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 70MG/VIAL
Approval Date : 2017-09-29
Application Number : 207092
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code :
Brand Name : CASPOFUNGIN ACETATE
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Approval Date : 2017-09-29
Application Number : 207650
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : CASPOFUNGIN ACETATE
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 70MG/VIAL
Approval Date : 2017-09-29
Application Number : 207650
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Regulatory Info :
Registration Country : Switzerland
Brand Name : Caspofungin Labatec
Dosage Form : Dry Sub
Dosage Strength : 50mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Caspofungin-Mepha
Dosage Form : Dry Sub
Dosage Strength : 70mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Sweden
Brand Name : Cancidas
Dosage Form : POWDER FOR CONCENTRATE FOR
Dosage Strength : 70 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Cancidas
Dosage Form : Caspofungin 50Mg 10Ml 1 Units Parenteral Use
Dosage Strength : 1 vial EV 50 mg 10 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Cancidas
Dosage Form : Powder to concentrate to the infusion fluid, resolution
Dosage Strength : 70 mg
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Cancidas
Dosage Form : Dry Sub
Dosage Strength : 50mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Norway
Brand Name : Cancidas
Dosage Form : Powder to concentrate to the infusion fluid, resolution
Dosage Strength : 50 mg
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Caspofungin Sandoz eco iv
Dosage Form : Dry Sub
Dosage Strength : 50mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Caspofungin Mylan
Dosage Form : Dry Sub
Dosage Strength : 50mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Caspofungin Viatris
Dosage Form : Inf Conc
Dosage Strength : 50mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Application : Disintegrants & Superdisintegrants
Excipient Details : Mannogem 2080 exhibits excellent flow, disintegration and compression properties.
Dosage Form : Orodispersible Tablet
Grade : Oral
Dosage Form : Orodispersible Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
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Dosage Form : Tablet
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Grade : Oral
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Application : Parenteral
Excipient Details : L-arginine is used as a cryoprotective agent and solution additive to help stabilize proteins against aggregation.
Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients
Excipient Details : Mannitol is a co-processed excipient with superior compactibility, lower disintegration time, and hygroscopicity.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : F-Melt Type C is a pharmaceutical excipient used in oral dosage forms like orally disintegrating tablets, sachets, dispersible tablets, chewable tablets and sublingual tablets.
Pharmacopoeia Ref : Conforms to Japanese Pharmaceu...
Technical Specs : Not Available
Ingredient(s) : Crospovidone
Dosage Form : Orodispersible Tablet
Grade : Oral
Application : Disintegrants & Superdisintegrants
Excipient Details : F-Melt Type M is used in various dosage forms like orally disintegrating tablets (ODTs), sachets, dispersible tablets, chewable tablets and sublingual formulations.
Pharmacopoeia Ref : Conforms to Japanese Pharmaceu...
Technical Specs : Not Available
Ingredient(s) : Crospovidone
Dosage Form : Capsule
Grade : Oral
Application : Taste Masking
Excipient Details : Ready mix sugar coating system.
Pharmacopoeia Ref : USP, EP, JP & having US DMF
Technical Specs : Sprayable sugar coating system for solid oral dosage form
Ingredient(s) : Hydroxypropyl Methyl Cellulose
Excipients by Applications
Application : Fillers, Diluents & Binders, Taste Masking
Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.
Dosage Form : Granule / Pellet, Tablet
Grade : Oral
Category : Fillers, Diluents & Binders, Granulation, Solubilizers
Application : Co-Processed Excipients
Excipient Details : Mannitol is a co-processed excipient with superior compactibility, lower disintegration time, and hygroscopicity.
Dosage Form : Injectable / Parenteral, Tablet
Grade : Parenteral, Oral
Category : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Dosage Form : Tablet, Orodispersible Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Taste Masking
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Advantol® 300 is a DC pharmaceutical excipient used to create soft chew or fast melt oral dosage forms through co-processing technology.
Dosage Form : Tablet, Orodispersible Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Compressol® SM, co-processed polyol, is a DC excipient of mannitol & sorbitol with superior compactibility, low disintegration time & hygroscopicity.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders
Brand Name : Mannogem XL Mannitol
Application : Chewable & Orodispersible Aids, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders
Excipient Details : Mannogem® XL is a DC spray-dried mannitol used to enhance mannitol formulation tabletability & provide superior binding & quick disintegration.
Global Sales Information
Company :
Caspofungin Acetate
Drug Cost (USD) : 71,985
Year : 2022
Prescribers :
Prescriptions : 41
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Caspofungin Acetate
Drug Cost (USD) : 1,931,343
Year : 2022
Prescribers : 904
Prescriptions : 3188
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Caspofungin Acetate
Drug Cost (USD) : 45,309
Year : 2021
Prescribers : 13
Prescriptions : 29
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Caspofungin Acetate
Drug Cost (USD) : 1,901,930
Year : 2021
Prescribers : 1086
Prescriptions : 3466
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Caspofungin Acetate
Drug Cost (USD) : 2,044,693
Year : 2020
Prescribers : 883
Prescriptions : 2675
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Caspofungin Acetate
Drug Cost (USD) : 66,887
Year : 2020
Prescribers : 16
Prescriptions : 52
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Caspofungin Acetate
Drug Cost (USD) : 179,140
Year : 2019
Prescribers : 28
Prescriptions : 103
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Caspofungin Acetate
Drug Cost (USD) : 1,939,239
Year : 2019
Prescribers : 380
Prescriptions : 1137
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Caspofungin Acetate
Drug Cost (USD) : 926,925
Year : 2018
Prescribers : 107
Prescriptions : 533
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Caspofungin Acetate
Drug Cost (USD) : 1,523,572
Year : 2018
Prescribers : 165
Prescriptions : 774
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Market Place
Patents & EXCLUSIVITIES
ABOUT THIS PAGE
36
PharmaCompass offers a list of Caspofungin 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 Caspofungin manufacturer or Caspofungin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Caspofungin manufacturer or Caspofungin supplier.
PharmaCompass also assists you with knowing the Caspofungin API Price utilized in the formulation of products. Caspofungin API Price is not always fixed or binding as the Caspofungin Price is obtained through a variety of data sources. The Caspofungin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Caspofungin Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Caspofungin Acetate, including repackagers and relabelers. The FDA regulates Caspofungin Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Caspofungin Acetate 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 Caspofungin Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Caspofungin Acetate supplier is an individual or a company that provides Caspofungin Acetate active pharmaceutical ingredient (API) or Caspofungin Acetate finished formulations upon request. The Caspofungin Acetate suppliers may include Caspofungin Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Caspofungin Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Caspofungin Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Caspofungin Acetate active pharmaceutical ingredient (API) in detail. Different forms of Caspofungin Acetate DMFs exist exist since differing nations have different regulations, such as Caspofungin Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Caspofungin Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Caspofungin Acetate USDMF includes data on Caspofungin Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Caspofungin Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Caspofungin Acetate 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 Caspofungin Acetate Drug Master File in Japan (Caspofungin Acetate JDMF) empowers Caspofungin Acetate 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 Caspofungin Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Caspofungin Acetate 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 Caspofungin Acetate Drug Master File in Korea (Caspofungin Acetate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Caspofungin Acetate. The MFDS reviews the Caspofungin Acetate KDMF as part of the drug registration process and uses the information provided in the Caspofungin Acetate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Caspofungin Acetate 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 Caspofungin Acetate API can apply through the Korea Drug Master File (KDMF).
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A Caspofungin Acetate written confirmation (Caspofungin Acetate WC) is an official document issued by a regulatory agency to a Caspofungin Acetate manufacturer, verifying that the manufacturing facility of a Caspofungin Acetate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Caspofungin Acetate APIs or Caspofungin Acetate finished pharmaceutical products to another nation, regulatory agencies frequently require a Caspofungin Acetate 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 Caspofungin Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Caspofungin Acetate 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 Caspofungin Acetate 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 Caspofungin Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Caspofungin Acetate NDC to their finished compounded human drug products, they may choose to do so.
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Caspofungin Acetate 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 Caspofungin Acetate 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 Caspofungin Acetate GMP manufacturer or Caspofungin Acetate GMP API supplier for your needs.
A Caspofungin Acetate CoA (Certificate of Analysis) is a formal document that attests to Caspofungin Acetate's compliance with Caspofungin Acetate specifications and serves as a tool for batch-level quality control.
Caspofungin Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Caspofungin Acetate 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.
Caspofungin Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Caspofungin Acetate EP), Caspofungin Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Caspofungin Acetate USP).