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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
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DOSAGE - POWDER;INTRAVENOUS - 50MG/VIAL
USFDA APPLICATION NUMBER - 21227
DOSAGE - POWDER;INTRAVENOUS - 70MG/VIAL
USFDA APPLICATION NUMBER - 21227
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ABOUT THIS PAGE
A Caspofungin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Caspofungin, including repackagers and relabelers. The FDA regulates Caspofungin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Caspofungin 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Caspofungin supplier is an individual or a company that provides Caspofungin active pharmaceutical ingredient (API) or Caspofungin finished formulations upon request. The Caspofungin suppliers may include Caspofungin API manufacturers, exporters, distributors and traders.
click here to find a list of Caspofungin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Caspofungin DMF (Drug Master File) is a document detailing the whole manufacturing process of Caspofungin active pharmaceutical ingredient (API) in detail. Different forms of Caspofungin DMFs exist exist since differing nations have different regulations, such as Caspofungin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Caspofungin DMF submitted to regulatory agencies in the US is known as a USDMF. Caspofungin USDMF includes data on Caspofungin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Caspofungin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Caspofungin 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 Drug Master File in Japan (Caspofungin JDMF) empowers Caspofungin 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Caspofungin 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 Caspofungin 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 Caspofungin Drug Master File in Korea (Caspofungin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Caspofungin. The MFDS reviews the Caspofungin KDMF as part of the drug registration process and uses the information provided in the Caspofungin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Caspofungin 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Caspofungin suppliers with KDMF on PharmaCompass.
A Caspofungin written confirmation (Caspofungin WC) is an official document issued by a regulatory agency to a Caspofungin manufacturer, verifying that the manufacturing facility of a Caspofungin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Caspofungin APIs or Caspofungin finished pharmaceutical products to another nation, regulatory agencies frequently require a Caspofungin WC (written confirmation) as part of the regulatory process.
click here to find a list of Caspofungin 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 Caspofungin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Caspofungin 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Caspofungin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Caspofungin suppliers with NDC on PharmaCompass.
Caspofungin 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 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 GMP manufacturer or Caspofungin GMP API supplier for your needs.
A Caspofungin CoA (Certificate of Analysis) is a formal document that attests to Caspofungin's compliance with Caspofungin specifications and serves as a tool for batch-level quality control.
Caspofungin CoA mostly includes findings from lab analyses of a specific batch. For each Caspofungin 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Caspofungin EP), Caspofungin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Caspofungin USP).
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