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
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27585
Submission : 2013-11-27
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-14
Pay. Date : 2013-03-20
DMF Number : 26978
Submission : 2013-06-21
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22770
Submission : 2009-05-12
Status :
Type : II
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Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
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-2/2, UPSIDC Industrial Area, Bijnor Road, Gajraula -24423...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Caspofungin
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 50MG
Packaging :
Approval Date : 2017-01-10
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Caspofungin
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 70MG
Packaging :
Approval Date : 2017-01-10
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info : Authorised
Registration Country : Malta
Brand Name : Caspofungin
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 50MG
Packaging :
Approval Date : 2017-01-13
Application Number :
Regulatory Info : Authorised
Registration Country : Malta
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info : Authorised
Registration Country : Malta
Brand Name : Caspofungin
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 70MG
Packaging :
Approval Date : 2017-01-13
Application Number :
Regulatory Info : Authorised
Registration Country : Malta
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Caspofungin Orion
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 50mg
Packaging :
Approval Date : 30/01/2017
Application Number : 20151128000060
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Caspofungin Orion
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 70mg
Packaging :
Approval Date : 30/01/2017
Application Number : 20151128000084
Regulatory Info : Approved
Registration Country : Sweden
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Caspofungin
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 50MG
Packaging :
Approval Date : 2017-01-09
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Caspofungin
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 70MG
Packaging :
Approval Date : 2017-01-09
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Furnace
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 50MG
Packaging :
Approval Date : 2018-11-27
Application Number : 83627
Regulatory Info : Cancelled
Registration Country : Spain
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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Caspofungin 50mg Aspen
Dosage Form : INF
Dosage Strength : 50mg
Packaging : 10X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Caspofungin 70mg Aspen
Dosage Form : INF
Dosage Strength : 70mg
Packaging : 10X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Casfolred 50
Dosage Form : INF
Dosage Strength : 50mg
Packaging : 10.5X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Casfolred 70
Dosage Form : INF
Dosage Strength : 70mg
Packaging : 10.5X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Powder Concentrate for...
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Powder Concentrate for...
Dosage Strength : 70MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Regulatory Info : Dossier Availability: Q2 2024
Registration Country : Poland
Brand Name :
Dosage Form : Powder for Infusion So...
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Dossier Availability: Q2 2024
Registration Country : Poland
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Regulatory Info : Dossier Availability: Q2 2024
Registration Country : Poland
Brand Name :
Dosage Form : Powder for Infusion So...
Dosage Strength : 70MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Dossier Availability: Q2 2024
Registration Country : Poland
NanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.
Regulatory Info :
Registration Country : Iran
Brand Name : Letocan
Dosage Form : Vial
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
NanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.
Regulatory Info :
Registration Country : Iran
Brand Name : Letocan
Dosage Form : Vial
Dosage Strength : 70MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Powder For Concentrate...
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Powder For Concentrate...
Dosage Strength : 70MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
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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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Rochem International Inc
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Parenteral
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Tablet
Grade : Oral
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.
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Application : Parenteral, Thickeners and Stabilizers
Excipient Details : Sucrose is used to stabilize proteins, lipids, carbohydrates, ADCs & vaccines. It is also used as a cryopreservative in cell-based bioprocesses.
Pharmacopoeia Ref : USP NF, EP, JP, ChP
Technical Specs : Low Endotoxin, Low Metals
Ingredient(s) : Saccharose Excipient
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Application : API Stability Enhancers, Thickeners and Stabilizers
Excipient Details : Used to stabilize proteins in injectable biologic formulations. Also used as a nutrient for cell culture media in upstream.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised pa...
Ingredient(s) : L-Arginine Excipient
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Dosage Form : Injectable / Parenteral
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Excipient Details : L-Arginine is used as a cryoprotective agent and solution additive to stabilize proteins. It is used in injectable biologic & vaccine formulations.
Pharmacopoeia Ref : USP, EP, JP, ChP
Technical Specs : Low Endotoxin, Low Metals
Ingredient(s) : L-Arginine Excipient
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
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Grade : Parenteral, Oral
Application : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers
Excipient Details : D-Mannitol protects proteins from denaturation & degradation. It is used as a stabilizer in liquid products including biologic injectables & vaccines.
Pharmacopoeia Ref : USP, EP, BP, JP, ChP
Technical Specs : Low Endotoxin, Low Metals
Ingredient(s) : Mannitol
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Pharmacopoeia Ref : USP NF, EP, JP, ChP
Technical Specs : Low Endotoxin, Low Metals
Ingredient(s) : Saccharose Excipient
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
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Excipient Details : Used to stabilize proteins in injectable biologic formulations. Also used as a nutrient for cell culture media in upstream.
Pharmacopoeia Ref : On Request
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Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
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Excipient Details : L-Arginine is used as a cryoprotective agent and solution additive to stabilize proteins. It is used in injectable biologic & vaccine formulations.
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Co-Processed Excipients
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Dosage Form : Injectable / Parenteral
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Grade : Biopharma Grade
Application : API Stability Enhancers, Thickeners and Stabilizers
Excipient Details : Used to stabilize proteins in injectable biologic formulations. Also used as a nutrient for cell culture media in upstream.
Pharmacopoeia Ref : On Request
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Ingredient(s) : L-Arginine Excipient
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ABOUT THIS PAGE
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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 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).
