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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API SUPPLIERS
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
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KDMF
ASMF
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Fishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
JDMF
EU-WC
NDC
KDMF
ASMF
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
ASMF
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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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API Imports and Exports
Drugs in Development
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Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
CAS Number : 135575-42-7
End Use API : Caspofungin
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
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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
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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 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.
click here to find a list of Caspofungin Acetate 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 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).
click here to find a list of Caspofungin Acetate suppliers with KDMF on PharmaCompass.
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.
click here to find a list of Caspofungin Acetate 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 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.
click here to find a list of Caspofungin Acetate suppliers with NDC on PharmaCompass.
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).
