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DOSAGE - INJECTABLE;INTRAVENOUS - EQ 100MG BA...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 100MG BASE/VIAL
USFDA APPLICATION NUMBER - 21506
DOSAGE - INJECTABLE;INTRAVENOUS - EQ 50MG BAS...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 50MG BASE/VIAL
USFDA APPLICATION NUMBER - 21506
DOSAGE - SOLUTION;INTRAVENOUS - EQ 100MG BASE...DOSAGE - SOLUTION;INTRAVENOUS - EQ 100MG BASE/100ML (EQ 1MG BASE/ML)
USFDA APPLICATION NUMBER - 216142
DOSAGE - SOLUTION;INTRAVENOUS - EQ 150MG BASE...DOSAGE - SOLUTION;INTRAVENOUS - EQ 150MG BASE/150ML (EQ 1MG BASE/ML)
USFDA APPLICATION NUMBER - 216142
DOSAGE - SOLUTION;INTRAVENOUS - EQ 50MG BASE/...DOSAGE - SOLUTION;INTRAVENOUS - EQ 50MG BASE/50ML (EQ 1MG BASE/ML)
USFDA APPLICATION NUMBER - 216142
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ABOUT THIS PAGE
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PharmaCompass offers a list of Micafungin 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 Micafungin manufacturer or Micafungin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Micafungin manufacturer or Micafungin supplier.
PharmaCompass also assists you with knowing the Micafungin API Price utilized in the formulation of products. Micafungin API Price is not always fixed or binding as the Micafungin Price is obtained through a variety of data sources. The Micafungin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Micafungin Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Micafungin Sodium, including repackagers and relabelers. The FDA regulates Micafungin Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Micafungin Sodium 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 Micafungin Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Micafungin Sodium supplier is an individual or a company that provides Micafungin Sodium active pharmaceutical ingredient (API) or Micafungin Sodium finished formulations upon request. The Micafungin Sodium suppliers may include Micafungin Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Micafungin Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Micafungin Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Micafungin Sodium active pharmaceutical ingredient (API) in detail. Different forms of Micafungin Sodium DMFs exist exist since differing nations have different regulations, such as Micafungin Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Micafungin Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Micafungin Sodium USDMF includes data on Micafungin Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Micafungin Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Micafungin Sodium 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 Micafungin Sodium Drug Master File in Japan (Micafungin Sodium JDMF) empowers Micafungin Sodium 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 Micafungin Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Micafungin Sodium 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 Micafungin Sodium 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 Micafungin Sodium Drug Master File in Korea (Micafungin Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Micafungin Sodium. The MFDS reviews the Micafungin Sodium KDMF as part of the drug registration process and uses the information provided in the Micafungin Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Micafungin Sodium 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 Micafungin Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Micafungin Sodium suppliers with KDMF on PharmaCompass.
A Micafungin Sodium written confirmation (Micafungin Sodium WC) is an official document issued by a regulatory agency to a Micafungin Sodium manufacturer, verifying that the manufacturing facility of a Micafungin Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Micafungin Sodium APIs or Micafungin Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Micafungin Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Micafungin Sodium 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 Micafungin Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Micafungin Sodium 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 Micafungin Sodium 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 Micafungin Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Micafungin Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Micafungin Sodium suppliers with NDC on PharmaCompass.
Micafungin Sodium 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 Micafungin Sodium 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 Micafungin Sodium GMP manufacturer or Micafungin Sodium GMP API supplier for your needs.
A Micafungin Sodium CoA (Certificate of Analysis) is a formal document that attests to Micafungin Sodium's compliance with Micafungin Sodium specifications and serves as a tool for batch-level quality control.
Micafungin Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Micafungin Sodium 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.
Micafungin Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Micafungin Sodium EP), Micafungin Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Micafungin Sodium USP).
