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API SUPPLIERS
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USDMF
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 : 2018-10-29
Pay. Date : 2018-05-14
DMF Number : 32812
Submission : 2018-06-17
Status :
Type : II
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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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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 Funguard (TN) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Funguard (TN), including repackagers and relabelers. The FDA regulates Funguard (TN) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Funguard (TN) 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 Funguard (TN) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Funguard (TN) supplier is an individual or a company that provides Funguard (TN) active pharmaceutical ingredient (API) or Funguard (TN) finished formulations upon request. The Funguard (TN) suppliers may include Funguard (TN) API manufacturers, exporters, distributors and traders.
click here to find a list of Funguard (TN) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Funguard (TN) DMF (Drug Master File) is a document detailing the whole manufacturing process of Funguard (TN) active pharmaceutical ingredient (API) in detail. Different forms of Funguard (TN) DMFs exist exist since differing nations have different regulations, such as Funguard (TN) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Funguard (TN) DMF submitted to regulatory agencies in the US is known as a USDMF. Funguard (TN) USDMF includes data on Funguard (TN)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Funguard (TN) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Funguard (TN) 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 Funguard (TN) Drug Master File in Japan (Funguard (TN) JDMF) empowers Funguard (TN) 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 Funguard (TN) JDMF during the approval evaluation for pharmaceutical products. At the time of Funguard (TN) 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 Funguard (TN) 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 Funguard (TN) Drug Master File in Korea (Funguard (TN) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Funguard (TN). The MFDS reviews the Funguard (TN) KDMF as part of the drug registration process and uses the information provided in the Funguard (TN) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Funguard (TN) 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 Funguard (TN) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Funguard (TN) suppliers with KDMF on PharmaCompass.
A Funguard (TN) written confirmation (Funguard (TN) WC) is an official document issued by a regulatory agency to a Funguard (TN) manufacturer, verifying that the manufacturing facility of a Funguard (TN) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Funguard (TN) APIs or Funguard (TN) finished pharmaceutical products to another nation, regulatory agencies frequently require a Funguard (TN) WC (written confirmation) as part of the regulatory process.
click here to find a list of Funguard (TN) 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 Funguard (TN) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Funguard (TN) 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 Funguard (TN) 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 Funguard (TN) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Funguard (TN) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Funguard (TN) suppliers with NDC on PharmaCompass.
Funguard (TN) 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 Funguard (TN) 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 Funguard (TN) GMP manufacturer or Funguard (TN) GMP API supplier for your needs.
A Funguard (TN) CoA (Certificate of Analysis) is a formal document that attests to Funguard (TN)'s compliance with Funguard (TN) specifications and serves as a tool for batch-level quality control.
Funguard (TN) CoA mostly includes findings from lab analyses of a specific batch. For each Funguard (TN) 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.
Funguard (TN) may be tested according to a variety of international standards, such as European Pharmacopoeia (Funguard (TN) EP), Funguard (TN) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Funguard (TN) USP).
