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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
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API Imports and Exports
Drugs in Development
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DOSAGE - TABLET;ORAL - 100MG
USFDA APPLICATION NUMBER - 19758
DOSAGE - TABLET;ORAL - 200MG
USFDA APPLICATION NUMBER - 19758
DOSAGE - TABLET;ORAL - 25MG
USFDA APPLICATION NUMBER - 19758
DOSAGE - TABLET;ORAL - 50MG
USFDA APPLICATION NUMBER - 19758
DOSAGE - SUSPENSION;ORAL - 50MG/ML
USFDA APPLICATION NUMBER - 203479
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21590
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21590
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21590
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21590
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21590
Related Excipient Companies
EUROAPI
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ABOUT THIS PAGE
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PharmaCompass offers a list of Clozapine 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 Clozapine manufacturer or Clozapine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Clozapine manufacturer or Clozapine supplier.
PharmaCompass also assists you with knowing the Clozapine API Price utilized in the formulation of products. Clozapine API Price is not always fixed or binding as the Clozapine Price is obtained through a variety of data sources. The Clozapine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fazaclo ODT manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fazaclo ODT, including repackagers and relabelers. The FDA regulates Fazaclo ODT manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fazaclo ODT 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 Fazaclo ODT manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fazaclo ODT supplier is an individual or a company that provides Fazaclo ODT active pharmaceutical ingredient (API) or Fazaclo ODT finished formulations upon request. The Fazaclo ODT suppliers may include Fazaclo ODT API manufacturers, exporters, distributors and traders.
click here to find a list of Fazaclo ODT suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fazaclo ODT DMF (Drug Master File) is a document detailing the whole manufacturing process of Fazaclo ODT active pharmaceutical ingredient (API) in detail. Different forms of Fazaclo ODT DMFs exist exist since differing nations have different regulations, such as Fazaclo ODT USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fazaclo ODT DMF submitted to regulatory agencies in the US is known as a USDMF. Fazaclo ODT USDMF includes data on Fazaclo ODT's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fazaclo ODT USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fazaclo ODT 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 Fazaclo ODT Drug Master File in Japan (Fazaclo ODT JDMF) empowers Fazaclo ODT 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 Fazaclo ODT JDMF during the approval evaluation for pharmaceutical products. At the time of Fazaclo ODT 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 Fazaclo ODT 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 Fazaclo ODT Drug Master File in Korea (Fazaclo ODT KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fazaclo ODT. The MFDS reviews the Fazaclo ODT KDMF as part of the drug registration process and uses the information provided in the Fazaclo ODT KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fazaclo ODT 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 Fazaclo ODT API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fazaclo ODT suppliers with KDMF on PharmaCompass.
A Fazaclo ODT CEP of the European Pharmacopoeia monograph is often referred to as a Fazaclo ODT Certificate of Suitability (COS). The purpose of a Fazaclo ODT CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fazaclo ODT EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fazaclo ODT to their clients by showing that a Fazaclo ODT CEP has been issued for it. The manufacturer submits a Fazaclo ODT CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fazaclo ODT CEP holder for the record. Additionally, the data presented in the Fazaclo ODT CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fazaclo ODT DMF.
A Fazaclo ODT CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fazaclo ODT CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Fazaclo ODT suppliers with CEP (COS) on PharmaCompass.
A Fazaclo ODT written confirmation (Fazaclo ODT WC) is an official document issued by a regulatory agency to a Fazaclo ODT manufacturer, verifying that the manufacturing facility of a Fazaclo ODT active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fazaclo ODT APIs or Fazaclo ODT finished pharmaceutical products to another nation, regulatory agencies frequently require a Fazaclo ODT WC (written confirmation) as part of the regulatory process.
click here to find a list of Fazaclo ODT 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 Fazaclo ODT as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fazaclo ODT 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 Fazaclo ODT 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 Fazaclo ODT and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fazaclo ODT NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fazaclo ODT suppliers with NDC on PharmaCompass.
Fazaclo ODT 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 Fazaclo ODT 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 Fazaclo ODT GMP manufacturer or Fazaclo ODT GMP API supplier for your needs.
A Fazaclo ODT CoA (Certificate of Analysis) is a formal document that attests to Fazaclo ODT's compliance with Fazaclo ODT specifications and serves as a tool for batch-level quality control.
Fazaclo ODT CoA mostly includes findings from lab analyses of a specific batch. For each Fazaclo ODT 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.
Fazaclo ODT may be tested according to a variety of international standards, such as European Pharmacopoeia (Fazaclo ODT EP), Fazaclo ODT JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fazaclo ODT USP).
