Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - EQ 100MG BASE
USFDA APPLICATION NUMBER - 20639
DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20639
DOSAGE - TABLET;ORAL - EQ 200MG BASE
USFDA APPLICATION NUMBER - 20639
DOSAGE - TABLET;ORAL - EQ 25MG BASE
USFDA APPLICATION NUMBER - 20639
DOSAGE - TABLET;ORAL - EQ 300MG BASE
USFDA APPLICATION NUMBER - 20639
DOSAGE - TABLET;ORAL - EQ 400MG BASE
USFDA APPLICATION NUMBER - 20639
DOSAGE - TABLET;ORAL - EQ 50MG BASE
USFDA APPLICATION NUMBER - 20639
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE
USFDA APPLICATION NUMBER - 22047
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE
USFDA APPLICATION NUMBER - 22047
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 3...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 300MG BASE
USFDA APPLICATION NUMBER - 22047
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 4...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 400MG BASE
USFDA APPLICATION NUMBER - 22047
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE
USFDA APPLICATION NUMBER - 22047
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
30
PharmaCompass offers a list of Quetiapine Hemifumarate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Quetiapine Hemifumarate manufacturer or Quetiapine Hemifumarate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Quetiapine Hemifumarate manufacturer or Quetiapine Hemifumarate supplier.
A Quetiapine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Quetiapine, including repackagers and relabelers. The FDA regulates Quetiapine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Quetiapine 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 Quetiapine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Quetiapine supplier is an individual or a company that provides Quetiapine active pharmaceutical ingredient (API) or Quetiapine finished formulations upon request. The Quetiapine suppliers may include Quetiapine API manufacturers, exporters, distributors and traders.
click here to find a list of Quetiapine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Quetiapine DMF (Drug Master File) is a document detailing the whole manufacturing process of Quetiapine active pharmaceutical ingredient (API) in detail. Different forms of Quetiapine DMFs exist exist since differing nations have different regulations, such as Quetiapine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Quetiapine DMF submitted to regulatory agencies in the US is known as a USDMF. Quetiapine USDMF includes data on Quetiapine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Quetiapine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Quetiapine 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 Quetiapine Drug Master File in Japan (Quetiapine JDMF) empowers Quetiapine 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 Quetiapine JDMF during the approval evaluation for pharmaceutical products. At the time of Quetiapine 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 Quetiapine 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 Quetiapine Drug Master File in Korea (Quetiapine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Quetiapine. The MFDS reviews the Quetiapine KDMF as part of the drug registration process and uses the information provided in the Quetiapine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Quetiapine 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 Quetiapine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Quetiapine suppliers with KDMF on PharmaCompass.
A Quetiapine CEP of the European Pharmacopoeia monograph is often referred to as a Quetiapine Certificate of Suitability (COS). The purpose of a Quetiapine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Quetiapine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Quetiapine to their clients by showing that a Quetiapine CEP has been issued for it. The manufacturer submits a Quetiapine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Quetiapine CEP holder for the record. Additionally, the data presented in the Quetiapine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Quetiapine DMF.
A Quetiapine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Quetiapine 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 Quetiapine suppliers with CEP (COS) on PharmaCompass.
A Quetiapine written confirmation (Quetiapine WC) is an official document issued by a regulatory agency to a Quetiapine manufacturer, verifying that the manufacturing facility of a Quetiapine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Quetiapine APIs or Quetiapine finished pharmaceutical products to another nation, regulatory agencies frequently require a Quetiapine WC (written confirmation) as part of the regulatory process.
click here to find a list of Quetiapine 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 Quetiapine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Quetiapine 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 Quetiapine 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 Quetiapine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Quetiapine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Quetiapine suppliers with NDC on PharmaCompass.
Quetiapine 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 Quetiapine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Quetiapine GMP manufacturer or Quetiapine GMP API supplier for your needs.
A Quetiapine CoA (Certificate of Analysis) is a formal document that attests to Quetiapine's compliance with Quetiapine specifications and serves as a tool for batch-level quality control.
Quetiapine CoA mostly includes findings from lab analyses of a specific batch. For each Quetiapine 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.
Quetiapine may be tested according to a variety of international standards, such as European Pharmacopoeia (Quetiapine EP), Quetiapine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Quetiapine USP).
