US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Metamizole 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 Metamizole manufacturer or Metamizole supplier for your needs.
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PharmaCompass also assists you with knowing the Metamizole API Price utilized in the formulation of products. Metamizole API Price is not always fixed or binding as the Metamizole Price is obtained through a variety of data sources. The Metamizole Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Metamizole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Metamizole, including repackagers and relabelers. The FDA regulates Metamizole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Metamizole API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Metamizole supplier is an individual or a company that provides Metamizole active pharmaceutical ingredient (API) or Metamizole finished formulations upon request. The Metamizole suppliers may include Metamizole API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Metamizole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Metamizole DMF (Drug Master File) is a document detailing the whole manufacturing process of Metamizole active pharmaceutical ingredient (API) in detail. Different forms of Metamizole DMFs exist exist since differing nations have different regulations, such as Metamizole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Metamizole DMF submitted to regulatory agencies in the US is known as a USDMF. Metamizole USDMF includes data on Metamizole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Metamizole USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Metamizole Drug Master File in Japan (Metamizole JDMF) empowers Metamizole 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 Metamizole JDMF during the approval evaluation for pharmaceutical products. At the time of Metamizole JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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A Metamizole CEP of the European Pharmacopoeia monograph is often referred to as a Metamizole Certificate of Suitability (COS). The purpose of a Metamizole CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Metamizole EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Metamizole to their clients by showing that a Metamizole CEP has been issued for it. The manufacturer submits a Metamizole CEP (COS) as part of the market authorization procedure, and it takes on the role of a Metamizole CEP holder for the record. Additionally, the data presented in the Metamizole CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Metamizole DMF.
A Metamizole CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Metamizole CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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Metamizole 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 Metamizole 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 Metamizole GMP manufacturer or Metamizole GMP API supplier for your needs.
A Metamizole CoA (Certificate of Analysis) is a formal document that attests to Metamizole's compliance with Metamizole specifications and serves as a tool for batch-level quality control.
Metamizole CoA mostly includes findings from lab analyses of a specific batch. For each Metamizole 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.
Metamizole may be tested according to a variety of international standards, such as European Pharmacopoeia (Metamizole EP), Metamizole JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Metamizole USP).