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ABOUT THIS PAGE
A Magnesium Carbonate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Magnesium Carbonate, including repackagers and relabelers. The FDA regulates Magnesium Carbonate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Magnesium Carbonate 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 Magnesium Carbonate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Magnesium Carbonate supplier is an individual or a company that provides Magnesium Carbonate active pharmaceutical ingredient (API) or Magnesium Carbonate finished formulations upon request. The Magnesium Carbonate suppliers may include Magnesium Carbonate API manufacturers, exporters, distributors and traders.
click here to find a list of Magnesium Carbonate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Magnesium Carbonate DMF (Drug Master File) is a document detailing the whole manufacturing process of Magnesium Carbonate active pharmaceutical ingredient (API) in detail. Different forms of Magnesium Carbonate DMFs exist exist since differing nations have different regulations, such as Magnesium Carbonate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Magnesium Carbonate DMF submitted to regulatory agencies in the US is known as a USDMF. Magnesium Carbonate USDMF includes data on Magnesium Carbonate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Magnesium Carbonate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Magnesium Carbonate 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 Magnesium Carbonate Drug Master File in Japan (Magnesium Carbonate JDMF) empowers Magnesium Carbonate 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 Magnesium Carbonate JDMF during the approval evaluation for pharmaceutical products. At the time of Magnesium Carbonate 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 Magnesium Carbonate suppliers with JDMF on PharmaCompass.
A Magnesium Carbonate CEP of the European Pharmacopoeia monograph is often referred to as a Magnesium Carbonate Certificate of Suitability (COS). The purpose of a Magnesium Carbonate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Magnesium Carbonate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Magnesium Carbonate to their clients by showing that a Magnesium Carbonate CEP has been issued for it. The manufacturer submits a Magnesium Carbonate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Magnesium Carbonate CEP holder for the record. Additionally, the data presented in the Magnesium Carbonate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Magnesium Carbonate DMF.
A Magnesium Carbonate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Magnesium Carbonate 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 Magnesium Carbonate suppliers with CEP (COS) on PharmaCompass.
A Magnesium Carbonate written confirmation (Magnesium Carbonate WC) is an official document issued by a regulatory agency to a Magnesium Carbonate manufacturer, verifying that the manufacturing facility of a Magnesium Carbonate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Magnesium Carbonate APIs or Magnesium Carbonate finished pharmaceutical products to another nation, regulatory agencies frequently require a Magnesium Carbonate WC (written confirmation) as part of the regulatory process.
click here to find a list of Magnesium Carbonate 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 Magnesium Carbonate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Magnesium Carbonate 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 Magnesium Carbonate 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 Magnesium Carbonate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Magnesium Carbonate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Magnesium Carbonate suppliers with NDC on PharmaCompass.
Magnesium Carbonate 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 Magnesium Carbonate 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 Magnesium Carbonate GMP manufacturer or Magnesium Carbonate GMP API supplier for your needs.
A Magnesium Carbonate CoA (Certificate of Analysis) is a formal document that attests to Magnesium Carbonate's compliance with Magnesium Carbonate specifications and serves as a tool for batch-level quality control.
Magnesium Carbonate CoA mostly includes findings from lab analyses of a specific batch. For each Magnesium Carbonate 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.
Magnesium Carbonate may be tested according to a variety of international standards, such as European Pharmacopoeia (Magnesium Carbonate EP), Magnesium Carbonate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Magnesium Carbonate USP).
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