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