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Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
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USDMF
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Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...
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DOSAGE - FOR SOLUTION;ORAL - 12GM/PACKET;3.5G...DOSAGE - FOR SOLUTION;ORAL - 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 202535
DOSAGE - SOLUTION;ORAL - 12GM/BOT;3.5GM/BOT;1...DOSAGE - SOLUTION;ORAL - 12GM/BOT;3.5GM/BOT;10MG/BOT
USFDA APPLICATION NUMBER - 209589
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ABOUT THIS PAGE
A Magnesium Oxide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Magnesium Oxide, including repackagers and relabelers. The FDA regulates Magnesium Oxide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Magnesium Oxide 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 Oxide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Magnesium Oxide supplier is an individual or a company that provides Magnesium Oxide active pharmaceutical ingredient (API) or Magnesium Oxide finished formulations upon request. The Magnesium Oxide suppliers may include Magnesium Oxide API manufacturers, exporters, distributors and traders.
click here to find a list of Magnesium Oxide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Magnesium Oxide DMF (Drug Master File) is a document detailing the whole manufacturing process of Magnesium Oxide active pharmaceutical ingredient (API) in detail. Different forms of Magnesium Oxide DMFs exist exist since differing nations have different regulations, such as Magnesium Oxide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Magnesium Oxide DMF submitted to regulatory agencies in the US is known as a USDMF. Magnesium Oxide USDMF includes data on Magnesium Oxide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Magnesium Oxide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Magnesium Oxide 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 Oxide Drug Master File in Japan (Magnesium Oxide JDMF) empowers Magnesium Oxide 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 Oxide JDMF during the approval evaluation for pharmaceutical products. At the time of Magnesium Oxide 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 Oxide 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 Magnesium Oxide Drug Master File in Korea (Magnesium Oxide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Magnesium Oxide. The MFDS reviews the Magnesium Oxide KDMF as part of the drug registration process and uses the information provided in the Magnesium Oxide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Magnesium Oxide 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 Magnesium Oxide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Magnesium Oxide suppliers with KDMF on PharmaCompass.
A Magnesium Oxide CEP of the European Pharmacopoeia monograph is often referred to as a Magnesium Oxide Certificate of Suitability (COS). The purpose of a Magnesium Oxide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Magnesium Oxide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Magnesium Oxide to their clients by showing that a Magnesium Oxide CEP has been issued for it. The manufacturer submits a Magnesium Oxide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Magnesium Oxide CEP holder for the record. Additionally, the data presented in the Magnesium Oxide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Magnesium Oxide DMF.
A Magnesium Oxide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Magnesium Oxide 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 Oxide suppliers with CEP (COS) on PharmaCompass.
A Magnesium Oxide written confirmation (Magnesium Oxide WC) is an official document issued by a regulatory agency to a Magnesium Oxide manufacturer, verifying that the manufacturing facility of a Magnesium Oxide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Magnesium Oxide APIs or Magnesium Oxide finished pharmaceutical products to another nation, regulatory agencies frequently require a Magnesium Oxide WC (written confirmation) as part of the regulatory process.
click here to find a list of Magnesium Oxide 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 Oxide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Magnesium Oxide 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 Oxide 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 Oxide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Magnesium Oxide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Magnesium Oxide suppliers with NDC on PharmaCompass.
Magnesium Oxide 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 Oxide 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 Oxide GMP manufacturer or Magnesium Oxide GMP API supplier for your needs.
A Magnesium Oxide CoA (Certificate of Analysis) is a formal document that attests to Magnesium Oxide's compliance with Magnesium Oxide specifications and serves as a tool for batch-level quality control.
Magnesium Oxide CoA mostly includes findings from lab analyses of a specific batch. For each Magnesium Oxide 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 Oxide may be tested according to a variety of international standards, such as European Pharmacopoeia (Magnesium Oxide EP), Magnesium Oxide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Magnesium Oxide USP).
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