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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- 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
57
PharmaCompass offers a list of Magnesium Oxide 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 Oxide manufacturer or Magnesium Oxide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Magnesium Oxide manufacturer or Magnesium Oxide supplier.
PharmaCompass also assists you with knowing the Magnesium Oxide API Price utilized in the formulation of products. Magnesium Oxide API Price is not always fixed or binding as the Magnesium Oxide Price is obtained through a variety of data sources. The Magnesium Oxide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A E530 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of E530, including repackagers and relabelers. The FDA regulates E530 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. E530 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 E530 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A E530 supplier is an individual or a company that provides E530 active pharmaceutical ingredient (API) or E530 finished formulations upon request. The E530 suppliers may include E530 API manufacturers, exporters, distributors and traders.
click here to find a list of E530 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A E530 DMF (Drug Master File) is a document detailing the whole manufacturing process of E530 active pharmaceutical ingredient (API) in detail. Different forms of E530 DMFs exist exist since differing nations have different regulations, such as E530 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A E530 DMF submitted to regulatory agencies in the US is known as a USDMF. E530 USDMF includes data on E530's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The E530 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of E530 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 E530 Drug Master File in Japan (E530 JDMF) empowers E530 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 E530 JDMF during the approval evaluation for pharmaceutical products. At the time of E530 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 E530 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 E530 Drug Master File in Korea (E530 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of E530. The MFDS reviews the E530 KDMF as part of the drug registration process and uses the information provided in the E530 KDMF to evaluate the safety and efficacy of the drug.
After submitting a E530 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 E530 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of E530 suppliers with KDMF on PharmaCompass.
A E530 CEP of the European Pharmacopoeia monograph is often referred to as a E530 Certificate of Suitability (COS). The purpose of a E530 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of E530 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of E530 to their clients by showing that a E530 CEP has been issued for it. The manufacturer submits a E530 CEP (COS) as part of the market authorization procedure, and it takes on the role of a E530 CEP holder for the record. Additionally, the data presented in the E530 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the E530 DMF.
A E530 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. E530 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 E530 suppliers with CEP (COS) 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 E530 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for E530 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 E530 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 E530 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a E530 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of E530 suppliers with NDC on PharmaCompass.
E530 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 E530 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 E530 GMP manufacturer or E530 GMP API supplier for your needs.
A E530 CoA (Certificate of Analysis) is a formal document that attests to E530's compliance with E530 specifications and serves as a tool for batch-level quality control.
E530 CoA mostly includes findings from lab analyses of a specific batch. For each E530 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.
E530 may be tested according to a variety of international standards, such as European Pharmacopoeia (E530 EP), E530 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (E530 USP).
