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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...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
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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- 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
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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 Seawater magnesia manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Seawater magnesia, including repackagers and relabelers. The FDA regulates Seawater magnesia manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Seawater magnesia 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 Seawater magnesia manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Seawater magnesia supplier is an individual or a company that provides Seawater magnesia active pharmaceutical ingredient (API) or Seawater magnesia finished formulations upon request. The Seawater magnesia suppliers may include Seawater magnesia API manufacturers, exporters, distributors and traders.
click here to find a list of Seawater magnesia suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Seawater magnesia DMF (Drug Master File) is a document detailing the whole manufacturing process of Seawater magnesia active pharmaceutical ingredient (API) in detail. Different forms of Seawater magnesia DMFs exist exist since differing nations have different regulations, such as Seawater magnesia USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Seawater magnesia DMF submitted to regulatory agencies in the US is known as a USDMF. Seawater magnesia USDMF includes data on Seawater magnesia's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Seawater magnesia USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Seawater magnesia 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 Seawater magnesia Drug Master File in Japan (Seawater magnesia JDMF) empowers Seawater magnesia 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 Seawater magnesia JDMF during the approval evaluation for pharmaceutical products. At the time of Seawater magnesia 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 Seawater magnesia 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 Seawater magnesia Drug Master File in Korea (Seawater magnesia KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Seawater magnesia. The MFDS reviews the Seawater magnesia KDMF as part of the drug registration process and uses the information provided in the Seawater magnesia KDMF to evaluate the safety and efficacy of the drug.
After submitting a Seawater magnesia 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 Seawater magnesia API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Seawater magnesia suppliers with KDMF on PharmaCompass.
A Seawater magnesia CEP of the European Pharmacopoeia monograph is often referred to as a Seawater magnesia Certificate of Suitability (COS). The purpose of a Seawater magnesia CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Seawater magnesia EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Seawater magnesia to their clients by showing that a Seawater magnesia CEP has been issued for it. The manufacturer submits a Seawater magnesia CEP (COS) as part of the market authorization procedure, and it takes on the role of a Seawater magnesia CEP holder for the record. Additionally, the data presented in the Seawater magnesia CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Seawater magnesia DMF.
A Seawater magnesia CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Seawater magnesia 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 Seawater magnesia 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 Seawater magnesia as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Seawater magnesia 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 Seawater magnesia 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 Seawater magnesia and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Seawater magnesia NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Seawater magnesia suppliers with NDC on PharmaCompass.
Seawater magnesia 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 Seawater magnesia 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 Seawater magnesia GMP manufacturer or Seawater magnesia GMP API supplier for your needs.
A Seawater magnesia CoA (Certificate of Analysis) is a formal document that attests to Seawater magnesia's compliance with Seawater magnesia specifications and serves as a tool for batch-level quality control.
Seawater magnesia CoA mostly includes findings from lab analyses of a specific batch. For each Seawater magnesia 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.
Seawater magnesia may be tested according to a variety of international standards, such as European Pharmacopoeia (Seawater magnesia EP), Seawater magnesia JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Seawater magnesia USP).
