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1. 1317-26-6
2. Aluminum Hydroxide/magnesium Hydroxide
3. Aluminum Hydroxide/magnesium Hydroxide - Magaldrate C410
4. Aluminum Hydroxide/magnesium Hydroxide - Magaldrate C632
Molecular Weight | 86.310 g/mol |
---|---|
Molecular Formula | AlH3MgO2- |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 2 |
Rotatable Bond Count | 0 |
Exact Mass | 85.9798844 g/mol |
Monoisotopic Mass | 85.9798844 g/mol |
Topological Polar Surface Area | 2 Ų |
Heavy Atom Count | 4 |
Formal Charge | -1 |
Complexity | 0 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 4 |
A02AD02
S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39249
Submission : 2023-12-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30140
Submission : 2015-12-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25272
Submission : 2011-02-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9016
Submission : 1991-03-12
Status : Inactive
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-02-07
Written Confirmation Number : WC-0187
Address of the Firm : S.V. Co-operative Industrial Estate, IDA, Bollaram, Bollaram (V), Jinnaram (M), ...
NDC Package Code : 12784-204
Start Marketing Date : 2014-06-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (98kg/100kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 12784-205
Start Marketing Date : 2020-01-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (98kg/100kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 55603-170
Start Marketing Date : 2013-11-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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PharmaCompass offers a list of Magaldrate 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 Magaldrate manufacturer or Magaldrate supplier for your needs.
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A Magmed manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Magmed, including repackagers and relabelers. The FDA regulates Magmed manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Magmed 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 Magmed manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Magmed supplier is an individual or a company that provides Magmed active pharmaceutical ingredient (API) or Magmed finished formulations upon request. The Magmed suppliers may include Magmed API manufacturers, exporters, distributors and traders.
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A Magmed DMF (Drug Master File) is a document detailing the whole manufacturing process of Magmed active pharmaceutical ingredient (API) in detail. Different forms of Magmed DMFs exist exist since differing nations have different regulations, such as Magmed USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Magmed DMF submitted to regulatory agencies in the US is known as a USDMF. Magmed USDMF includes data on Magmed's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Magmed USDMF is kept confidential to protect the manufacturer’s intellectual property.
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A Magmed written confirmation (Magmed WC) is an official document issued by a regulatory agency to a Magmed manufacturer, verifying that the manufacturing facility of a Magmed active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Magmed APIs or Magmed finished pharmaceutical products to another nation, regulatory agencies frequently require a Magmed WC (written confirmation) as part of the regulatory process.
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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 Magmed as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Magmed 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 Magmed 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 Magmed and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Magmed NDC to their finished compounded human drug products, they may choose to do so.
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Magmed 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 Magmed 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 Magmed GMP manufacturer or Magmed GMP API supplier for your needs.
A Magmed CoA (Certificate of Analysis) is a formal document that attests to Magmed's compliance with Magmed specifications and serves as a tool for batch-level quality control.
Magmed CoA mostly includes findings from lab analyses of a specific batch. For each Magmed 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.
Magmed may be tested according to a variety of international standards, such as European Pharmacopoeia (Magmed EP), Magmed JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Magmed USP).