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API SUPPLIERS
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USDMF
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Withdrawn
Registration Country : Malta
Aluminium Hydroxide; Magnesium Hydroxide
Brand Name : Maalox Aluminium Hydroxide/Magnesium Hydroxide For Stomach Relief Berry Oral
Dosage Form : Oral Suspension
Dosage Strength : 460MG; 400MG
Packaging :
Approval Date : 2014-03-17
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Withdrawn
Registration Country : Malta
Magnesium Hydroxide; Aluminium Hydroxide
Brand Name : Maalox Stomach Ache Aluminium Hydroxide/ Magnesium Hydroxide
Dosage Form : Oral Suspension
Dosage Strength : 400MG; 460MG
Packaging :
Approval Date : 2020-04-22
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Cancelled
Registration Country : Spain
Magnesium Hydroxide; Aluminum Hydroxide
Brand Name : Maalox
Dosage Form : Chewable Tablet
Dosage Strength : 400MG; 400 MG
Packaging :
Approval Date : 05-06-2017
Application Number : 82114
Regulatory Info : Cancelled
Registration Country : Spain
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Cancelled
Registration Country : Spain
Magnesium Hydroxide; Aluminum Hydroxide
Brand Name : Maalox
Dosage Form : Oral Suspension In Envelope
Dosage Strength : 460MG; 400 MG
Packaging :
Approval Date : 05-06-2017
Application Number : 82113
Regulatory Info : Cancelled
Registration Country : Spain
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ABOUT THIS PAGE
58
PharmaCompass offers a list of Aluminium Hydroxide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Aluminium Hydroxide manufacturer or Aluminium Hydroxide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Aluminium Hydroxide manufacturer or Aluminium Hydroxide supplier.
A Aluminum hydroxide, dried manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aluminum hydroxide, dried, including repackagers and relabelers. The FDA regulates Aluminum hydroxide, dried manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aluminum hydroxide, dried 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 Aluminum hydroxide, dried manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Aluminum hydroxide, dried supplier is an individual or a company that provides Aluminum hydroxide, dried active pharmaceutical ingredient (API) or Aluminum hydroxide, dried finished formulations upon request. The Aluminum hydroxide, dried suppliers may include Aluminum hydroxide, dried API manufacturers, exporters, distributors and traders.
click here to find a list of Aluminum hydroxide, dried suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Aluminum hydroxide, dried DMF (Drug Master File) is a document detailing the whole manufacturing process of Aluminum hydroxide, dried active pharmaceutical ingredient (API) in detail. Different forms of Aluminum hydroxide, dried DMFs exist exist since differing nations have different regulations, such as Aluminum hydroxide, dried USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aluminum hydroxide, dried DMF submitted to regulatory agencies in the US is known as a USDMF. Aluminum hydroxide, dried USDMF includes data on Aluminum hydroxide, dried's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aluminum hydroxide, dried USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aluminum hydroxide, dried 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 Aluminum hydroxide, dried Drug Master File in Japan (Aluminum hydroxide, dried JDMF) empowers Aluminum hydroxide, dried 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 Aluminum hydroxide, dried JDMF during the approval evaluation for pharmaceutical products. At the time of Aluminum hydroxide, dried 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 Aluminum hydroxide, dried suppliers with JDMF on PharmaCompass.
A Aluminum hydroxide, dried written confirmation (Aluminum hydroxide, dried WC) is an official document issued by a regulatory agency to a Aluminum hydroxide, dried manufacturer, verifying that the manufacturing facility of a Aluminum hydroxide, dried active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Aluminum hydroxide, dried APIs or Aluminum hydroxide, dried finished pharmaceutical products to another nation, regulatory agencies frequently require a Aluminum hydroxide, dried WC (written confirmation) as part of the regulatory process.
click here to find a list of Aluminum hydroxide, dried 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 Aluminum hydroxide, dried as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aluminum hydroxide, dried 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 Aluminum hydroxide, dried 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 Aluminum hydroxide, dried and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aluminum hydroxide, dried NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Aluminum hydroxide, dried suppliers with NDC on PharmaCompass.
Aluminum hydroxide, dried 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 Aluminum hydroxide, dried GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Aluminum hydroxide, dried GMP manufacturer or Aluminum hydroxide, dried GMP API supplier for your needs.
A Aluminum hydroxide, dried CoA (Certificate of Analysis) is a formal document that attests to Aluminum hydroxide, dried's compliance with Aluminum hydroxide, dried specifications and serves as a tool for batch-level quality control.
Aluminum hydroxide, dried CoA mostly includes findings from lab analyses of a specific batch. For each Aluminum hydroxide, dried 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.
Aluminum hydroxide, dried may be tested according to a variety of international standards, such as European Pharmacopoeia (Aluminum hydroxide, dried EP), Aluminum hydroxide, dried JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aluminum hydroxide, dried USP).
