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CEP/COS
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EU WC
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US Medicaid
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API SUPPLIERS
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ABOUT THIS PAGE
A Aluminum Magnesium Silicate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aluminum Magnesium Silicate, including repackagers and relabelers. The FDA regulates Aluminum Magnesium Silicate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aluminum Magnesium Silicate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Aluminum Magnesium Silicate supplier is an individual or a company that provides Aluminum Magnesium Silicate active pharmaceutical ingredient (API) or Aluminum Magnesium Silicate finished formulations upon request. The Aluminum Magnesium Silicate suppliers may include Aluminum Magnesium Silicate API manufacturers, exporters, distributors and traders.
click here to find a list of Aluminum Magnesium Silicate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aluminum Magnesium Silicate DMF (Drug Master File) is a document detailing the whole manufacturing process of Aluminum Magnesium Silicate active pharmaceutical ingredient (API) in detail. Different forms of Aluminum Magnesium Silicate DMFs exist exist since differing nations have different regulations, such as Aluminum Magnesium Silicate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aluminum Magnesium Silicate DMF submitted to regulatory agencies in the US is known as a USDMF. Aluminum Magnesium Silicate USDMF includes data on Aluminum Magnesium Silicate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aluminum Magnesium Silicate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aluminum Magnesium Silicate 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 Magnesium Silicate Drug Master File in Japan (Aluminum Magnesium Silicate JDMF) empowers Aluminum Magnesium Silicate 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 Magnesium Silicate JDMF during the approval evaluation for pharmaceutical products. At the time of Aluminum Magnesium Silicate 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 Magnesium Silicate suppliers with JDMF on PharmaCompass.
Aluminum Magnesium Silicate 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 Magnesium Silicate 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 Aluminum Magnesium Silicate GMP manufacturer or Aluminum Magnesium Silicate GMP API supplier for your needs.
A Aluminum Magnesium Silicate CoA (Certificate of Analysis) is a formal document that attests to Aluminum Magnesium Silicate's compliance with Aluminum Magnesium Silicate specifications and serves as a tool for batch-level quality control.
Aluminum Magnesium Silicate CoA mostly includes findings from lab analyses of a specific batch. For each Aluminum Magnesium Silicate 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 Magnesium Silicate may be tested according to a variety of international standards, such as European Pharmacopoeia (Aluminum Magnesium Silicate EP), Aluminum Magnesium Silicate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aluminum Magnesium Silicate USP).
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