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ABOUT THIS PAGE
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PharmaCompass offers a list of Aluminum Magnesium Silicate 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 Aluminum Magnesium Silicate manufacturer or Aluminum Magnesium Silicate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Aluminum Magnesium Silicate manufacturer or Aluminum Magnesium Silicate supplier.
PharmaCompass also assists you with knowing the Aluminum Magnesium Silicate API Price utilized in the formulation of products. Aluminum Magnesium Silicate API Price is not always fixed or binding as the Aluminum Magnesium Silicate Price is obtained through a variety of data sources. The Aluminum Magnesium Silicate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Malinal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Malinal, including repackagers and relabelers. The FDA regulates Malinal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Malinal 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 Malinal supplier is an individual or a company that provides Malinal active pharmaceutical ingredient (API) or Malinal finished formulations upon request. The Malinal suppliers may include Malinal API manufacturers, exporters, distributors and traders.
click here to find a list of Malinal suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Malinal DMF (Drug Master File) is a document detailing the whole manufacturing process of Malinal active pharmaceutical ingredient (API) in detail. Different forms of Malinal DMFs exist exist since differing nations have different regulations, such as Malinal USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Malinal DMF submitted to regulatory agencies in the US is known as a USDMF. Malinal USDMF includes data on Malinal's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Malinal USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Malinal 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 Malinal Drug Master File in Japan (Malinal JDMF) empowers Malinal 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 Malinal JDMF during the approval evaluation for pharmaceutical products. At the time of Malinal 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 Malinal suppliers with JDMF on PharmaCompass.
Malinal 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 Malinal 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 Malinal GMP manufacturer or Malinal GMP API supplier for your needs.
A Malinal CoA (Certificate of Analysis) is a formal document that attests to Malinal's compliance with Malinal specifications and serves as a tool for batch-level quality control.
Malinal CoA mostly includes findings from lab analyses of a specific batch. For each Malinal 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.
Malinal may be tested according to a variety of international standards, such as European Pharmacopoeia (Malinal EP), Malinal JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Malinal USP).
