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