Synopsis
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JDMF
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EU WC
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KDMF
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FDF
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US Medicaid
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API SUPPLIERS
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USDMF
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DATA COMPILATION #PharmaFlow
Market Place
REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
A Alpha-D-Galactose manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alpha-D-Galactose, including repackagers and relabelers. The FDA regulates Alpha-D-Galactose manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alpha-D-Galactose 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 Alpha-D-Galactose manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alpha-D-Galactose supplier is an individual or a company that provides Alpha-D-Galactose active pharmaceutical ingredient (API) or Alpha-D-Galactose finished formulations upon request. The Alpha-D-Galactose suppliers may include Alpha-D-Galactose API manufacturers, exporters, distributors and traders.
click here to find a list of Alpha-D-Galactose suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alpha-D-Galactose DMF (Drug Master File) is a document detailing the whole manufacturing process of Alpha-D-Galactose active pharmaceutical ingredient (API) in detail. Different forms of Alpha-D-Galactose DMFs exist exist since differing nations have different regulations, such as Alpha-D-Galactose USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alpha-D-Galactose DMF submitted to regulatory agencies in the US is known as a USDMF. Alpha-D-Galactose USDMF includes data on Alpha-D-Galactose's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alpha-D-Galactose USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alpha-D-Galactose suppliers with USDMF on PharmaCompass.
A Alpha-D-Galactose CEP of the European Pharmacopoeia monograph is often referred to as a Alpha-D-Galactose Certificate of Suitability (COS). The purpose of a Alpha-D-Galactose CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Alpha-D-Galactose EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Alpha-D-Galactose to their clients by showing that a Alpha-D-Galactose CEP has been issued for it. The manufacturer submits a Alpha-D-Galactose CEP (COS) as part of the market authorization procedure, and it takes on the role of a Alpha-D-Galactose CEP holder for the record. Additionally, the data presented in the Alpha-D-Galactose CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Alpha-D-Galactose DMF.
A Alpha-D-Galactose CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Alpha-D-Galactose CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Alpha-D-Galactose suppliers with CEP (COS) on PharmaCompass.
Alpha-D-Galactose 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 Alpha-D-Galactose 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 Alpha-D-Galactose GMP manufacturer or Alpha-D-Galactose GMP API supplier for your needs.
A Alpha-D-Galactose CoA (Certificate of Analysis) is a formal document that attests to Alpha-D-Galactose's compliance with Alpha-D-Galactose specifications and serves as a tool for batch-level quality control.
Alpha-D-Galactose CoA mostly includes findings from lab analyses of a specific batch. For each Alpha-D-Galactose 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.
Alpha-D-Galactose may be tested according to a variety of international standards, such as European Pharmacopoeia (Alpha-D-Galactose EP), Alpha-D-Galactose JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alpha-D-Galactose USP).
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