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API SUPPLIERS
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USDMF
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12 Mar 2020
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ABOUT THIS PAGE
A DSPC manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DSPC, including repackagers and relabelers. The FDA regulates DSPC manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DSPC 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 DSPC supplier is an individual or a company that provides DSPC active pharmaceutical ingredient (API) or DSPC finished formulations upon request. The DSPC suppliers may include DSPC API manufacturers, exporters, distributors and traders.
click here to find a list of DSPC suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DSPC DMF (Drug Master File) is a document detailing the whole manufacturing process of DSPC active pharmaceutical ingredient (API) in detail. Different forms of DSPC DMFs exist exist since differing nations have different regulations, such as DSPC USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DSPC DMF submitted to regulatory agencies in the US is known as a USDMF. DSPC USDMF includes data on DSPC's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DSPC USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DSPC suppliers with USDMF on PharmaCompass.
DSPC 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 DSPC 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 DSPC GMP manufacturer or DSPC GMP API supplier for your needs.
A DSPC CoA (Certificate of Analysis) is a formal document that attests to DSPC's compliance with DSPC specifications and serves as a tool for batch-level quality control.
DSPC CoA mostly includes findings from lab analyses of a specific batch. For each DSPC 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.
DSPC may be tested according to a variety of international standards, such as European Pharmacopoeia (DSPC EP), DSPC JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DSPC USP).
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