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01 1Evonik
01 1100 DL MPEG 5000
01 1Germany
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26897
Submission : 2013-02-13
Status : Active
Type : IV
A MPEG2000-DSPE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MPEG2000-DSPE, including repackagers and relabelers. The FDA regulates MPEG2000-DSPE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MPEG2000-DSPE 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 MPEG2000-DSPE supplier is an individual or a company that provides MPEG2000-DSPE active pharmaceutical ingredient (API) or MPEG2000-DSPE finished formulations upon request. The MPEG2000-DSPE suppliers may include MPEG2000-DSPE API manufacturers, exporters, distributors and traders.
click here to find a list of MPEG2000-DSPE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A MPEG2000-DSPE DMF (Drug Master File) is a document detailing the whole manufacturing process of MPEG2000-DSPE active pharmaceutical ingredient (API) in detail. Different forms of MPEG2000-DSPE DMFs exist exist since differing nations have different regulations, such as MPEG2000-DSPE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MPEG2000-DSPE DMF submitted to regulatory agencies in the US is known as a USDMF. MPEG2000-DSPE USDMF includes data on MPEG2000-DSPE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MPEG2000-DSPE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of MPEG2000-DSPE suppliers with USDMF on PharmaCompass.
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