01 1CordenPharma
02 1NOF CORPORATION
01 1Germany
02 1Japan
01 2Active
01 2Blank
01 2Blank
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20474
Submission : 2007-04-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12233
Submission : 1996-11-22
Status : Active
Type : IV
A DSPG manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DSPG, including repackagers and relabelers. The FDA regulates DSPG manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DSPG 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 DSPG supplier is an individual or a company that provides DSPG active pharmaceutical ingredient (API) or DSPG finished formulations upon request. The DSPG suppliers may include DSPG API manufacturers, exporters, distributors and traders.
click here to find a list of DSPG suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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