01 1SAFC
01 1U.S.A
01 1Inactive
01 1Blank
01 1Blank
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30202
Submission : 2016-01-18
Status : Inactive
Type : II
A Pefcalcitol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pefcalcitol, including repackagers and relabelers. The FDA regulates Pefcalcitol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pefcalcitol 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 Pefcalcitol supplier is an individual or a company that provides Pefcalcitol active pharmaceutical ingredient (API) or Pefcalcitol finished formulations upon request. The Pefcalcitol suppliers may include Pefcalcitol API manufacturers, exporters, distributors and traders.
click here to find a list of Pefcalcitol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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