01 1SAFC
01 1PEFCALCITOL
01 1U.S.A
01 1Inactive
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.
A Pefcalcitol DMF (Drug Master File) is a document detailing the whole manufacturing process of Pefcalcitol active pharmaceutical ingredient (API) in detail. Different forms of Pefcalcitol DMFs exist exist since differing nations have different regulations, such as Pefcalcitol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pefcalcitol DMF submitted to regulatory agencies in the US is known as a USDMF. Pefcalcitol USDMF includes data on Pefcalcitol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pefcalcitol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pefcalcitol suppliers with USDMF on PharmaCompass.
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