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
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PharmaCompass offers a list of Pefcalcitol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Pefcalcitol manufacturer or Pefcalcitol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pefcalcitol manufacturer or Pefcalcitol supplier.
PharmaCompass also assists you with knowing the Pefcalcitol API Price utilized in the formulation of products. Pefcalcitol API Price is not always fixed or binding as the Pefcalcitol Price is obtained through a variety of data sources. The Pefcalcitol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
