01 1ALP Pharm
01 1ELOCALCITOL
01 1China
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22279
Submission : 2008-12-02
Status : Inactive
Type : II
A Elocalcitol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elocalcitol, including repackagers and relabelers. The FDA regulates Elocalcitol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elocalcitol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Elocalcitol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Elocalcitol supplier is an individual or a company that provides Elocalcitol active pharmaceutical ingredient (API) or Elocalcitol finished formulations upon request. The Elocalcitol suppliers may include Elocalcitol API manufacturers, exporters, distributors and traders.
click here to find a list of Elocalcitol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Elocalcitol DMF (Drug Master File) is a document detailing the whole manufacturing process of Elocalcitol active pharmaceutical ingredient (API) in detail. Different forms of Elocalcitol DMFs exist exist since differing nations have different regulations, such as Elocalcitol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Elocalcitol DMF submitted to regulatory agencies in the US is known as a USDMF. Elocalcitol USDMF includes data on Elocalcitol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Elocalcitol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Elocalcitol suppliers with USDMF on PharmaCompass.
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