01 1Chugai Pharmaceutical
01 1OCT (MAXACALCITOL)
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12918
Submission : 1998-03-26
Status : Inactive
Type : II
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PharmaCompass offers a list of Maxacalcitol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Maxacalcitol manufacturer or Maxacalcitol supplier for your needs.
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A Maxacalcitol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Maxacalcitol, including repackagers and relabelers. The FDA regulates Maxacalcitol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Maxacalcitol 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 Maxacalcitol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Maxacalcitol supplier is an individual or a company that provides Maxacalcitol active pharmaceutical ingredient (API) or Maxacalcitol finished formulations upon request. The Maxacalcitol suppliers may include Maxacalcitol API manufacturers, exporters, distributors and traders.
click here to find a list of Maxacalcitol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Maxacalcitol DMF (Drug Master File) is a document detailing the whole manufacturing process of Maxacalcitol active pharmaceutical ingredient (API) in detail. Different forms of Maxacalcitol DMFs exist exist since differing nations have different regulations, such as Maxacalcitol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Maxacalcitol DMF submitted to regulatory agencies in the US is known as a USDMF. Maxacalcitol USDMF includes data on Maxacalcitol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Maxacalcitol USDMF is kept confidential to protect the manufacturer’s intellectual property.
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