01 1Catalent Pharma Solutions
02 1DISHMAN NETHERLANDS B.V.
03 1Formosa Laboratories
04 1SOLVAY -Technology Solutions
01 3CALCIFEDIOL
02 1CALDEROL SOFTGELS 20MCG
01 1Germany
02 1Netherlands
03 1Taiwan
04 1U.S.A
01 2Active
02 2Inactive
01 1Complete
02 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15564
Submission : 2001-08-02
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-28
Pay. Date : 2016-07-08
DMF Number : 21963
Submission : 2008-09-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33640
Submission : 2019-05-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12386
Submission : 1997-02-27
Status : Inactive
Type : II
A Calcifediol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcifediol, including repackagers and relabelers. The FDA regulates Calcifediol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcifediol 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 Calcifediol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calcifediol supplier is an individual or a company that provides Calcifediol active pharmaceutical ingredient (API) or Calcifediol finished formulations upon request. The Calcifediol suppliers may include Calcifediol API manufacturers, exporters, distributors and traders.
click here to find a list of Calcifediol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calcifediol DMF (Drug Master File) is a document detailing the whole manufacturing process of Calcifediol active pharmaceutical ingredient (API) in detail. Different forms of Calcifediol DMFs exist exist since differing nations have different regulations, such as Calcifediol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calcifediol DMF submitted to regulatory agencies in the US is known as a USDMF. Calcifediol USDMF includes data on Calcifediol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calcifediol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Calcifediol suppliers with USDMF on PharmaCompass.
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