01 1Kappa Bioscience
01 1K2VITAL® MK-7
01 1Norway
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30205
Submission : 2016-02-25
Status : Inactive
Type : II
A Vitamin K2 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vitamin K2, including repackagers and relabelers. The FDA regulates Vitamin K2 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vitamin K2 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 Vitamin K2 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vitamin K2 supplier is an individual or a company that provides Vitamin K2 active pharmaceutical ingredient (API) or Vitamin K2 finished formulations upon request. The Vitamin K2 suppliers may include Vitamin K2 API manufacturers, exporters, distributors and traders.
click here to find a list of Vitamin K2 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vitamin K2 DMF (Drug Master File) is a document detailing the whole manufacturing process of Vitamin K2 active pharmaceutical ingredient (API) in detail. Different forms of Vitamin K2 DMFs exist exist since differing nations have different regulations, such as Vitamin K2 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vitamin K2 DMF submitted to regulatory agencies in the US is known as a USDMF. Vitamin K2 USDMF includes data on Vitamin K2's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vitamin K2 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vitamin K2 suppliers with USDMF on PharmaCompass.
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