01 1Chemspec-API
01 1MENADIOL SODIUM DIPHOSPHATE
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25454
Submission : 2011-11-15
Status : Active
Type : II
A Menadiol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Menadiol, including repackagers and relabelers. The FDA regulates Menadiol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Menadiol 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 Menadiol supplier is an individual or a company that provides Menadiol active pharmaceutical ingredient (API) or Menadiol finished formulations upon request. The Menadiol suppliers may include Menadiol API manufacturers, exporters, distributors and traders.
click here to find a list of Menadiol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Menadiol DMF (Drug Master File) is a document detailing the whole manufacturing process of Menadiol active pharmaceutical ingredient (API) in detail. Different forms of Menadiol DMFs exist exist since differing nations have different regulations, such as Menadiol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Menadiol DMF submitted to regulatory agencies in the US is known as a USDMF. Menadiol USDMF includes data on Menadiol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Menadiol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Menadiol suppliers with USDMF on PharmaCompass.
LOOKING FOR A SUPPLIER?
