01 1Sunpure Extracts
01 1GINGER EXTRACT POWDER (GINGEROLS 5 AND 20)
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34059
Submission : 2019-08-10
Status : Active
Type : II
A Gingerol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gingerol, including repackagers and relabelers. The FDA regulates Gingerol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gingerol 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 Gingerol supplier is an individual or a company that provides Gingerol active pharmaceutical ingredient (API) or Gingerol finished formulations upon request. The Gingerol suppliers may include Gingerol API manufacturers, exporters, distributors and traders.
click here to find a list of Gingerol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gingerol DMF (Drug Master File) is a document detailing the whole manufacturing process of Gingerol active pharmaceutical ingredient (API) in detail. Different forms of Gingerol DMFs exist exist since differing nations have different regulations, such as Gingerol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gingerol DMF submitted to regulatory agencies in the US is known as a USDMF. Gingerol USDMF includes data on Gingerol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gingerol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gingerol suppliers with USDMF on PharmaCompass.
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