01 1Sunpure Extracts
01 1ASHWAGANDHA EXTRACT POWDER
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34060
Submission : 2019-08-10
Status : Active
Type : II
A Ashwagandha manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ashwagandha, including repackagers and relabelers. The FDA regulates Ashwagandha manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ashwagandha 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 Ashwagandha manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ashwagandha supplier is an individual or a company that provides Ashwagandha active pharmaceutical ingredient (API) or Ashwagandha finished formulations upon request. The Ashwagandha suppliers may include Ashwagandha API manufacturers, exporters, distributors and traders.
click here to find a list of Ashwagandha suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ashwagandha DMF (Drug Master File) is a document detailing the whole manufacturing process of Ashwagandha active pharmaceutical ingredient (API) in detail. Different forms of Ashwagandha DMFs exist exist since differing nations have different regulations, such as Ashwagandha USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ashwagandha DMF submitted to regulatory agencies in the US is known as a USDMF. Ashwagandha USDMF includes data on Ashwagandha's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ashwagandha USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ashwagandha suppliers with USDMF on PharmaCompass.
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