01 1Sunpure Extracts
01 1ANDROGRAPHIS PANICULATA DRY EXTRACT
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36461
Submission : 2021-11-18
Status : Active
Type : II
A Andrographolide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Andrographolide, including repackagers and relabelers. The FDA regulates Andrographolide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Andrographolide 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 Andrographolide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Andrographolide supplier is an individual or a company that provides Andrographolide active pharmaceutical ingredient (API) or Andrographolide finished formulations upon request. The Andrographolide suppliers may include Andrographolide API manufacturers, exporters, distributors and traders.
click here to find a list of Andrographolide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Andrographolide DMF (Drug Master File) is a document detailing the whole manufacturing process of Andrographolide active pharmaceutical ingredient (API) in detail. Different forms of Andrographolide DMFs exist exist since differing nations have different regulations, such as Andrographolide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Andrographolide DMF submitted to regulatory agencies in the US is known as a USDMF. Andrographolide USDMF includes data on Andrographolide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Andrographolide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Andrographolide suppliers with USDMF on PharmaCompass.
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