Experts in producing high-quality APIs from natural sources, specializing in advanced extraction and isolation techniques.
01 1Phytex Australia
01 1CASTANOSPERMINE
01 1Australia
01 1Active
01 1Blank
Experts in producing high-quality APIs from natural sources, specializing in advanced extraction and isolation techniques.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10880
Submission : 1994-04-25
Status : Active
Type : II
A Castanospermine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Castanospermine, including repackagers and relabelers. The FDA regulates Castanospermine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Castanospermine 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 Castanospermine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Castanospermine supplier is an individual or a company that provides Castanospermine active pharmaceutical ingredient (API) or Castanospermine finished formulations upon request. The Castanospermine suppliers may include Castanospermine API manufacturers, exporters, distributors and traders.
click here to find a list of Castanospermine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Castanospermine DMF (Drug Master File) is a document detailing the whole manufacturing process of Castanospermine active pharmaceutical ingredient (API) in detail. Different forms of Castanospermine DMFs exist exist since differing nations have different regulations, such as Castanospermine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Castanospermine DMF submitted to regulatory agencies in the US is known as a USDMF. Castanospermine USDMF includes data on Castanospermine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Castanospermine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Castanospermine suppliers with USDMF on PharmaCompass.
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