01 1Purisys LLC
02 2Filament Health
03 1Terran Biosciences
01 1PEX010 (PSILOCYBIN CAPSULE)
02 2PSILOCYBIN
03 1PYEX (PSILOCYBIN STANDARDIZED EXTRACT POWDER)
01 2Canada
02 2U.S.A
01 4Active
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37635
Submission : 2023-01-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36004
Submission : 2021-07-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35999
Submission : 2021-06-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38418
Submission : 2023-05-18
Status : Active
Type : II
A Psilocybine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Psilocybine, including repackagers and relabelers. The FDA regulates Psilocybine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Psilocybine 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 Psilocybine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Psilocybine supplier is an individual or a company that provides Psilocybine active pharmaceutical ingredient (API) or Psilocybine finished formulations upon request. The Psilocybine suppliers may include Psilocybine API manufacturers, exporters, distributors and traders.
click here to find a list of Psilocybine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Psilocybine DMF (Drug Master File) is a document detailing the whole manufacturing process of Psilocybine active pharmaceutical ingredient (API) in detail. Different forms of Psilocybine DMFs exist exist since differing nations have different regulations, such as Psilocybine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Psilocybine DMF submitted to regulatory agencies in the US is known as a USDMF. Psilocybine USDMF includes data on Psilocybine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Psilocybine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Psilocybine suppliers with USDMF on PharmaCompass.
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