01 1Purisys LLC
02 1FineTech Pharmaceutical Ltd.
01 1NABILONE
02 1NABILONE DRUG SUBSTANCE
01 1Israel
02 1U.S.A
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35408
Submission : 2020-12-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31946
Submission : 2017-08-14
Status : Active
Type : II
A Cesamet manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cesamet, including repackagers and relabelers. The FDA regulates Cesamet manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cesamet 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 Cesamet manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cesamet supplier is an individual or a company that provides Cesamet active pharmaceutical ingredient (API) or Cesamet finished formulations upon request. The Cesamet suppliers may include Cesamet API manufacturers, exporters, distributors and traders.
click here to find a list of Cesamet suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cesamet DMF (Drug Master File) is a document detailing the whole manufacturing process of Cesamet active pharmaceutical ingredient (API) in detail. Different forms of Cesamet DMFs exist exist since differing nations have different regulations, such as Cesamet USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cesamet DMF submitted to regulatory agencies in the US is known as a USDMF. Cesamet USDMF includes data on Cesamet's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cesamet USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cesamet suppliers with USDMF on PharmaCompass.
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