01 1SIGMA TAU
01 1COUMARIN
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5652
Submission : 1985-01-04
Status : Inactive
Type : II
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A Tonka bean camphor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tonka bean camphor, including repackagers and relabelers. The FDA regulates Tonka bean camphor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tonka bean camphor 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 Tonka bean camphor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Tonka bean camphor supplier is an individual or a company that provides Tonka bean camphor active pharmaceutical ingredient (API) or Tonka bean camphor finished formulations upon request. The Tonka bean camphor suppliers may include Tonka bean camphor API manufacturers, exporters, distributors and traders.
click here to find a list of Tonka bean camphor suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Tonka bean camphor DMF (Drug Master File) is a document detailing the whole manufacturing process of Tonka bean camphor active pharmaceutical ingredient (API) in detail. Different forms of Tonka bean camphor DMFs exist exist since differing nations have different regulations, such as Tonka bean camphor USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tonka bean camphor DMF submitted to regulatory agencies in the US is known as a USDMF. Tonka bean camphor USDMF includes data on Tonka bean camphor's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tonka bean camphor USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tonka bean camphor suppliers with USDMF on PharmaCompass.
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