01 1Endura
01 1PIPERONYL BUTOXIDE
01 1Italy
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13137
Submission : 1998-08-07
Status : Inactive
Type : II
17
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A Pybuthrin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pybuthrin, including repackagers and relabelers. The FDA regulates Pybuthrin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pybuthrin 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 Pybuthrin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Pybuthrin supplier is an individual or a company that provides Pybuthrin active pharmaceutical ingredient (API) or Pybuthrin finished formulations upon request. The Pybuthrin suppliers may include Pybuthrin API manufacturers, exporters, distributors and traders.
click here to find a list of Pybuthrin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Pybuthrin DMF (Drug Master File) is a document detailing the whole manufacturing process of Pybuthrin active pharmaceutical ingredient (API) in detail. Different forms of Pybuthrin DMFs exist exist since differing nations have different regulations, such as Pybuthrin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pybuthrin DMF submitted to regulatory agencies in the US is known as a USDMF. Pybuthrin USDMF includes data on Pybuthrin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pybuthrin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pybuthrin suppliers with USDMF on PharmaCompass.
