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