01 1Lonza Group
01 1PROPYLHEXEDRINE
01 1Switzerland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10389
Submission : 1993-07-29
Status : Inactive
Type : II
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A Obesin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Obesin, including repackagers and relabelers. The FDA regulates Obesin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Obesin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Obesin supplier is an individual or a company that provides Obesin active pharmaceutical ingredient (API) or Obesin finished formulations upon request. The Obesin suppliers may include Obesin API manufacturers, exporters, distributors and traders.
click here to find a list of Obesin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Obesin DMF (Drug Master File) is a document detailing the whole manufacturing process of Obesin active pharmaceutical ingredient (API) in detail. Different forms of Obesin DMFs exist exist since differing nations have different regulations, such as Obesin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Obesin DMF submitted to regulatory agencies in the US is known as a USDMF. Obesin USDMF includes data on Obesin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Obesin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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