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