01 1Wyeth Pharmaceuticals Inc
01 1DEXPROPRANOLOL INJ
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2265
Submission : 1974-04-25
Status : Inactive
Type : II
A Dexpropranolol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexpropranolol, including repackagers and relabelers. The FDA regulates Dexpropranolol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexpropranolol 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 Dexpropranolol supplier is an individual or a company that provides Dexpropranolol active pharmaceutical ingredient (API) or Dexpropranolol finished formulations upon request. The Dexpropranolol suppliers may include Dexpropranolol API manufacturers, exporters, distributors and traders.
click here to find a list of Dexpropranolol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dexpropranolol DMF (Drug Master File) is a document detailing the whole manufacturing process of Dexpropranolol active pharmaceutical ingredient (API) in detail. Different forms of Dexpropranolol DMFs exist exist since differing nations have different regulations, such as Dexpropranolol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dexpropranolol DMF submitted to regulatory agencies in the US is known as a USDMF. Dexpropranolol USDMF includes data on Dexpropranolol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dexpropranolol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dexpropranolol suppliers with USDMF on PharmaCompass.
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