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