01 1Industriale Chimica
01 1OXPRENOLOL HcL
01 1Italy
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4771
Submission : 1982-12-20
Status : Inactive
Type : II
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A Coretal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Coretal, including repackagers and relabelers. The FDA regulates Coretal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Coretal 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 Coretal supplier is an individual or a company that provides Coretal active pharmaceutical ingredient (API) or Coretal finished formulations upon request. The Coretal suppliers may include Coretal API manufacturers, exporters, distributors and traders.
click here to find a list of Coretal suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Coretal DMF (Drug Master File) is a document detailing the whole manufacturing process of Coretal active pharmaceutical ingredient (API) in detail. Different forms of Coretal DMFs exist exist since differing nations have different regulations, such as Coretal USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Coretal DMF submitted to regulatory agencies in the US is known as a USDMF. Coretal USDMF includes data on Coretal's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Coretal USDMF is kept confidential to protect the manufacturer’s intellectual property.
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