01 1Sandoz B2B
01 1BOPINDOLOL
01 1Switzerland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5452
Submission : 1984-07-02
Status : Inactive
Type : II
A Bopindolol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bopindolol, including repackagers and relabelers. The FDA regulates Bopindolol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bopindolol 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 Bopindolol supplier is an individual or a company that provides Bopindolol active pharmaceutical ingredient (API) or Bopindolol finished formulations upon request. The Bopindolol suppliers may include Bopindolol API manufacturers, exporters, distributors and traders.
click here to find a list of Bopindolol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bopindolol DMF (Drug Master File) is a document detailing the whole manufacturing process of Bopindolol active pharmaceutical ingredient (API) in detail. Different forms of Bopindolol DMFs exist exist since differing nations have different regulations, such as Bopindolol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bopindolol DMF submitted to regulatory agencies in the US is known as a USDMF. Bopindolol USDMF includes data on Bopindolol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bopindolol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bopindolol suppliers with USDMF on PharmaCompass.
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