01 1Bayer AG
01 1IPODATE SODIUM
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4365
Submission : 1981-09-22
Status : Inactive
Type : II
A Ipodate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ipodate, including repackagers and relabelers. The FDA regulates Ipodate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ipodate 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 Ipodate supplier is an individual or a company that provides Ipodate active pharmaceutical ingredient (API) or Ipodate finished formulations upon request. The Ipodate suppliers may include Ipodate API manufacturers, exporters, distributors and traders.
click here to find a list of Ipodate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ipodate DMF (Drug Master File) is a document detailing the whole manufacturing process of Ipodate active pharmaceutical ingredient (API) in detail. Different forms of Ipodate DMFs exist exist since differing nations have different regulations, such as Ipodate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ipodate DMF submitted to regulatory agencies in the US is known as a USDMF. Ipodate USDMF includes data on Ipodate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ipodate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ipodate suppliers with USDMF on PharmaCompass.
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