01 1Eli Lilly
01 1ALMITRINE BISMESYLATE TABLETS
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5742
Submission : 1984-08-17
Status : Inactive
Type : II
A Almitrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Almitrine, including repackagers and relabelers. The FDA regulates Almitrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Almitrine 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 Almitrine supplier is an individual or a company that provides Almitrine active pharmaceutical ingredient (API) or Almitrine finished formulations upon request. The Almitrine suppliers may include Almitrine API manufacturers, exporters, distributors and traders.
click here to find a list of Almitrine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Almitrine DMF (Drug Master File) is a document detailing the whole manufacturing process of Almitrine active pharmaceutical ingredient (API) in detail. Different forms of Almitrine DMFs exist exist since differing nations have different regulations, such as Almitrine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Almitrine DMF submitted to regulatory agencies in the US is known as a USDMF. Almitrine USDMF includes data on Almitrine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Almitrine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Almitrine suppliers with USDMF on PharmaCompass.
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