01 1Procos
01 1EMBUTRAMIDE
01 1Italy
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11004
Submission : 1994-07-21
Status : Active
Type : II
A Embutramide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Embutramide, including repackagers and relabelers. The FDA regulates Embutramide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Embutramide 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 Embutramide supplier is an individual or a company that provides Embutramide active pharmaceutical ingredient (API) or Embutramide finished formulations upon request. The Embutramide suppliers may include Embutramide API manufacturers, exporters, distributors and traders.
click here to find a list of Embutramide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Embutramide DMF (Drug Master File) is a document detailing the whole manufacturing process of Embutramide active pharmaceutical ingredient (API) in detail. Different forms of Embutramide DMFs exist exist since differing nations have different regulations, such as Embutramide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Embutramide DMF submitted to regulatory agencies in the US is known as a USDMF. Embutramide USDMF includes data on Embutramide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Embutramide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Embutramide suppliers with USDMF on PharmaCompass.
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