01 1CordenPharma
01 1LARAZOTIDE
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18561
Submission : 2005-08-05
Status : Inactive
Type : II
A Larazotide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Larazotide, including repackagers and relabelers. The FDA regulates Larazotide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Larazotide 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 Larazotide supplier is an individual or a company that provides Larazotide active pharmaceutical ingredient (API) or Larazotide finished formulations upon request. The Larazotide suppliers may include Larazotide API manufacturers, exporters, distributors and traders.
click here to find a list of Larazotide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Larazotide DMF (Drug Master File) is a document detailing the whole manufacturing process of Larazotide active pharmaceutical ingredient (API) in detail. Different forms of Larazotide DMFs exist exist since differing nations have different regulations, such as Larazotide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Larazotide DMF submitted to regulatory agencies in the US is known as a USDMF. Larazotide USDMF includes data on Larazotide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Larazotide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Larazotide suppliers with USDMF on PharmaCompass.
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