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