01 1Kaken Pharmaceuticals
01 1KP-102
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10256
Submission : 1993-05-24
Status : Inactive
Type : II
A Pralmorelin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pralmorelin, including repackagers and relabelers. The FDA regulates Pralmorelin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pralmorelin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Pralmorelin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pralmorelin supplier is an individual or a company that provides Pralmorelin active pharmaceutical ingredient (API) or Pralmorelin finished formulations upon request. The Pralmorelin suppliers may include Pralmorelin API manufacturers, exporters, distributors and traders.
click here to find a list of Pralmorelin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pralmorelin DMF (Drug Master File) is a document detailing the whole manufacturing process of Pralmorelin active pharmaceutical ingredient (API) in detail. Different forms of Pralmorelin DMFs exist exist since differing nations have different regulations, such as Pralmorelin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pralmorelin DMF submitted to regulatory agencies in the US is known as a USDMF. Pralmorelin USDMF includes data on Pralmorelin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pralmorelin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pralmorelin suppliers with USDMF on PharmaCompass.
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