01 1Daiichi Sankyo
01 1SUN11031 (HUMAN GHRELIN) DRUG SUBSTANCE
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18461
Submission : 2005-06-30
Status : Active
Type : II
A Human Ghrelin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Human Ghrelin, including repackagers and relabelers. The FDA regulates Human Ghrelin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Human Ghrelin 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 Human Ghrelin supplier is an individual or a company that provides Human Ghrelin active pharmaceutical ingredient (API) or Human Ghrelin finished formulations upon request. The Human Ghrelin suppliers may include Human Ghrelin API manufacturers, exporters, distributors and traders.
click here to find a list of Human Ghrelin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Human Ghrelin DMF (Drug Master File) is a document detailing the whole manufacturing process of Human Ghrelin active pharmaceutical ingredient (API) in detail. Different forms of Human Ghrelin DMFs exist exist since differing nations have different regulations, such as Human Ghrelin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Human Ghrelin DMF submitted to regulatory agencies in the US is known as a USDMF. Human Ghrelin USDMF includes data on Human Ghrelin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Human Ghrelin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Human Ghrelin suppliers with USDMF on PharmaCompass.
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