01 1Merck Serono
01 1BULK GRF (1-29) NH2 (SERMORELIN ACETATE DRUG SUBSTANCE)
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10293
Submission : 1993-06-11
Status : Inactive
Type : II
A Sermorelin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sermorelin, including repackagers and relabelers. The FDA regulates Sermorelin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sermorelin 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 Sermorelin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sermorelin supplier is an individual or a company that provides Sermorelin active pharmaceutical ingredient (API) or Sermorelin finished formulations upon request. The Sermorelin suppliers may include Sermorelin API manufacturers, exporters, distributors and traders.
click here to find a list of Sermorelin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sermorelin DMF (Drug Master File) is a document detailing the whole manufacturing process of Sermorelin active pharmaceutical ingredient (API) in detail. Different forms of Sermorelin DMFs exist exist since differing nations have different regulations, such as Sermorelin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sermorelin DMF submitted to regulatory agencies in the US is known as a USDMF. Sermorelin USDMF includes data on Sermorelin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sermorelin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sermorelin suppliers with USDMF on PharmaCompass.
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