01 1Novo Nordisk
01 1NORDITROPIN (BIOSYNTHETIC HUMAN GROWTH HORMONE, SOMATROPIN)
01 1Denmark
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6970
Submission : 1987-04-14
Status : Inactive
Type : II
A Nortropin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nortropin, including repackagers and relabelers. The FDA regulates Nortropin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nortropin 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 Nortropin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nortropin supplier is an individual or a company that provides Nortropin active pharmaceutical ingredient (API) or Nortropin finished formulations upon request. The Nortropin suppliers may include Nortropin API manufacturers, exporters, distributors and traders.
click here to find a list of Nortropin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nortropin DMF (Drug Master File) is a document detailing the whole manufacturing process of Nortropin active pharmaceutical ingredient (API) in detail. Different forms of Nortropin DMFs exist exist since differing nations have different regulations, such as Nortropin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nortropin DMF submitted to regulatory agencies in the US is known as a USDMF. Nortropin USDMF includes data on Nortropin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nortropin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nortropin suppliers with USDMF on PharmaCompass.
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