01 1Fujifilm Diosynth Biotechnologies
01 1NORETHYNODREL
01 1United Kingdom
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4709
Submission : 1982-11-12
Status : Inactive
Type : II
A Norethynodrel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Norethynodrel, including repackagers and relabelers. The FDA regulates Norethynodrel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Norethynodrel 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 Norethynodrel supplier is an individual or a company that provides Norethynodrel active pharmaceutical ingredient (API) or Norethynodrel finished formulations upon request. The Norethynodrel suppliers may include Norethynodrel API manufacturers, exporters, distributors and traders.
click here to find a list of Norethynodrel suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Norethynodrel DMF (Drug Master File) is a document detailing the whole manufacturing process of Norethynodrel active pharmaceutical ingredient (API) in detail. Different forms of Norethynodrel DMFs exist exist since differing nations have different regulations, such as Norethynodrel USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Norethynodrel DMF submitted to regulatory agencies in the US is known as a USDMF. Norethynodrel USDMF includes data on Norethynodrel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Norethynodrel USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Norethynodrel suppliers with USDMF on PharmaCompass.
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