01 1Sonac
01 1HEMIN
01 1Netherlands
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11037
Submission : 1994-07-29
Status : Inactive
Type : II
98
PharmaCompass offers a list of Hemin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Hemin manufacturer or Hemin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hemin manufacturer or Hemin supplier.
A Hemin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hemin, including repackagers and relabelers. The FDA regulates Hemin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hemin 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 Hemin supplier is an individual or a company that provides Hemin active pharmaceutical ingredient (API) or Hemin finished formulations upon request. The Hemin suppliers may include Hemin API manufacturers, exporters, distributors and traders.
click here to find a list of Hemin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Hemin DMF (Drug Master File) is a document detailing the whole manufacturing process of Hemin active pharmaceutical ingredient (API) in detail. Different forms of Hemin DMFs exist exist since differing nations have different regulations, such as Hemin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hemin DMF submitted to regulatory agencies in the US is known as a USDMF. Hemin USDMF includes data on Hemin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hemin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hemin suppliers with USDMF on PharmaCompass.
