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