01 1ORGANICA Feinchemie GmbH Wolfen
01 1HYPERPOLARIZED HELIUM-3 GAS (HP-3HE)
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13924
Submission : 1998-12-30
Status : Inactive
Type : II
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PharmaCompass offers a list of Helium-3 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 Helium-3 manufacturer or Helium-3 supplier for your needs.
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A Helium-3 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Helium-3, including repackagers and relabelers. The FDA regulates Helium-3 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Helium-3 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 Helium-3 supplier is an individual or a company that provides Helium-3 active pharmaceutical ingredient (API) or Helium-3 finished formulations upon request. The Helium-3 suppliers may include Helium-3 API manufacturers, exporters, distributors and traders.
click here to find a list of Helium-3 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Helium-3 DMF (Drug Master File) is a document detailing the whole manufacturing process of Helium-3 active pharmaceutical ingredient (API) in detail. Different forms of Helium-3 DMFs exist exist since differing nations have different regulations, such as Helium-3 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Helium-3 DMF submitted to regulatory agencies in the US is known as a USDMF. Helium-3 USDMF includes data on Helium-3's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Helium-3 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Helium-3 suppliers with USDMF on PharmaCompass.
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