01 1Cambrex Corporation
01 1MAGNESIUM OXYBATE
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-06-23
Pay. Date : 2022-05-17
DMF Number : 35871
Submission : 2022-05-26
Status : Active
Type : II
A Magnesium Oxybate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Magnesium Oxybate, including repackagers and relabelers. The FDA regulates Magnesium Oxybate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Magnesium Oxybate 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 Magnesium Oxybate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Magnesium Oxybate supplier is an individual or a company that provides Magnesium Oxybate active pharmaceutical ingredient (API) or Magnesium Oxybate finished formulations upon request. The Magnesium Oxybate suppliers may include Magnesium Oxybate API manufacturers, exporters, distributors and traders.
click here to find a list of Magnesium Oxybate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Magnesium Oxybate DMF (Drug Master File) is a document detailing the whole manufacturing process of Magnesium Oxybate active pharmaceutical ingredient (API) in detail. Different forms of Magnesium Oxybate DMFs exist exist since differing nations have different regulations, such as Magnesium Oxybate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Magnesium Oxybate DMF submitted to regulatory agencies in the US is known as a USDMF. Magnesium Oxybate USDMF includes data on Magnesium Oxybate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Magnesium Oxybate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Magnesium Oxybate suppliers with USDMF on PharmaCompass.
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