01 1Cambrex Corporation
01 1POTASSIUM OXYBATE
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-07-25
Pay. Date : 2022-05-17
DMF Number : 35872
Submission : 2022-04-26
Status : Active
Type : II
58
PharmaCompass offers a list of Potassium Oxybate 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 Potassium Oxybate manufacturer or Potassium Oxybate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Potassium Oxybate manufacturer or Potassium Oxybate supplier.
A Potassium Oxybate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium Oxybate, including repackagers and relabelers. The FDA regulates Potassium Oxybate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium 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.
A Potassium Oxybate supplier is an individual or a company that provides Potassium Oxybate active pharmaceutical ingredient (API) or Potassium Oxybate finished formulations upon request. The Potassium Oxybate suppliers may include Potassium Oxybate API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium Oxybate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Potassium Oxybate DMF (Drug Master File) is a document detailing the whole manufacturing process of Potassium Oxybate active pharmaceutical ingredient (API) in detail. Different forms of Potassium Oxybate DMFs exist exist since differing nations have different regulations, such as Potassium Oxybate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Potassium Oxybate DMF submitted to regulatory agencies in the US is known as a USDMF. Potassium Oxybate USDMF includes data on Potassium Oxybate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Potassium Oxybate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Potassium Oxybate suppliers with USDMF on PharmaCompass.
We have 1 companies offering Potassium Oxybate
Get in contact with the supplier of your choice:
