01 1Cambrex Corporation
01 1CALCIUM OXYBATE
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-06-30
Pay. Date : 2022-05-17
DMF Number : 35873
Submission : 2022-06-10
Status : Active
Type : II
A Calcium Oxybate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcium Oxybate, including repackagers and relabelers. The FDA regulates Calcium Oxybate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcium 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 Calcium Oxybate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calcium Oxybate supplier is an individual or a company that provides Calcium Oxybate active pharmaceutical ingredient (API) or Calcium Oxybate finished formulations upon request. The Calcium Oxybate suppliers may include Calcium Oxybate API manufacturers, exporters, distributors and traders.
click here to find a list of Calcium Oxybate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calcium Oxybate DMF (Drug Master File) is a document detailing the whole manufacturing process of Calcium Oxybate active pharmaceutical ingredient (API) in detail. Different forms of Calcium Oxybate DMFs exist exist since differing nations have different regulations, such as Calcium Oxybate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calcium Oxybate DMF submitted to regulatory agencies in the US is known as a USDMF. Calcium Oxybate USDMF includes data on Calcium Oxybate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calcium Oxybate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Calcium Oxybate suppliers with USDMF on PharmaCompass.
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