01 1New Zealand Pharmaceuticals Ltd
01 1N-ACETYL-D-MANNOSAMINE MONOHYDRATE (MANNAC)
01 1New Zealand
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33683
Submission : 2019-05-01
Status : Active
Type : II
A N-Acetyl-D-Mannosamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N-Acetyl-D-Mannosamine, including repackagers and relabelers. The FDA regulates N-Acetyl-D-Mannosamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N-Acetyl-D-Mannosamine 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 N-Acetyl-D-Mannosamine supplier is an individual or a company that provides N-Acetyl-D-Mannosamine active pharmaceutical ingredient (API) or N-Acetyl-D-Mannosamine finished formulations upon request. The N-Acetyl-D-Mannosamine suppliers may include N-Acetyl-D-Mannosamine API manufacturers, exporters, distributors and traders.
click here to find a list of N-Acetyl-D-Mannosamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A N-Acetyl-D-Mannosamine DMF (Drug Master File) is a document detailing the whole manufacturing process of N-Acetyl-D-Mannosamine active pharmaceutical ingredient (API) in detail. Different forms of N-Acetyl-D-Mannosamine DMFs exist exist since differing nations have different regulations, such as N-Acetyl-D-Mannosamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A N-Acetyl-D-Mannosamine DMF submitted to regulatory agencies in the US is known as a USDMF. N-Acetyl-D-Mannosamine USDMF includes data on N-Acetyl-D-Mannosamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The N-Acetyl-D-Mannosamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of N-Acetyl-D-Mannosamine suppliers with USDMF on PharmaCompass.
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