01 1Newgen Biotech USA
01 1BETA 1, 3/1, 6 GLUCAN
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31147
Submission : 2016-11-10
Status : Active
Type : II
A Beta Glucan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Beta Glucan, including repackagers and relabelers. The FDA regulates Beta Glucan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Beta Glucan 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 Beta Glucan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Beta Glucan supplier is an individual or a company that provides Beta Glucan active pharmaceutical ingredient (API) or Beta Glucan finished formulations upon request. The Beta Glucan suppliers may include Beta Glucan API manufacturers, exporters, distributors and traders.
click here to find a list of Beta Glucan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Beta Glucan DMF (Drug Master File) is a document detailing the whole manufacturing process of Beta Glucan active pharmaceutical ingredient (API) in detail. Different forms of Beta Glucan DMFs exist exist since differing nations have different regulations, such as Beta Glucan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Beta Glucan DMF submitted to regulatory agencies in the US is known as a USDMF. Beta Glucan USDMF includes data on Beta Glucan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Beta Glucan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Beta Glucan suppliers with USDMF on PharmaCompass.
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