01 1Shandong Freda Biotechnology
01 1NATAMYCIN
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42063
Submission : 2025-06-09
Status : Active
Type : II
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A E235 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of E235, including repackagers and relabelers. The FDA regulates E235 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. E235 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 E235 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A E235 supplier is an individual or a company that provides E235 active pharmaceutical ingredient (API) or E235 finished formulations upon request. The E235 suppliers may include E235 API manufacturers, exporters, distributors and traders.
click here to find a list of E235 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A E235 DMF (Drug Master File) is a document detailing the whole manufacturing process of E235 active pharmaceutical ingredient (API) in detail. Different forms of E235 DMFs exist exist since differing nations have different regulations, such as E235 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A E235 DMF submitted to regulatory agencies in the US is known as a USDMF. E235 USDMF includes data on E235's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The E235 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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