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