01 1Sigma-Aldrich Corporation
01 1PHLORIDZIN FROM APPLE SIGMA PRODUCT NO. P0289
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12304
Submission : 1997-01-03
Status : Inactive
Type : II
A Phlorhizin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phlorhizin, including repackagers and relabelers. The FDA regulates Phlorhizin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phlorhizin 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 Phlorhizin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phlorhizin supplier is an individual or a company that provides Phlorhizin active pharmaceutical ingredient (API) or Phlorhizin finished formulations upon request. The Phlorhizin suppliers may include Phlorhizin API manufacturers, exporters, distributors and traders.
click here to find a list of Phlorhizin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Phlorhizin DMF (Drug Master File) is a document detailing the whole manufacturing process of Phlorhizin active pharmaceutical ingredient (API) in detail. Different forms of Phlorhizin DMFs exist exist since differing nations have different regulations, such as Phlorhizin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Phlorhizin DMF submitted to regulatory agencies in the US is known as a USDMF. Phlorhizin USDMF includes data on Phlorhizin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phlorhizin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Phlorhizin suppliers with USDMF on PharmaCompass.
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