01 1Roche Diagnostics GmbH
01 1GUAIACOL-O-ETHYLTOSYLATE
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9532
Submission : 1992-02-06
Status : Inactive
Type : II
72
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A 137309-88-7 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 137309-88-7, including repackagers and relabelers. The FDA regulates 137309-88-7 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 137309-88-7 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 137309-88-7 supplier is an individual or a company that provides 137309-88-7 active pharmaceutical ingredient (API) or 137309-88-7 finished formulations upon request. The 137309-88-7 suppliers may include 137309-88-7 API manufacturers, exporters, distributors and traders.
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A 137309-88-7 DMF (Drug Master File) is a document detailing the whole manufacturing process of 137309-88-7 active pharmaceutical ingredient (API) in detail. Different forms of 137309-88-7 DMFs exist exist since differing nations have different regulations, such as 137309-88-7 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 137309-88-7 DMF submitted to regulatory agencies in the US is known as a USDMF. 137309-88-7 USDMF includes data on 137309-88-7's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 137309-88-7 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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