Suanfarma, at the Core of a Better Life.
01 1Suanfarma
02 1Bristol Myers Squibb
03 2Fermic
04 1Fujian Fukang Pharmaceutical
05 1Gyma Laboratories of America
06 1Ningxia Kingvit Pharmaceutical Co Ltd
07 1Ningxia Qiyuan Pharmaceutical
08 8Pfizer Inc
09 1Roche Diagnostics GmbH
10 1Sichuan Sunnyhope Pharmaceutical
11 1XIAN LIJUN PHARMACEUTICAL
12 6Blank
Suanfarma, at the Core of a Better Life.
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-24
Pay. Date : 2013-07-31
DMF Number : 13339
Submission : 1998-09-01
Status :
Type : II
75
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A Supramycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Supramycin, including repackagers and relabelers. The FDA regulates Supramycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Supramycin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Supramycin DMF (Drug Master File) is a document detailing the whole manufacturing process of Supramycin active pharmaceutical ingredient (API) in detail. Different forms of Supramycin DMFs exist exist since differing nations have different regulations, such as Supramycin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Supramycin DMF submitted to regulatory agencies in the US is known as a USDMF. Supramycin USDMF includes data on Supramycin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Supramycin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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