Suanfarma, at the Core of a Better Life.
01 1Suanfarma
02 2Curia
03 3Hovione
04 1IDT Australia Limited
05 2Kyowa Hakko Bio
06 1Nippon Kayaku
07 2Pfizer Inc
08 1Zhejiang Hisun Pharmaceutical
09 2Zhejiang Medicine Co Ltd
Suanfarma, at the Core of a Better Life.
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-02
Pay. Date : 2013-06-20
DMF Number : 13758
Submission : 1998-09-01
Status :
Type : II
100
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A Minomax manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Minomax, including repackagers and relabelers. The FDA regulates Minomax manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Minomax 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 Minomax supplier is an individual or a company that provides Minomax active pharmaceutical ingredient (API) or Minomax finished formulations upon request. The Minomax suppliers may include Minomax API manufacturers, exporters, distributors and traders.
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A Minomax DMF (Drug Master File) is a document detailing the whole manufacturing process of Minomax active pharmaceutical ingredient (API) in detail. Different forms of Minomax DMFs exist exist since differing nations have different regulations, such as Minomax USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Minomax DMF submitted to regulatory agencies in the US is known as a USDMF. Minomax USDMF includes data on Minomax's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Minomax USDMF is kept confidential to protect the manufacturer’s intellectual property.
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