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