Suanfarma, at the Core of a Better Life.
01 1Suanfarma
02 2Abbott Laboratories
03 1Archimica
04 1Dupont
05 5Pfizer Inc
06 1The Dow Chemical Company
07 6Blank
Suanfarma, at the Core of a Better Life.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13360
Submission : 1998-09-01
Status :
Type : II
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A Limecycline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Limecycline, including repackagers and relabelers. The FDA regulates Limecycline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Limecycline 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 Limecycline DMF (Drug Master File) is a document detailing the whole manufacturing process of Limecycline active pharmaceutical ingredient (API) in detail. Different forms of Limecycline DMFs exist exist since differing nations have different regulations, such as Limecycline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Limecycline DMF submitted to regulatory agencies in the US is known as a USDMF. Limecycline USDMF includes data on Limecycline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Limecycline USDMF is kept confidential to protect the manufacturer’s intellectual property.
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