01 1Daiichi Sankyo
01 1DR-3355 BULK SUBSTANCE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8565
Submission : 1990-05-14
Status : Inactive
Type : II
A Levofloxacin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levofloxacin Hydrochloride, including repackagers and relabelers. The FDA regulates Levofloxacin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levofloxacin Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Levofloxacin Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levofloxacin Hydrochloride supplier is an individual or a company that provides Levofloxacin Hydrochloride active pharmaceutical ingredient (API) or Levofloxacin Hydrochloride finished formulations upon request. The Levofloxacin Hydrochloride suppliers may include Levofloxacin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Levofloxacin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levofloxacin Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Levofloxacin Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Levofloxacin Hydrochloride DMFs exist exist since differing nations have different regulations, such as Levofloxacin Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levofloxacin Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Levofloxacin Hydrochloride USDMF includes data on Levofloxacin Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levofloxacin Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levofloxacin Hydrochloride suppliers with USDMF on PharmaCompass.
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