01 1ALP Pharm
02 1HEC Pharm
03 1Indoco Remedies Limited
04 1Maithri Drugs
05 1Micro Labs Limited
06 1Blank
01 4BESIFLOXACIN HYDROCHLORIDE
02 1BESIFLOXACIN HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE
03 1SS734
01 2China
02 3India
03 1Blank
01 4Active
02 2Inactive
01 2Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32611
Submission : 2018-03-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32160
Submission : 2017-11-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-06
Pay. Date : 2017-02-16
DMF Number : 29303
Submission : 2015-07-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35809
Submission : 2021-03-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-12-22
Pay. Date : 2017-12-02
DMF Number : 31989
Submission : 2017-11-30
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16249
Submission : 2002-11-20
Status : Inactive
Type : II
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A Besifloxacin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Besifloxacin Hydrochloride, including repackagers and relabelers. The FDA regulates Besifloxacin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Besifloxacin 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 Besifloxacin Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Besifloxacin Hydrochloride supplier is an individual or a company that provides Besifloxacin Hydrochloride active pharmaceutical ingredient (API) or Besifloxacin Hydrochloride finished formulations upon request. The Besifloxacin Hydrochloride suppliers may include Besifloxacin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Besifloxacin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Besifloxacin Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Besifloxacin Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Besifloxacin Hydrochloride DMFs exist exist since differing nations have different regulations, such as Besifloxacin Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Besifloxacin Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Besifloxacin Hydrochloride USDMF includes data on Besifloxacin Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Besifloxacin Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Besifloxacin Hydrochloride suppliers with USDMF on PharmaCompass.
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