01 2Bayer AG
02 1Olon S.p.A
03 2Blank
01 1BAYER 2353 (YOMESAN)
02 2NICLOSAMIDE
03 1NICLOSAMIDE 500MG TABLET
04 1NICLOSAMIDE ANHYDROUS DRUG SUBSTANCE
01 2Germany
02 1Italy
03 2Blank
01 1Active
02 4Inactive
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25273
Submission : 2011-10-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25274
Submission : 2011-10-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34597
Submission : 2020-02-13
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4146
Submission : 1981-01-31
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 557
Submission : 1963-05-20
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Niclosamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Niclosamide, including repackagers and relabelers. The FDA regulates Niclosamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Niclosamide 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 Niclosamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Niclosamide supplier is an individual or a company that provides Niclosamide active pharmaceutical ingredient (API) or Niclosamide finished formulations upon request. The Niclosamide suppliers may include Niclosamide API manufacturers, exporters, distributors and traders.
click here to find a list of Niclosamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Niclosamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Niclosamide active pharmaceutical ingredient (API) in detail. Different forms of Niclosamide DMFs exist exist since differing nations have different regulations, such as Niclosamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Niclosamide DMF submitted to regulatory agencies in the US is known as a USDMF. Niclosamide USDMF includes data on Niclosamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Niclosamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Niclosamide suppliers with USDMF on PharmaCompass.
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