01 3Johnson & Johnson Innovative Medicine
01 1LEVAMISOLE DRUG SUBSTANCE
02 1LEVAMISOLE HCL-R 12564
03 1LEVAMISOLE HYDROCHLORIDE CRUDE
01 3U.S.A
01 3Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6079
Submission : 1985-10-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11015
Submission : 1994-08-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10995
Submission : 1994-07-21
Status : Inactive
Type : II
A Levamisole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levamisole, including repackagers and relabelers. The FDA regulates Levamisole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levamisole 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 Levamisole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levamisole supplier is an individual or a company that provides Levamisole active pharmaceutical ingredient (API) or Levamisole finished formulations upon request. The Levamisole suppliers may include Levamisole API manufacturers, exporters, distributors and traders.
click here to find a list of Levamisole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levamisole DMF (Drug Master File) is a document detailing the whole manufacturing process of Levamisole active pharmaceutical ingredient (API) in detail. Different forms of Levamisole DMFs exist exist since differing nations have different regulations, such as Levamisole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levamisole DMF submitted to regulatory agencies in the US is known as a USDMF. Levamisole USDMF includes data on Levamisole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levamisole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levamisole suppliers with USDMF on PharmaCompass.
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