01 1Johnson & Johnson Innovative Medicine
01 1LUBELUZOLE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12542
Submission : 1997-06-05
Status : Inactive
Type : II
97
PharmaCompass offers a list of Lubeluzole API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Lubeluzole manufacturer or Lubeluzole supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lubeluzole manufacturer or Lubeluzole supplier.
PharmaCompass also assists you with knowing the Lubeluzole API Price utilized in the formulation of products. Lubeluzole API Price is not always fixed or binding as the Lubeluzole Price is obtained through a variety of data sources. The Lubeluzole Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lubeluzole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lubeluzole, including repackagers and relabelers. The FDA regulates Lubeluzole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lubeluzole API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Lubeluzole supplier is an individual or a company that provides Lubeluzole active pharmaceutical ingredient (API) or Lubeluzole finished formulations upon request. The Lubeluzole suppliers may include Lubeluzole API manufacturers, exporters, distributors and traders.
click here to find a list of Lubeluzole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lubeluzole DMF (Drug Master File) is a document detailing the whole manufacturing process of Lubeluzole active pharmaceutical ingredient (API) in detail. Different forms of Lubeluzole DMFs exist exist since differing nations have different regulations, such as Lubeluzole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lubeluzole DMF submitted to regulatory agencies in the US is known as a USDMF. Lubeluzole USDMF includes data on Lubeluzole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lubeluzole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lubeluzole suppliers with USDMF on PharmaCompass.
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