01 1Johnson & Johnson Innovative Medicine
01 1CARISBAMAT (RWJ 333369)
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22019
Submission : 2008-10-22
Status : Inactive
Type : II
A Carisbamate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carisbamate, including repackagers and relabelers. The FDA regulates Carisbamate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carisbamate 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 Carisbamate supplier is an individual or a company that provides Carisbamate active pharmaceutical ingredient (API) or Carisbamate finished formulations upon request. The Carisbamate suppliers may include Carisbamate API manufacturers, exporters, distributors and traders.
click here to find a list of Carisbamate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Carisbamate DMF (Drug Master File) is a document detailing the whole manufacturing process of Carisbamate active pharmaceutical ingredient (API) in detail. Different forms of Carisbamate DMFs exist exist since differing nations have different regulations, such as Carisbamate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Carisbamate DMF submitted to regulatory agencies in the US is known as a USDMF. Carisbamate USDMF includes data on Carisbamate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Carisbamate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Carisbamate suppliers with USDMF on PharmaCompass.
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