01 1Johnson & Johnson Innovative Medicine
01 1LORCAINIDE HCL (JANSSEN CODE NO.R 15889
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5550
Submission : 1984-09-27
Status : Inactive
Type : II
A Lorcainide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lorcainide, including repackagers and relabelers. The FDA regulates Lorcainide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lorcainide 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 Lorcainide supplier is an individual or a company that provides Lorcainide active pharmaceutical ingredient (API) or Lorcainide finished formulations upon request. The Lorcainide suppliers may include Lorcainide API manufacturers, exporters, distributors and traders.
click here to find a list of Lorcainide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lorcainide DMF (Drug Master File) is a document detailing the whole manufacturing process of Lorcainide active pharmaceutical ingredient (API) in detail. Different forms of Lorcainide DMFs exist exist since differing nations have different regulations, such as Lorcainide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lorcainide DMF submitted to regulatory agencies in the US is known as a USDMF. Lorcainide USDMF includes data on Lorcainide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lorcainide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lorcainide suppliers with USDMF on PharmaCompass.
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