01 1Johnson & Johnson Innovative Medicine
01 1LEVOCABASTINE HCL.(BULK)
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5847
Submission : 1985-04-19
Status : Inactive
Type : II
A Levocabastine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levocabastine, including repackagers and relabelers. The FDA regulates Levocabastine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levocabastine 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 Levocabastine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levocabastine supplier is an individual or a company that provides Levocabastine active pharmaceutical ingredient (API) or Levocabastine finished formulations upon request. The Levocabastine suppliers may include Levocabastine API manufacturers, exporters, distributors and traders.
click here to find a list of Levocabastine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levocabastine DMF (Drug Master File) is a document detailing the whole manufacturing process of Levocabastine active pharmaceutical ingredient (API) in detail. Different forms of Levocabastine DMFs exist exist since differing nations have different regulations, such as Levocabastine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levocabastine DMF submitted to regulatory agencies in the US is known as a USDMF. Levocabastine USDMF includes data on Levocabastine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levocabastine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levocabastine suppliers with USDMF on PharmaCompass.
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