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