01 1Daiichi Sankyo
02 1Nihon Nohyaku
01 1MALOTILATE
02 1MALOTILATE 200 MG TABLETS
01 2Japan
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5347
Submission : 1984-05-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5356
Submission : 1984-05-03
Status : Inactive
Type : II
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PharmaCompass offers a list of MALOTILATE API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right MALOTILATE manufacturer or MALOTILATE supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred MALOTILATE manufacturer or MALOTILATE supplier.
A MALOTILATE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MALOTILATE, including repackagers and relabelers. The FDA regulates MALOTILATE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MALOTILATE 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 MALOTILATE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A MALOTILATE supplier is an individual or a company that provides MALOTILATE active pharmaceutical ingredient (API) or MALOTILATE finished formulations upon request. The MALOTILATE suppliers may include MALOTILATE API manufacturers, exporters, distributors and traders.
click here to find a list of MALOTILATE suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A MALOTILATE DMF (Drug Master File) is a document detailing the whole manufacturing process of MALOTILATE active pharmaceutical ingredient (API) in detail. Different forms of MALOTILATE DMFs exist exist since differing nations have different regulations, such as MALOTILATE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MALOTILATE DMF submitted to regulatory agencies in the US is known as a USDMF. MALOTILATE USDMF includes data on MALOTILATE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MALOTILATE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of MALOTILATE suppliers with USDMF on PharmaCompass.
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