01 1Kissei Pharmaceutical
02 1Shiono Finesse
01 1KAD-1229
02 1KAD-1229 DRUG SUBSTANCE
01 2Japan
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12834
Submission : 1998-01-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14812
Submission : 2000-03-31
Status : Inactive
Type : II
A Mitiglinide Calcium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mitiglinide Calcium, including repackagers and relabelers. The FDA regulates Mitiglinide Calcium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mitiglinide Calcium 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 Mitiglinide Calcium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mitiglinide Calcium supplier is an individual or a company that provides Mitiglinide Calcium active pharmaceutical ingredient (API) or Mitiglinide Calcium finished formulations upon request. The Mitiglinide Calcium suppliers may include Mitiglinide Calcium API manufacturers, exporters, distributors and traders.
click here to find a list of Mitiglinide Calcium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mitiglinide Calcium DMF (Drug Master File) is a document detailing the whole manufacturing process of Mitiglinide Calcium active pharmaceutical ingredient (API) in detail. Different forms of Mitiglinide Calcium DMFs exist exist since differing nations have different regulations, such as Mitiglinide Calcium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mitiglinide Calcium DMF submitted to regulatory agencies in the US is known as a USDMF. Mitiglinide Calcium USDMF includes data on Mitiglinide Calcium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mitiglinide Calcium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mitiglinide Calcium suppliers with USDMF on PharmaCompass.
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