01 1Chromo Laboratories
01 1ZIPRASIDONE MESILATE TRIHYDRATE
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36970
Submission : 2023-05-15
Status : Active
Type : II
A CHEBI:53757 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CHEBI:53757, including repackagers and relabelers. The FDA regulates CHEBI:53757 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CHEBI:53757 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 CHEBI:53757 supplier is an individual or a company that provides CHEBI:53757 active pharmaceutical ingredient (API) or CHEBI:53757 finished formulations upon request. The CHEBI:53757 suppliers may include CHEBI:53757 API manufacturers, exporters, distributors and traders.
click here to find a list of CHEBI:53757 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A CHEBI:53757 DMF (Drug Master File) is a document detailing the whole manufacturing process of CHEBI:53757 active pharmaceutical ingredient (API) in detail. Different forms of CHEBI:53757 DMFs exist exist since differing nations have different regulations, such as CHEBI:53757 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CHEBI:53757 DMF submitted to regulatory agencies in the US is known as a USDMF. CHEBI:53757 USDMF includes data on CHEBI:53757's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CHEBI:53757 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of CHEBI:53757 suppliers with USDMF on PharmaCompass.
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