01 1Finar
01 1AMMONIUM ACETATE HP PARENTEX PLUS
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37417
Submission : 2022-08-06
Status : Active
Type : IV
44
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A AcONH4 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AcONH4, including repackagers and relabelers. The FDA regulates AcONH4 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AcONH4 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 AcONH4 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A AcONH4 supplier is an individual or a company that provides AcONH4 active pharmaceutical ingredient (API) or AcONH4 finished formulations upon request. The AcONH4 suppliers may include AcONH4 API manufacturers, exporters, distributors and traders.
click here to find a list of AcONH4 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A AcONH4 DMF (Drug Master File) is a document detailing the whole manufacturing process of AcONH4 active pharmaceutical ingredient (API) in detail. Different forms of AcONH4 DMFs exist exist since differing nations have different regulations, such as AcONH4 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A AcONH4 DMF submitted to regulatory agencies in the US is known as a USDMF. AcONH4 USDMF includes data on AcONH4's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AcONH4 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of AcONH4 suppliers with USDMF on PharmaCompass.
