01 1Emnar Pharma
02 1Zeria Pharmaceutical
01 1ACOTIAMIDE HYDROCHLORIDE
02 1ACOTIAMIDE HYDROCHLORIDE HYDRATE
01 1India
02 1Japan
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32458
Submission : 2018-01-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20144
Submission : 2007-01-12
Status : Inactive
Type : II
A Acotiamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acotiamide, including repackagers and relabelers. The FDA regulates Acotiamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acotiamide 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 Acotiamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Acotiamide supplier is an individual or a company that provides Acotiamide active pharmaceutical ingredient (API) or Acotiamide finished formulations upon request. The Acotiamide suppliers may include Acotiamide API manufacturers, exporters, distributors and traders.
click here to find a list of Acotiamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Acotiamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Acotiamide active pharmaceutical ingredient (API) in detail. Different forms of Acotiamide DMFs exist exist since differing nations have different regulations, such as Acotiamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acotiamide DMF submitted to regulatory agencies in the US is known as a USDMF. Acotiamide USDMF includes data on Acotiamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acotiamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Acotiamide suppliers with USDMF on PharmaCompass.
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