01 1Johnson & Johnson Innovative Medicine
01 1AZAPERONE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10859
Submission : 1994-04-08
Status : Inactive
Type : II
A Azaperone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azaperone, including repackagers and relabelers. The FDA regulates Azaperone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azaperone 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 Azaperone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Azaperone supplier is an individual or a company that provides Azaperone active pharmaceutical ingredient (API) or Azaperone finished formulations upon request. The Azaperone suppliers may include Azaperone API manufacturers, exporters, distributors and traders.
click here to find a list of Azaperone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Azaperone DMF (Drug Master File) is a document detailing the whole manufacturing process of Azaperone active pharmaceutical ingredient (API) in detail. Different forms of Azaperone DMFs exist exist since differing nations have different regulations, such as Azaperone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Azaperone DMF submitted to regulatory agencies in the US is known as a USDMF. Azaperone USDMF includes data on Azaperone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Azaperone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Azaperone suppliers with USDMF on PharmaCompass.
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