01 1Salk Institute
01 1AZALINE B
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9672
Submission : 1992-05-08
Status : Inactive
Type : II
A Azaline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azaline, including repackagers and relabelers. The FDA regulates Azaline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azaline 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 Azaline supplier is an individual or a company that provides Azaline active pharmaceutical ingredient (API) or Azaline finished formulations upon request. The Azaline suppliers may include Azaline API manufacturers, exporters, distributors and traders.
click here to find a list of Azaline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Azaline DMF (Drug Master File) is a document detailing the whole manufacturing process of Azaline active pharmaceutical ingredient (API) in detail. Different forms of Azaline DMFs exist exist since differing nations have different regulations, such as Azaline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Azaline DMF submitted to regulatory agencies in the US is known as a USDMF. Azaline USDMF includes data on Azaline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Azaline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Azaline suppliers with USDMF on PharmaCompass.
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