01 1Urquima S.A. Grupo Uriach
01 1ALBACONAZOLE
01 1Spain
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28242
Submission : 2014-05-14
Status : Inactive
Type : II
A Albaconazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Albaconazole, including repackagers and relabelers. The FDA regulates Albaconazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Albaconazole 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 Albaconazole supplier is an individual or a company that provides Albaconazole active pharmaceutical ingredient (API) or Albaconazole finished formulations upon request. The Albaconazole suppliers may include Albaconazole API manufacturers, exporters, distributors and traders.
click here to find a list of Albaconazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Albaconazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Albaconazole active pharmaceutical ingredient (API) in detail. Different forms of Albaconazole DMFs exist exist since differing nations have different regulations, such as Albaconazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Albaconazole DMF submitted to regulatory agencies in the US is known as a USDMF. Albaconazole USDMF includes data on Albaconazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Albaconazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Albaconazole suppliers with USDMF on PharmaCompass.
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