01 1Erregierre SpA
01 1SULCONAZOLE NITRATE USP
01 1Italy
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14972
Submission : 2000-07-31
Status : Active
Type : II
A Sulconazole Nitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulconazole Nitrate, including repackagers and relabelers. The FDA regulates Sulconazole Nitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulconazole Nitrate 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 Sulconazole Nitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sulconazole Nitrate supplier is an individual or a company that provides Sulconazole Nitrate active pharmaceutical ingredient (API) or Sulconazole Nitrate finished formulations upon request. The Sulconazole Nitrate suppliers may include Sulconazole Nitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sulconazole Nitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sulconazole Nitrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sulconazole Nitrate active pharmaceutical ingredient (API) in detail. Different forms of Sulconazole Nitrate DMFs exist exist since differing nations have different regulations, such as Sulconazole Nitrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sulconazole Nitrate DMF submitted to regulatory agencies in the US is known as a USDMF. Sulconazole Nitrate USDMF includes data on Sulconazole Nitrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sulconazole Nitrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sulconazole Nitrate suppliers with USDMF on PharmaCompass.
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