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
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A Myk manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Myk, including repackagers and relabelers. The FDA regulates Myk manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Myk 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 Myk manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Myk supplier is an individual or a company that provides Myk active pharmaceutical ingredient (API) or Myk finished formulations upon request. The Myk suppliers may include Myk API manufacturers, exporters, distributors and traders.
click here to find a list of Myk suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Myk DMF (Drug Master File) is a document detailing the whole manufacturing process of Myk active pharmaceutical ingredient (API) in detail. Different forms of Myk DMFs exist exist since differing nations have different regulations, such as Myk USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Myk DMF submitted to regulatory agencies in the US is known as a USDMF. Myk USDMF includes data on Myk's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Myk USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Myk suppliers with USDMF on PharmaCompass.
