01 1Sifavitor srl
01 1PERHEXILINE MALEATE
01 1Italy
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28527
Submission : 2014-08-01
Status : Active
Type : II
A Perhexiline Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Perhexiline Maleate, including repackagers and relabelers. The FDA regulates Perhexiline Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Perhexiline Maleate 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 Perhexiline Maleate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Perhexiline Maleate supplier is an individual or a company that provides Perhexiline Maleate active pharmaceutical ingredient (API) or Perhexiline Maleate finished formulations upon request. The Perhexiline Maleate suppliers may include Perhexiline Maleate API manufacturers, exporters, distributors and traders.
click here to find a list of Perhexiline Maleate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Perhexiline Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Perhexiline Maleate active pharmaceutical ingredient (API) in detail. Different forms of Perhexiline Maleate DMFs exist exist since differing nations have different regulations, such as Perhexiline Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Perhexiline Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Perhexiline Maleate USDMF includes data on Perhexiline Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Perhexiline Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Perhexiline Maleate suppliers with USDMF on PharmaCompass.
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