01 1Apotex Pharmachem
02 1Servier
01 2PERINDOPRIL ARGININE
01 1Canada
02 1France
01 2Active
01 1Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2016-11-18
Pay. Date : 2016-08-24
DMF Number : 30810
Submission : 2016-08-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27822
Submission : 2014-01-21
Status : Active
Type : II
A Perindopril Arginine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Perindopril Arginine, including repackagers and relabelers. The FDA regulates Perindopril Arginine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Perindopril Arginine 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 Perindopril Arginine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Perindopril Arginine supplier is an individual or a company that provides Perindopril Arginine active pharmaceutical ingredient (API) or Perindopril Arginine finished formulations upon request. The Perindopril Arginine suppliers may include Perindopril Arginine API manufacturers, exporters, distributors and traders.
click here to find a list of Perindopril Arginine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Perindopril Arginine DMF (Drug Master File) is a document detailing the whole manufacturing process of Perindopril Arginine active pharmaceutical ingredient (API) in detail. Different forms of Perindopril Arginine DMFs exist exist since differing nations have different regulations, such as Perindopril Arginine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Perindopril Arginine DMF submitted to regulatory agencies in the US is known as a USDMF. Perindopril Arginine USDMF includes data on Perindopril Arginine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Perindopril Arginine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Perindopril Arginine suppliers with USDMF on PharmaCompass.
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