01 2Archimica
02 1Blank
01 1PIRENZEPINE BASE PURE
02 2PIRENZEPINE DIHYDROCHLORIDE
01 2Italy
02 1Blank
01 2Active
02 1Inactive
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33591
Submission : 2019-06-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13831
Submission : 1998-11-05
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10924
Submission : 1994-05-24
Status : Inactive
Type : II
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A Pirenzepine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pirenzepine, including repackagers and relabelers. The FDA regulates Pirenzepine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pirenzepine 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 Pirenzepine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pirenzepine supplier is an individual or a company that provides Pirenzepine active pharmaceutical ingredient (API) or Pirenzepine finished formulations upon request. The Pirenzepine suppliers may include Pirenzepine API manufacturers, exporters, distributors and traders.
click here to find a list of Pirenzepine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pirenzepine DMF (Drug Master File) is a document detailing the whole manufacturing process of Pirenzepine active pharmaceutical ingredient (API) in detail. Different forms of Pirenzepine DMFs exist exist since differing nations have different regulations, such as Pirenzepine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pirenzepine DMF submitted to regulatory agencies in the US is known as a USDMF. Pirenzepine USDMF includes data on Pirenzepine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pirenzepine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pirenzepine suppliers with USDMF on PharmaCompass.
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