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01 1URAPIDIL
02 1URAPIDIL DRUG SUBSTANCE
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01 1Active
02 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38214
Submission : 2023-03-29
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4382
Submission : 1981-12-07
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Urapidil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Urapidil, including repackagers and relabelers. The FDA regulates Urapidil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Urapidil 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 Urapidil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Urapidil supplier is an individual or a company that provides Urapidil active pharmaceutical ingredient (API) or Urapidil finished formulations upon request. The Urapidil suppliers may include Urapidil API manufacturers, exporters, distributors and traders.
click here to find a list of Urapidil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Urapidil DMF (Drug Master File) is a document detailing the whole manufacturing process of Urapidil active pharmaceutical ingredient (API) in detail. Different forms of Urapidil DMFs exist exist since differing nations have different regulations, such as Urapidil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Urapidil DMF submitted to regulatory agencies in the US is known as a USDMF. Urapidil USDMF includes data on Urapidil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Urapidil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Urapidil suppliers with USDMF on PharmaCompass.
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