01 1Actavis Inc
02 1Juzen Chemical Corporation
03 1Siegfried AG
04 1Blank
01 1OXYBUTYNIN
02 3OXYBUTYNIN BASE
01 1Ireland
02 1Japan
03 1Switzerland
04 1Blank
01 2Active
02 2Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26077
Submission : 2012-06-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14071
Submission : 1999-03-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11947
Submission : 1996-04-26
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11478
Submission : 1995-04-27
Status : Inactive
Type : II
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A Oxybutynin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxybutynin, including repackagers and relabelers. The FDA regulates Oxybutynin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxybutynin 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 Oxybutynin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxybutynin supplier is an individual or a company that provides Oxybutynin active pharmaceutical ingredient (API) or Oxybutynin finished formulations upon request. The Oxybutynin suppliers may include Oxybutynin API manufacturers, exporters, distributors and traders.
click here to find a list of Oxybutynin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxybutynin DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxybutynin active pharmaceutical ingredient (API) in detail. Different forms of Oxybutynin DMFs exist exist since differing nations have different regulations, such as Oxybutynin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxybutynin DMF submitted to regulatory agencies in the US is known as a USDMF. Oxybutynin USDMF includes data on Oxybutynin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxybutynin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxybutynin suppliers with USDMF on PharmaCompass.
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