01 1COSMA S.p.A
02 1China Chemical & Pharmaceutical
03 1Cilag AG
04 1Corden Pharma Bergamo S.p.A
05 1Erregierre SpA
06 1Katwijk Chemie
07 1Olon S.p.A
08 1SIMS Srl
09 1Sumitomo Chemical
10 1Zambon Group SpA
01 8OXAPROZIN
02 1OXAPROZIN (BULK ACTIVE PHARMACEUTICAL INGREDIENT)
03 1OXAPROZIN JP
01 1China
02 6Italy
03 1Japan
04 1Netherlands
05 1Switzerland
01 3Active
02 7Inactive
01 1Complete
02 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13119
Submission : 1998-08-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11867
Submission : 1996-02-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12340
Submission : 1997-01-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12999
Submission : 1998-05-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14059
Submission : 1999-04-05
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-26
Pay. Date : 2014-12-29
DMF Number : 11308
Submission : 1995-01-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12911
Submission : 1998-03-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15484
Submission : 2001-06-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11748
Submission : 1995-11-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13227
Submission : 1998-09-21
Status : Inactive
Type : II
A Oxaprozin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxaprozin, including repackagers and relabelers. The FDA regulates Oxaprozin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxaprozin 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 Oxaprozin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxaprozin supplier is an individual or a company that provides Oxaprozin active pharmaceutical ingredient (API) or Oxaprozin finished formulations upon request. The Oxaprozin suppliers may include Oxaprozin API manufacturers, exporters, distributors and traders.
click here to find a list of Oxaprozin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxaprozin DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxaprozin active pharmaceutical ingredient (API) in detail. Different forms of Oxaprozin DMFs exist exist since differing nations have different regulations, such as Oxaprozin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxaprozin DMF submitted to regulatory agencies in the US is known as a USDMF. Oxaprozin USDMF includes data on Oxaprozin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxaprozin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxaprozin suppliers with USDMF on PharmaCompass.
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