01 2Amoli Organics
02 1Amsa Spa
03 1Assertio Therapeutics
04 1COSMA S.p.A
05 2J.B.Chemicals & Pharmaceuticals
06 1YUNG ZIP CHEMICAL INDUSTRIAL
01 1DICLOFENAC
02 2DICLOFENAC ACID
03 1DICLOFENAC DIETHYAMINE
04 1DICLOFENAC DIETHYLAMINE
05 2DICLOFENAC HYDROXY ETHYL PYRROLIDINE
06 1ZORVOLEX® (DICLOFENAC) CAPSULES
01 4India
02 2Italy
03 1Taiwan
04 1U.S.A
01 8Active
01 2Complete
02 6Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-12
Pay. Date : 2014-05-19
DMF Number : 28208
Submission : 2014-04-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23680
Submission : 2010-03-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14831
Submission : 2000-04-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26224
Submission : 2012-12-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27322
Submission : 2014-03-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-11
Pay. Date : 2014-09-04
DMF Number : 15366
Submission : 2001-04-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19020
Submission : 2006-01-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25107
Submission : 2011-06-30
Status : Active
Type : II
A Cataflam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cataflam, including repackagers and relabelers. The FDA regulates Cataflam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cataflam 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 Cataflam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cataflam supplier is an individual or a company that provides Cataflam active pharmaceutical ingredient (API) or Cataflam finished formulations upon request. The Cataflam suppliers may include Cataflam API manufacturers, exporters, distributors and traders.
click here to find a list of Cataflam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cataflam DMF (Drug Master File) is a document detailing the whole manufacturing process of Cataflam active pharmaceutical ingredient (API) in detail. Different forms of Cataflam DMFs exist exist since differing nations have different regulations, such as Cataflam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cataflam DMF submitted to regulatory agencies in the US is known as a USDMF. Cataflam USDMF includes data on Cataflam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cataflam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cataflam suppliers with USDMF on PharmaCompass.
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