ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 2ChemWerth Inc
02 1Medichem S.A
03 1ALP Pharm
04 1CARBOGEN AMCIS AG
05 1Curia
06 2Viatris
01 4NEPAFENAC
02 1NEPAFENAC (STERILE)
03 1NEPAFENAC DRUG SUBSTANCE
04 1NEPAFENAC, NON-STERILE BULK DRUG SUBSTANCE
05 1NEPAFENAC, STERILE BULK DRUG SUBSTANCE
01 1China
02 1Spain
03 1Switzerland
04 5U.S.A
01 8Active
01 1Complete
02 7Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25528
Submission : 2014-12-17
Status : Active
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-22
Pay. Date : 2014-07-11
DMF Number : 28432
Submission : 2014-07-22
Status : Active
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28205
Submission : 2015-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23032
Submission : 2009-07-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17812
Submission : 2004-11-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22636
Submission : 2009-03-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30594
Submission : 2016-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30593
Submission : 2016-06-21
Status : Active
Type : II
A Nepafenac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nepafenac, including repackagers and relabelers. The FDA regulates Nepafenac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nepafenac 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 Nepafenac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nepafenac supplier is an individual or a company that provides Nepafenac active pharmaceutical ingredient (API) or Nepafenac finished formulations upon request. The Nepafenac suppliers may include Nepafenac API manufacturers, exporters, distributors and traders.
click here to find a list of Nepafenac suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nepafenac DMF (Drug Master File) is a document detailing the whole manufacturing process of Nepafenac active pharmaceutical ingredient (API) in detail. Different forms of Nepafenac DMFs exist exist since differing nations have different regulations, such as Nepafenac USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nepafenac DMF submitted to regulatory agencies in the US is known as a USDMF. Nepafenac USDMF includes data on Nepafenac's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nepafenac USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nepafenac suppliers with USDMF on PharmaCompass.
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