ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 2ChemWerth Inc
02 1LGM Pharma
03 1Jai Radhe Sales
04 1Deccan Nutraceuticals Pvt. Ltd
05 1Medichem S.A
06 1ALP Pharm
07 1Aspen Biopharma Labs
08 1CARBOGEN AMCIS AG
09 1Curia
10 3Enaltec Labs Private Limited
11 1Global Calcium
12 1Hunan Huateng Pharmaceutical Co ltd
13 1Micro Labs Limited
14 1Pioneer Agro Extracts
15 1Precise Group
16 1Siegfried AG
17 1Varion Lifesciences
18 2Viatris
01 2China
02 11India
03 1Spain
04 2Switzerland
05 6U.S.A
01 8Active
02 14Blank
01 22Blank
01 1222MF10160
02 21Blank
01 1WC-0104A5-A6
02 1WC-0117
03 1WC-0174
04 1WC-0225
05 1WC-0424
06 1WC-0544
07 16Blank
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
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-09-22
Pay. Date : 2014-07-11
DMF Number : 28432
Submission : 2014-07-22
Status : Active
Type : II
NDC Package Code : 53296-0099
Start Marketing Date : 2009-12-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
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 : 22636
Submission : 2009-03-19
Status : Active
Type : II
NDC Package Code : 64181-0019
Start Marketing Date : 2005-08-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (6kg/6kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30593
Submission : 2016-06-21
Status : Active
Type : II
Date of Issue : 2022-06-22
Valid Till : 2025-07-28
Written Confirmation Number : WC-0117
Address of the Firm :
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 : 17812
Submission : 2004-11-03
Status : Active
Type : II
Registration Number : 222MF10160
Registrant's Address : Hauptstrasse 171, CH-4416 Bubendorf, Switzerland
Initial Date of Registration : 2010-05-31
Latest Date of Registration : --
NDC Package Code : 58567-104
Start Marketing Date : 2014-06-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23032
Submission : 2009-07-30
Status : Active
Type : II
Date of Issue : 2019-09-12
Valid Till : 2021-09-11
Written Confirmation Number : WC-0174
Address of the Firm :
Date of Issue : 2018-12-03
Valid Till : 2021-07-09
Written Confirmation Number : WC-0424
Address of the Firm :
NDC Package Code : 42413-0014
Start Marketing Date : 2017-11-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1.375kg/1.375kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-06-07
Valid Till : 2022-07-07
Written Confirmation Number : WC-0104A5-A6
Address of the Firm :
Date of Issue : 2019-08-16
Valid Till : 2022-08-15
Written Confirmation Number : WC-0225
Address of the Firm :
NDC Package Code : 42571-353
Start Marketing Date : 2019-06-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 42413-0014
Start Marketing Date : 2017-11-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1.375kg/1.375kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-12-16
Valid Till : 2025-12-15
Written Confirmation Number : WC-0544
Address of the Firm :
NDC Package Code : 42413-0014
Start Marketing Date : 2017-11-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1.375kg/1.375kg)
Marketing Category : BULK INGREDIENT
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.
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