ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 2ChemWerth Inc
02 2Biophore India Pharmaceuticals Pvt Ltd
03 1Veranova
04 1Egis Pharmaceuticals PLC
05 2Neuland Laboratories
06 1Emcure Pharmaceuticals
07 3Enaltec Labs Private Limited
08 1Laboratorio Chimico Internazionale Spa
09 1Olon S.p.A
10 1Sai Life Sciences Limited
11 2Sionc Pharmaceuticals
12 1Solara Active Pharma Sciences
13 1Sunny Pharmtech
14 1TopChem Pharmaceuticals
15 1Viatris
16 1Zydus Lifesciences
01 1Hungary
02 13India
03 1Ireland
04 2Italy
05 1Taiwan
06 4U.S.A
01 14Active
02 1Inactive
03 7Blank
01 2Valid
02 20Blank
01 22Blank
01 1WC-0036
02 1WC-0037
03 1WC-0126
04 1WC-0226
05 1WC-0273
06 1WC-0424
07 16Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-27
Pay. Date : 2013-02-06
DMF Number : 26337
Submission : 2013-01-31
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-17
Pay. Date : 2015-09-08
DMF Number : 29429
Submission : 2015-06-06
Status : Active
Type : II
Certificate Number : R0-CEP 2018-288 - Rev 00
Issue Date : 2019-12-18
Type : Chemical
Substance Number : 457
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-08-15
Pay. Date : 2015-09-29
DMF Number : 29781
Submission : 2016-02-18
Status : Active
Type : II
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17193
Submission : 2004-02-26
Status : Active
Type : II
Certificate Number : R1-CEP 2004-053 - Rev 01
Issue Date : 2019-04-16
Type : Chemical
Substance Number : 457
Status : Valid
NDC Package Code : 48581-320
Start Marketing Date : 2020-04-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-15
Pay. Date : 2013-09-20
DMF Number : 27473
Submission : 2013-09-03
Status : Active
Type : II
Date of Issue : 2022-07-28
Valid Till : 2025-06-16
Written Confirmation Number : WC-0036
Address of the Firm :
NDC Package Code : 58032-1015
Start Marketing Date : 2013-11-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-25
Pay. Date : 2013-02-27
DMF Number : 26338
Submission : 2013-03-01
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-12-23
Pay. Date : 2016-09-21
DMF Number : 30813
Submission : 2016-09-19
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-06-16
Written Confirmation Number : WC-0037
Address of the Firm :
NDC Package Code : 58032-1015
Start Marketing Date : 2013-11-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-11-21
Pay. Date : 2017-10-18
DMF Number : 31925
Submission : 2017-10-23
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-10-31
Pay. Date : 2018-09-27
DMF Number : 32069
Submission : 2017-09-28
Status : Active
Type : II
Date of Issue : 2022-07-15
Valid Till : 2025-07-25
Written Confirmation Number : WC-0126
Address of the Firm :
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