ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Inke S.A
03 1LGM Pharma
04 1Synnat Pharma
05 1HRV Global Life Sciences
06 1Farmhispania
07 1Agno Pharma
08 1Alkaloids Corporation
09 1Apotex Pharmachem
10 1Aspire Lifesciences Pvt Ltd
11 1Centaur Pharmaceuticals
12 1CordenPharma
13 3Enaltec Labs Private Limited
14 1F. Hoffmann-La Roche
15 1Guangzhou Tosun Pharmaceutical
16 1H. Lundbeck AS
17 1Hasti Aria Shimi
18 1Hetero Drugs
19 1MSN Laboratories
20 1Piramal Pharma Solutions
21 1Recordati
22 1Rolabo Outsourcing
23 1Sun Pharmaceutical Industries Limited
24 2Viatris
01 1Canada
02 1China
03 1Denmark
04 1Germany
05 11India
06 1Iran
07 1Italy
08 3Spain
09 1Switzerland
10 6U.S.A
01 13Active
02 2Inactive
03 12Blank
01 27Blank
01 1224MF10075
02 26Blank
01 1WC-0040
02 1WC-0107
03 1WC-0117
04 1WC-0123
05 1WC-0159
06 1WC-0424
07 1WC-0544
08 20Blank
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 : 24946
Submission : 2011-10-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37218
Submission : 2022-06-21
Status : Active
Type : II
NDC Package Code : 64567-0025
Start Marketing Date : 2021-01-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-11-13
Pay. Date : 2018-09-27
DMF Number : 32450
Submission : 2018-01-17
Status : Active
Type : II
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0123
Address of the Firm :
NDC Package Code : 65085-0064
Start Marketing Date : 2018-12-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-01
Pay. Date : 2013-06-19
DMF Number : 27147
Submission : 2013-06-28
Status : Active
Type : II
Date of Issue : 2022-06-22
Valid Till : 2025-07-28
Written Confirmation Number : WC-0117
Address of the Firm :
NDC Package Code : 65015-831
Start Marketing Date : 2015-02-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-01-06
Pay. Date : 2015-10-06
DMF Number : 29828
Submission : 2015-10-09
Status : Active
Type : II
NDC Package Code : 63827-1013
Start Marketing Date : 2012-06-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10496
Submission : 1993-09-24
Status : Inactive
Type : II
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