ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1HRV Global Life Sciences
03 1Olpha
04 1Amsa Spa
05 1Ash Stevens, Inc.
06 1CPL Sachse
07 2Cipla
08 1Mehta API
09 1Micro Labs Limited
10 1Piramal Pharma Solutions
11 1Torrent Pharmaceuticals Limited
12 1Zydus Lifesciences
13 1Blank
01 1Germany
02 7India
03 1Italy
04 1Latvia
05 3U.S.A
06 1Blank
01 8Active
02 2Inactive
03 4Blank
01 14Blank
01 14Blank
01 1WC-0113-A3
02 1WC-0113A3
03 1WC-0214
04 11Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16440
Submission : 2003-02-25
Status : Active
Type : II
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17041
Submission : 2003-12-16
Status : Active
Type : II
NDC Package Code : 63818-0425
Start Marketing Date : 2017-07-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38181
Submission : 2023-05-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15971
Submission : 2002-05-06
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-11-14
Pay. Date : 2014-06-11
DMF Number : 16531
Submission : 2003-03-30
Status : Active
Type : II
NDC Package Code : 65841-106
Start Marketing Date : 2024-09-18
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 : 16024
Submission : 2002-06-24
Status : Active
Type : II
Date of Issue : 2020-03-20
Valid Till : 2022-08-08
Written Confirmation Number : WC-0113-A3
Address of the Firm :
NDC Package Code : 53104-7537
Start Marketing Date : 2018-07-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (0.4kg/.4kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea Phambio Co., Ltd.
Registration Date : 2018-11-14
Registration Number : No. 4838-7-ND(2)
Manufacturer Name : Cipla Limited
Manufacturer Address : Virgonagar Post, Old Madras Road, Bangalore-560 049, INDIA
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-02
Pay. Date : 2015-06-30
DMF Number : 29475
Submission : 2015-07-13
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-06-23
Pay. Date : 2022-06-08
DMF Number : 37180
Submission : 2022-06-01
Status : Active
Type : II
NDC Package Code : 42571-413
Start Marketing Date : 2022-03-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16969
Submission : 2003-11-12
Status : Inactive
Type : II
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