ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1ALP Pharm
03 4BrightGene Bio-Medical Technology Co.,Ltd
04 1Curia
05 1Emcure Pharmaceuticals
06 2GLAND PHARMA LIMITED
07 1Guangzhou Tosun Pharmaceutical
08 1H. Lundbeck AS
09 1Hameln rds
10 1Jiangsu Lianhuan Pharmaceutical
11 1KIVIPharm
12 2KOLON Life Science, Inc
13 1Lunan Pharmaceutical
14 1Mitsubishi Tanabe Pharma
15 1Sailong Pharmaceutical
16 1ScinoPharm Taiwan, Ltd
17 1Sms Lifesciences
18 1Tianjin Weijie Pharmaceutical Co., Ltd.
01 11China
02 1Denmark
03 4India
04 1Japan
05 1Slovakia
06 2South Korea
07 1Taiwan
08 2U.S.A
01 8Active
02 2Inactive
03 13Blank
01 23Blank
01 1218MF10153
02 1230MF10028
03 1302MF10033
04 1303MF10076
05 1304MF10018
06 1305MF10140
07 17Blank
01 1WC-0226
02 1WC-0427A3-4
03 21Blank
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 : 31131
Submission : 2016-12-05
Status : Active
Type : II
NDC Package Code : 17223-0003
Start Marketing Date : 2014-07-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25765
Submission : 2012-03-19
Status : Active
Type : II
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0226
Address of the Firm :
NDC Package Code : 14593-851
Start Marketing Date : 2023-12-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-05
Pay. Date : 2013-09-26
DMF Number : 21304
Submission : 2008-01-30
Status : Active
Type : II
NDC Package Code : 45562-1124
Start Marketing Date : 2005-12-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25893
Submission : 2012-02-20
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-12
Pay. Date : 2013-03-26
DMF Number : 25400
Submission : 2011-10-27
Status : Active
Type : II
Date of Issue : 2022-08-04
Valid Till : 2025-03-04
Written Confirmation Number : WC-0427A3-4
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-12-15
Pay. Date : 2014-11-28
DMF Number : 28030
Submission : 2014-05-15
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-10-01
Pay. Date : 2021-04-14
DMF Number : 35491
Submission : 2020-12-26
Status : Active
Type : II
Registration Number : 305MF10140
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China 215123
Initial Date of Registration : 2023-12-22
Latest Date of Registration : --
NDC Package Code : 62227-015
Start Marketing Date : 2018-01-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (2kg/2kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7801
Submission : 1988-12-08
Status : Inactive
Type : II
Registrant Name : Mitsubishi Tanabe Pharma Korea Co., Ltd.
Registration Date : 2022-01-21
Registration Number : 20220121-210-J-1219
Manufacturer Name : Mitsubishi Tanabe Pharma Factory Ltd., Onoda Plant
Manufacturer Address : 7473-2, Ooaza Onoda, SanyoOnoda,Yamaguchi, 756-0054, Japan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22935
Submission : 2009-07-10
Status : Inactive
Type : II
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