ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Cohance Lifesciences
03 1Bal Pharma
04 1Aspire Lifesciences Pvt Ltd
05 1Boehringer Ingelheim GmbH
06 1Chemipharm
07 2DNP Fine Chemicals
08 1Daito Pharmaceutical
09 1Daiwa Pharmaceuticals
10 1Hubei Haosun Pharmaceutical Co., Ltd.
11 1Icrom
12 4Jeil Pharmaceutical Co., Ltd
13 1Permachem Asia, Ltd
14 2Pharmacostech
15 1Sato Yakuhin Kogyo Co., Ltd
16 1Sun Pharmaceutical Industries Limited
17 1Trifarma
18 1Yuil Pharm
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02 1Egypt
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04 5India
05 2Italy
06 6Japan
07 6South Korea
08 1U.S.A
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01 6Active
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01 1Valid
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01 1217MF10409
02 1217MF11136
03 1218MF10959
04 1219MF10358
05 1220MF10235
06 1221MF10218
07 1222MF10021
08 1222MF10037
09 1224MF10100
10 1226MF10049
11 1226MF10231
12 1227MF10217
13 1229MF10196
14 1302MF10008
15 1302MF10108
16 1303MF10009
17 1305MF10001
18 7Blank
01 1WC-0150
02 1WC-0156
03 1WC-0168
04 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 : 21974
Submission : 2008-12-30
Status : Active
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Date of Issue : 2022-07-07
Valid Till : 2025-07-21
Written Confirmation Number : WC-0150
Address of the Firm :
Date of Issue : 2022-08-25
Valid Till : 2025-07-02
Written Confirmation Number : WC-0156
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22854
Submission : 2009-06-22
Status : Active
Type : II
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0168
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21851
Submission : 2008-08-01
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-05-27
Pay. Date : 2020-05-19
DMF Number : 21830
Submission : 2008-07-28
Status : Active
Type : II
Registration Number : 226MF10231
Registrant's Address : Via Delle Arti 33, 20863 Concorezzo (MB), Italy
Initial Date of Registration : 2014-12-08
Latest Date of Registration : --
Registrant Name : Insung Trading Co., Ltd.
Registration Date : 2019-05-27
Registration Number : 20130731-194-I-355-03(6)
Manufacturer Name : ICROM SpA
Manufacturer Address : Concorezzo(MB)-Via Delle Arti,33,Italy
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15003
Submission : 2000-09-11
Status : Active
Type : II
Certificate Number : R1-CEP 2011-311 - Rev 01
Issue Date : 2021-03-17
Type : Chemical
Substance Number : 2411
Status : Valid
Registration Number : 224MF10100
Registrant's Address : Binger Strasse 173,55216 Ingelheim am Rhein
Initial Date of Registration : 2012-05-23
Latest Date of Registration : --
Registrant Name : Boehringer Ingelheim Korea Ltd.
Registration Date : 2013-01-09
Registration Number : 20130109-194-I-63-01
Manufacturer Name : Boehringer Ingelheim GmbH & Co.KG
Manufacturer Address : Binger Strasse 173 55216 Ingelheim am Rhein, Germany
Registration Number : 218MF10959
Registrant's Address : 343, Sapyeong-daero, Seocho-gu, Seoul, Korea
Initial Date of Registration : 2006-12-01
Latest Date of Registration : --
Registrant Name : Jeil Pharmaceutical Co., Ltd.
Registration Date : 2013-02-15
Registration Number : 20130215-194-I-243-02
Manufacturer Name : Chongqing Succeway Pharmaceutical Co., Ltd. @Jeil Pharmaceutical Co., Ltd. @[Starting material (epinastin bromide) manufacturer①] Pharmacostec Co., Ltd. @[Starting material (epinastin bromide) manufacturer②] Dong-in Chemical Co., Ltd. @[Starting material
Manufacturer Address : Chongqing Jinlong Industrial District, China@7 Cheonggang-ga-chang-ro, Baekam-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do (B-dong, etc.)@47 Yakjedanji-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do@62 Sandan-ro 16beon-gil, Pyeongtaek-si, Gyeonggi-do@204 Sandan-gil, Jeonui-myeon, Sejong Special Self-Governing City
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40256
Submission : 2024-08-07
Status : Active
Type : II
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