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30 Sep 2021
// KOREAHERALD
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-15
Pay. Date : 2013-02-26
DMF Number : 20759
Submission : 2007-07-31
Status : Active
Type : II
Certificate Number : CEP 2007-252 - Rev 03
Issue Date : 2025-10-14
Type : Chemical
Substance Number : 2089
Status : Valid
Registration Number : 220MF10038
Registrant's Address : 8, Chungjeong-ro, Seodaemun-gu, Seoul, Republic of Korea
Initial Date of Registration : 2008-02-05
Latest Date of Registration :
NDC Package Code : 52972-0035
Start Marketing Date : 2007-09-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Chong Kun Dang Bio Co., Ltd.
Registration Date : 2013-04-03
Registration Number : 20130403-153-I-293-02
Manufacturer Name : Chong Kun Dang Bio Co., Ltd.
Manufacturer Address : (425-100) 292 Sinwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16427
Submission : 2003-01-21
Status : Active
Type : II
Certificate Number : CEP 2003-183 - Rev 05
Issue Date : 2025-08-06
Type : Chemical and TSE
Substance Number : 1140
Status : Valid
NDC Package Code : 52972-0042
Start Marketing Date : 2023-07-26
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (0.7kg/kg)
Marketing Category : DRUG FOR FURTHER PRO...
Registrant Name : Chong Kun Dang Bio Co., Ltd.
Registration Date : 2009-01-30
Registration Number : 20090130-113-F-32-06
Manufacturer Name : Chong Kun Dang Bio Co., Ltd._x000D_
Manufacturer Address : (425-100) 292 Sinwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do (368-3, Chungjeong-ro 3-ga, Seodaemun-gu, Seoul (120-756)) 455 Moknae-dong, Danwon-gu, Ansan-si, Gyeonggi-do

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-02
Pay. Date : 2013-06-11
DMF Number : 18362
Submission : 2005-04-14
Status : Active
Type : II
Certificate Number : R1-CEP 2005-180 - Rev 03
Issue Date : 2017-01-18
Type : Chemical and TSE
Substance Number : 1653
Status : Valid
NDC Package Code : 52972-0033
Start Marketing Date : 2005-06-10
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (0.5kg/kg)
Marketing Category : DRUG FOR FURTHER PRO...
Registrant Name : Chong Kun Dang Bio Co., Ltd.
Registration Date : 2009-01-30
Registration Number : 20090130-113-F-33-07
Manufacturer Name : Chong Kun Dang Bio Co., Ltd._x000D_
Manufacturer Address : (15604) 292 Sinwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do (368-3, Chungjeong-ro 3-ga, Seodaemun-gu, Seoul (120-756))

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-05
Pay. Date : 2013-09-26
DMF Number : 18363
Submission : 2005-04-14
Status : Active
Type : II
Certificate Number : R1-CEP 2005-178 - Rev 02
Issue Date : 2017-01-20
Type : Chemical and TSE
Substance Number : 1653
Status : Valid
NDC Package Code : 52972-0034
Start Marketing Date : 2005-06-10
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (0.5kg/kg)
Marketing Category : DRUG FOR FURTHER PRO...
Registrant Name : Chong Kun Dang Bio Co., Ltd.
Registration Date : 2009-01-30
Registration Number : 20090130-113-F-34-08
Manufacturer Name : Chong Kun Dang Bio Co., Ltd._x000D_
Manufacturer Address : (15604) 292 Sinwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do (368-3, Chungjeong-ro 3-ga, Seodaemun-gu, Seoul (120-756))

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12214
Submission : 1996-10-25
Status : Active
Type : II
Certificate Number : R1-CEP 2007-251 - Rev 02
Issue Date : 2021-08-26
Type : Chemical
Substance Number : 994
Status : Valid
NDC Package Code : 52972-0027
Start Marketing Date : 1996-11-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Chong Kun Dang Bio Co., Ltd.
Registration Date : 2019-07-02
Registration Number : 20190702-18-C-381-08
Manufacturer Name : Chong Kun Dang Bio Co., Ltd. @ Chong Kun Dang Bio Co., Ltd.
Manufacturer Address : 226, 101ho, 2-1dong, 3-1dong, 4dong, Sandan 3-gil, Sapgyo-eup, Yesan-gun, Chungcheongnam-do @ 292 Sinwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do.

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-04
Pay. Date : 2013-09-26
DMF Number : 13744
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 2015-313 - Rev 00
Issue Date : 2021-11-16
Type : Chemical
Substance Number : 176
Status : Valid
NDC Package Code : 52972-0030
Start Marketing Date : 1998-11-16
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34106
Submission : 2019-08-28
Status : Active
Type : II
Certificate Number : CEP 2019-321 - Rev 01
Issue Date : 2023-11-30
Type : Chemical
Substance Number : 2918
Status : Valid
Registrant Name : Chong Kun Dang Bio Co., Ltd.
Registration Date : 2020-07-07
Registration Number : 2253-5-ND
Manufacturer Name : Chong Kun Dang Bio Co., Ltd. @ ['Sirolimus' manufacturer] Zhejiang Wild Wind Pharmaceutical Co., Ltd
Manufacturer Address : 226, 101-ho, 2-1 building, 3-1 building, 4-dong, Sandan 3-gil, Sapgyo-eup, Yesan-gun, Chungcheongnam-do @ ['Sirolimus' Manufacturing Plant] Beijiang Industrial Zone, Geshan Town, Dongyann City, Zhejiang Province, China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23616
Submission : 2010-03-08
Status : Active
Type : II
Certificate Number : CEP 2010-035 - Rev 02
Issue Date : 2025-07-25
Type : Chemical
Substance Number : 432
Status : Valid
NDC Package Code : 52972-0036
Start Marketing Date : 2010-04-26
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31097
Submission : 2016-10-21
Status : Active
Type : II
Registration Number : 306MF10114
Registrant's Address : 8, Chungjeong-ro, Seodaemun-gu, Seoul, Republic of Korea
Initial Date of Registration : 2024-08-22
Latest Date of Registration :
NDC Package Code : 52972-0040
Start Marketing Date : 2016-09-29
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Chong Kun Dang Bio Co., Ltd.
Registration Date : 2022-05-24
Registration Number : 20220524-204-I-636-10
Manufacturer Name : Chong Kun Dang Bio Co., Ltd.
Manufacturer Address : 292 Sinwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do.

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2009-169 - Rev 03
Issue Date : 2021-12-14
Type : Chemical
Substance Number : 2358
Status : Valid
Registration Number : 304MF10085
Registrant's Address : 8, Chungjeong-ro, Seodaemun-gu, Seoul, Republic of Korea
Initial Date of Registration : 2022-06-08
Latest Date of Registration :
Registrant Name : Chong Kun Dang Bio Co., Ltd.
Registration Date : 2015-08-10
Registration Number : 20150810-63-A-323-09
Manufacturer Name : Chong Kun Dang Bio Co., Ltd.
Manufacturer Address : 292 Sinwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do

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CKD Bio Corporation is a supplier offers 35 products (APIs, Excipients or Intermediates).
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