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28-30 October, 2024
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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 : R1-CEP 2007-252 - Rev 02
Issue Date : 2017-01-27
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 : 2024-12-31
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 : R1-CEP 2005-180 - Rev 03
Issue Date : 2017-01-18
Type : Chemical and TSE
Substance Number : 1653
Status : Valid
NDC Package Code : 52972-0031
Start Marketing Date : 2003-02-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : 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 2005-178 - Rev 02
Issue Date : 2017-01-20
Type : Chemical and TSE
Substance Number : 1653
Status : Valid
NDC Package Code : 52972-0031
Start Marketing Date : 2003-02-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : 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 2003-183 - Rev 04
Issue Date : 2017-01-26
Type : Chemical and TSE
Substance Number : 1140
Status : Valid
NDC Package Code : 52972-0031
Start Marketing Date : 2003-02-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : 2024-12-31
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 : 2024-12-31
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' manufacturing plant] Zhejiang Wild Wind Pharmaceutical Co., Ltd
Manufacturer Address : 226, 101ho, 2-1dong, 3-1dong, 4dong, 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 : R1-CEP 2010-035 - Rev 01
Issue Date : 2016-11-04
Type : Chemical
Substance Number : 432
Status : Valid
NDC Package Code : 52972-0036
Start Marketing Date : 2010-04-26
End Marketing Date : 2024-12-31
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 : 2024-12-31
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
NDC Package Code : 52972-0035
Start Marketing Date : 2007-09-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52972-0033
Start Marketing Date : 2005-06-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (0.5kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 52972-0031
Start Marketing Date : 2003-02-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52972-0042
Start Marketing Date : 2023-07-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (0.7kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 52972-0034
Start Marketing Date : 2005-06-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (0.5kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 52972-0027
Start Marketing Date : 1996-11-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52972-0030
Start Marketing Date : 1998-11-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52972-0037
Start Marketing Date : 2011-06-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52972-0041
Start Marketing Date : 1998-11-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52972-0026
Start Marketing Date : 1998-11-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
About the Company : CKD BiO has positioned itself as a dedicated entity focusing on the development and manufacturing of high value-added products. This commitment is realized through trend-leading research and dev...
About the Company : CKD BiO has positioned itself as a dedicated entity focusing on the development and manufacturing of high value-added products. This commitment is realized through trend-leading research and dev...
About the Company : CKD BiO has positioned itself as a dedicated entity focusing on the development and manufacturing of high value-added products. This commitment is realized through trend-leading research and dev...
About the Company : CKD BiO has positioned itself as a dedicated entity focusing on the development and manufacturing of high value-added products. This commitment is realized through trend-leading research and dev...
About the Company : CKD BiO has positioned itself as a dedicated entity focusing on the development and manufacturing of high value-added products. This commitment is realized through trend-leading research and dev...
About the Company : CKD BiO has positioned itself as a dedicated entity focusing on the development and manufacturing of high value-added products. This commitment is realized through trend-leading research and dev...
Details:
CKDB-501A (serotype A botulinum toxin) is a novel BoNT/A neuromodulator protein. It is being evaluated for the treatment of moderate-to-severe glabellar lines.
Lead Product(s): Serotype A Botulinum Toxin
Therapeutic Area: Dermatology Brand Name: CKDB-501A
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Healis Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 27, 2024
Lead Product(s) : Serotype A Botulinum Toxin
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Healis Therapeutics
Deal Size : Not Applicable
Deal Type : Not Applicable
Healis Therapeutics Shares Phase III Topline Results for CKDB-501A Glabellar Injections
Details : CKDB-501A (serotype A botulinum toxin) is a novel BoNT/A neuromodulator protein. It is being evaluated for the treatment of moderate-to-severe glabellar lines.
Brand Name : CKDB-501A
Molecule Type : Large molecule
Upfront Cash : Not Applicable
February 27, 2024
Details:
Under the agreement, Healis intends to develop CKDB-501, a neuromodulator Serotype A botulinum toxin (BoNT/A) protein, for Major Depressive Disorder (MDD) and Post-Traumatic Stress Disorder (PTSD).
Lead Product(s): CKDB-501
Therapeutic Area: Psychiatry/Psychology Brand Name: CKDB-501
Study Phase: IND EnablingProduct Type: Large molecule
Sponsor: Healis Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 02, 2024
Lead Product(s) : CKDB-501
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : IND Enabling
Partner/Sponsor/Collaborator : Healis Therapeutics
Deal Size : Undisclosed
Deal Type : Agreement
Healis Announces Supply Agreement With CKD Bio To Develop CKDB-501
Details : Under the agreement, Healis intends to develop CKDB-501, a neuromodulator Serotype A botulinum toxin (BoNT/A) protein, for Major Depressive Disorder (MDD) and Post-Traumatic Stress Disorder (PTSD).
Brand Name : CKDB-501
Molecule Type : Large molecule
Upfront Cash : Undisclosed
January 02, 2024
Inspections and registrations
ABOUT THIS PAGE
CKD Bio Corporation is a supplier offers 22 products (APIs, Excipients or Intermediates).
Find a price of Acarbose bulk with DMF, CEP, JDMF offered by CKD Bio Corporation
Find a price of Clavulanic Acid bulk with DMF, CEP offered by CKD Bio Corporation
Find a price of Cyclosporine bulk with DMF, CEP offered by CKD Bio Corporation
Find a price of Demeclocycline Hydrochloride bulk with DMF, CEP offered by CKD Bio Corporation
Find a price of Everolimus bulk with DMF, CEP offered by CKD Bio Corporation
Find a price of Rifamycin Sodium bulk with DMF, CEP offered by CKD Bio Corporation
Find a price of Tacrolimus bulk with DMF, JDMF offered by CKD Bio Corporation
Find a price of Teicoplanin bulk with CEP, JDMF offered by CKD Bio Corporation
Find a price of Teicoplanin bulk with JDMF offered by CKD Bio Corporation
Find a price of Clavulanic Acid bulk with CEP offered by CKD Bio Corporation
Find a price of Daptomycin bulk with DMF offered by CKD Bio Corporation
Find a price of Peramivir bulk with DMF offered by CKD Bio Corporation
Find a price of Rifampicin bulk with DMF offered by CKD Bio Corporation
Find a price of Rifamycin bulk with DMF offered by CKD Bio Corporation
Find a price of Tacrolimus bulk with JDMF offered by CKD Bio Corporation
Find a price of Vancomycin Hydrochloride bulk offered by CKD Bio Corporation
Find a price of Mycophenolate Mofetil bulk offered by CKD Bio Corporation
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