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20-22 May, 2025
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22-25 April, 2025
AACR Annual meetingAACR Annual meeting
Industry Trade Show
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25-30 April, 2025
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[Sponsored by another company]https://www.pharmacompass.com/speak-pharma/our-unmatched-efficiency-and-track-record-of-faster-dmf-filings-give-our-customers-a-critical-competitive-advantage
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05 Jul 2018
// CONTRACT PHARMA
http://www.contractpharma.com/contents/view_breaking-news/2018-07-05/hybio-yf-capital-to-buy-amw/9778
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-16
Pay. Date : 2017-09-08
DMF Number : 31889
Submission : 2017-07-28
Status : Active
Type : II
Certificate Number : R0-CEP 2021-221 - Rev 00
Issue Date : 2022-11-14
Type : Chemical
Substance Number : 712
Status : Valid
NDC Package Code : 14403-0012
Start Marketing Date : 2022-04-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : (주)에스지바이오켐
Registration Date : 2022-03-25
Registration Number : 20220325-209-J-1254
Manufacturer Name : Hybio Pharmaceutical (Wuhan) Co., Ltd.
Manufacturer Address : No. 9 Linkong West Street, Hengdian Street, Huangpi District, Wuhan City, Hubei, China
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-08-04
Pay. Date : 2017-07-27
DMF Number : 30800
Submission : 2016-07-28
Status : Active
Type : II
Registration Number : 230MF10067
Registrant's Address : Hybio Medicine Park, No. 37, Keji C. 2nd St. Shenzhen High-tech Industrial Park, Guangdong, P. R. China 518057
Initial Date of Registration : 2018-05-31
Latest Date of Registration :
NDC Package Code : 14403-0011
Start Marketing Date : 2019-04-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
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 : 34916
Submission : 2020-07-20
Status : Active
Type : II
Certificate Number : CEP 2020-322 - Rev 01
Issue Date : 2024-01-17
Type : Chemical
Substance Number : 780
Status : Valid
NDC Package Code : 14403-0015
Start Marketing Date : 2022-11-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-12-01
Pay. Date : 2014-05-07
DMF Number : 26453
Submission : 2012-09-20
Status : Active
Type : II
NDC Package Code : 14403-0007
Start Marketing Date : 2014-06-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-07
Pay. Date : 2018-02-09
DMF Number : 28989
Submission : 2014-12-25
Status : Active
Type : II
NDC Package Code : 14403-0008
Start Marketing Date : 2025-01-24
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
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 : 32314
Submission : 2017-12-28
Status : Active
Type : II
NDC Package Code : 14403-0014
Start Marketing Date : 2022-11-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-08-01
Pay. Date : 2017-07-07
DMF Number : 30095
Submission : 2015-12-07
Status : Active
Type : II
NDC Package Code : 14403-0021
Start Marketing Date : 2025-03-13
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-04-05
Pay. Date : 2020-12-08
DMF Number : 35364
Submission : 2020-11-27
Status : Active
Type : II
NDC Package Code : 14403-0021
Start Marketing Date : 2024-12-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-07
Pay. Date : 2014-04-10
DMF Number : 27265
Submission : 2013-06-25
Status : Active
Type : II
NDC Package Code : 14403-0006
Start Marketing Date : 2014-06-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
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 : 34388
Submission : 2019-12-31
Status : Active
Type : II
NDC Package Code : 14403-0013
Start Marketing Date : 2022-05-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Complete
Rev. Date : 2024-01-08
Pay. Date : 2023-12-08
DMF Number : 39223
Submission : 2023-11-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25165
Submission : 2011-04-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39222
Submission : 2023-11-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-25
Pay. Date : 2022-05-18
DMF Number : 37082
Submission : 2022-04-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38904
Submission : 2023-09-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-16
Pay. Date : 2017-09-08
DMF Number : 31889
Submission : 2017-07-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-01
Pay. Date : 2014-05-07
DMF Number : 26453
Submission : 2012-09-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-04
Pay. Date : 2017-07-27
DMF Number : 30800
Submission : 2016-07-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-07
Pay. Date : 2018-02-09
DMF Number : 28989
Submission : 2014-12-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32314
Submission : 2017-12-28
Status : Active
Type : II
CEP/COS
Certificate Numbers : R0-CEP 2021-221 - Rev 00
Status : Valid
Issue Date : 2022-11-14
Type : Chemical
Substance Number : 712
CEP/COS
Certificate Numbers : CEP 2019-016 - Rev 01
Status : Valid
Issue Date : 2025-02-07
Type : Chemical
Substance Number : 1442
CEP/COS
Certificate Numbers : R0-CEP 2021-253 - Rev 00
Status : Valid
Issue Date : 2022-03-14
Type : Chemical
Substance Number : 2414
CEP/COS
Certificate Numbers : CEP 2020-322 - Rev 01
Status : Valid
Issue Date : 2024-01-17
Type : Chemical
Substance Number : 780
CEP/COS
Certificate Numbers : CEP 2024-027 - Rev 00
Status : Valid
Issue Date : 2024-08-29
Type : Chemical
Substance Number : 949
CEP/COS
Certificate Numbers : R0-CEP 2020-319 - Rev 00
Status : Valid
Issue Date : 2021-10-28
Type : Chemical
Substance Number : 2646
RLD : No
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : EPTIFIBATIDE
Dosage Strength : 2MG/ML
Approval Date : 2020-03-20
Application Number : 207864
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : EPTIFIBATIDE
Dosage Strength : 75MG/100ML
Approval Date : 2020-03-20
Application Number : 207864
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Inspections and registrations
ABOUT THIS PAGE
Hybio Pharmaceutical is a supplier offers 38 products (APIs, Excipients or Intermediates).
Find a price of Desmopressin Acetate bulk with DMF, CEP offered by Hybio Pharmaceutical
Find a price of Ganirelix bulk with DMF, JDMF offered by Hybio Pharmaceutical
Find a price of Oxytocin bulk with DMF, CEP offered by Hybio Pharmaceutical
Find a price of Abaloparatide Acetate bulk with DMF offered by Hybio Pharmaceutical
Find a price of Cannabidiol bulk with DMF offered by Hybio Pharmaceutical
Find a price of Cetrorelix Acetate bulk with DMF offered by Hybio Pharmaceutical
Find a price of Degarelix Acetate bulk with DMF offered by Hybio Pharmaceutical
Find a price of Eptifibatide bulk with DMF offered by Hybio Pharmaceutical
Find a price of Glatiramer Acetate bulk with DMF offered by Hybio Pharmaceutical
Find a price of Leuprolide Acetate bulk with CEP offered by Hybio Pharmaceutical
Find a price of Linaclotide bulk with DMF offered by Hybio Pharmaceutical
Find a price of Liraglutide bulk with DMF offered by Hybio Pharmaceutical
Find a price of Natriuretic Peptide, Brain bulk with DMF offered by Hybio Pharmaceutical
Find a price of Octreotide Acetate bulk with CEP offered by Hybio Pharmaceutical
Find a price of Semaglutide bulk with DMF offered by Hybio Pharmaceutical
Find a price of Somatostatin bulk with CEP offered by Hybio Pharmaceutical
Find a price of Teriparatide bulk with DMF offered by Hybio Pharmaceutical
Find a price of Terlipressin Acetate bulk with CEP offered by Hybio Pharmaceutical
Find a price of DEGARELIX ACETATE, NON-STERILE DRUG SUBSTANCE bulk with DMF offered by Hybio Pharmaceutical
Find a price of TIRZEPATIDE, NON-STERILE DRUG SUBSTANCE bulk with DMF offered by Hybio Pharmaceutical
Find a price of Bivalirudin bulk offered by Hybio Pharmaceutical
Find a price of Abaloparatide Acetate bulk offered by Hybio Pharmaceutical
Find a price of Atosiban bulk offered by Hybio Pharmaceutical
Find a price of Calcitonin bulk offered by Hybio Pharmaceutical
Find a price of Carbetocin Acetate bulk offered by Hybio Pharmaceutical
Find a price of Degarelix Acetate bulk offered by Hybio Pharmaceutical
Find a price of Desmopressin Acetate bulk offered by Hybio Pharmaceutical
Find a price of Exenatide bulk offered by Hybio Pharmaceutical
Find a price of Glatiramer Acetate bulk offered by Hybio Pharmaceutical
Find a price of Glucagon bulk offered by Hybio Pharmaceutical
Find a price of Liraglutide bulk offered by Hybio Pharmaceutical
Find a price of Plecanatide bulk offered by Hybio Pharmaceutical
Find a price of Retatrutide bulk offered by Hybio Pharmaceutical
Find a price of Semaglutide bulk offered by Hybio Pharmaceutical
Find a price of Thymalfasin bulk offered by Hybio Pharmaceutical
Find a price of Thyrotropin-Releasing Hormone bulk offered by Hybio Pharmaceutical
Find a price of Tirzepatide bulk offered by Hybio Pharmaceutical
Find a price of Ziconotide bulk offered by Hybio Pharmaceutical