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// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213382

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 : 2024-07-04
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : SG Biochem Co., Ltd.
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 : 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 : 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 : 2014-12-01
Pay. Date : 2014-05-07
DMF Number : 26453
Submission : 2012-09-20
Status : Active
Type : II

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
NDC Package Code : 14403-0011
Start Marketing Date : 2019-04-01
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 : 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 : 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 : 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 : 2025-12-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Otran Korea Co., Ltd.
Registration Date : 2025-04-25
Registration Number : 20250425-210-J-1880
Manufacturer Name : Hybio Pharmaceutical (Wuhan) Co., Ltd.
Manufacturer Address : No. 9 Linkong West Street, Hengdian Street, Huangpi District, Wuhan City, Hubei 430301, China

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 : 2025-12-12
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 : 2014-10-07
Pay. Date : 2014-04-10
DMF Number : 27265
Submission : 2013-06-25
Status : Active
Type : II

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 : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

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Hybio Pharmaceutical is a supplier offers 37 products (APIs, Excipients or Intermediates).
Find a price of Desmopressin Acetate bulk with DMF, CEP offered by Hybio Pharmaceutical
Find a price of Oxytocin bulk with DMF, CEP offered by Hybio Pharmaceutical
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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 Plecanatide bulk with DMF 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
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