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16 Jun 2025
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Latest Content by PharmaCompass
KEY PRODUCTS
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01 1Abaloparatide
02 1Cagrilintide
03 1Ecnoglutide
04 1Etelcalcetide
05 1Icotrokinra
06 1Mazdutide
07 1Orforglipron Calcium Hydrate
08 1Retatrutide
09 4Semaglutide
10 1Survodutide
11 1Tirzepatide
12 1Blank
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01 8Active
02 7Blank
01 15Blank
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01 15Blank
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01 15Blank
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01 120250619-210-J-1943
02 120250619-210-J-1943(A)
03 1Su582-41-ND
04 12Blank
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01 184502-101
02 184502-103
03 184502-108
04 184502-109
05 184502-113
06 10Blank
01 15Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42393
Submission : 2025-09-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42392
Submission : 2025-08-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39522
Submission : 2024-03-07
Status : Active
Type : II
NDC Package Code : 84502-113
Start Marketing Date : 2026-05-19
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea Biochem Pharmaceutical Co., Ltd.
Registration Date : 2025-07-09
Registration Number : 20250619-210-J-1943(A)
Manufacturer Name : Fujian Genohope Biotech Ltd.
Manufacturer Address : No. 288 Renyang, Binglun Village, Hushi Town Xiuyu District Putian, Fujian 351146, China
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-07-08
Pay. Date : 2025-05-15
DMF Number : 39932
Submission : 2024-05-16
Status : Active
Type : II
NDC Package Code : 84502-108
Start Marketing Date : 2025-10-17
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Rihu Healthcare Co., Ltd.
Registration Date : 2025-06-19
Registration Number : 20250619-210-J-1943
Manufacturer Name : Fujian Genohope Biotech Ltd.
Manufacturer Address : No. 288, Renyang, Binglun Village, Hushi Town, Xiuyu District, Putian, Fujian 351146, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40957
Submission : 2024-12-09
Status : Active
Type : II
NDC Package Code : 84502-109
Start Marketing Date : 2025-10-17
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-11-17
Pay. Date : 2025-09-19
DMF Number : 42491
Submission : 2025-09-30
Status : Active
Type : II
NDC Package Code : 84502-101
Start Marketing Date : 2024-07-02
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40503
Submission : 2024-09-19
Status : Active
Type : II
NDC Package Code : 84502-103
Start Marketing Date : 2024-07-31
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Sampung Pharmachem Co., Ltd.
Registration Date : 2026-05-03
Registration Number : Su582-41-ND
Manufacturer Name : Fujian Genohope Biotech Ltd.
Manufacturer Address : No. 288 Renyang, Binglun Village, Hushi Town Xiuyu District Putian, Fujian 351146, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41652
Submission : 2025-05-20
Status : Active
Type : II
Fujian Genohope Biotech is a supplier offers 12 products (APIs, Excipients or Intermediates).
Find Orforglipron Calcium Hydrate bulk with DMF offered by Fujian Genohope Biotech
Find Retatrutide bulk with DMF offered by Fujian Genohope Biotech
Find Semaglutide bulk with DMF offered by Fujian Genohope Biotech
Find Tirzepatide bulk with DMF offered by Fujian Genohope Biotech
Find PREFILLED SYRINGE OF STERILE WATER FOR INJECTION, 1 ML, USP bulk with DMF offered by Fujian Genohope Biotech
Find Abaloparatide bulk offered by Fujian Genohope Biotech
Find Cagrilintide bulk offered by Fujian Genohope Biotech
Find Ecnoglutide bulk offered by Fujian Genohope Biotech
Find Etelcalcetide bulk offered by Fujian Genohope Biotech
Find Icotrokinra bulk offered by Fujian Genohope Biotech
Find Mazdutide bulk offered by Fujian Genohope Biotech
Find Survodutide bulk offered by Fujian Genohope Biotech