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01 1Aminolevulinic Acid HCl
02 1Arginine Vasopressin
03 1Atosiban
04 1Bivalirudin
05 1Buserelin Acetate
06 2Calcitonin
07 2Carbidopa
08 1Corticotropin
09 1Dasiglucagon
10 1Desmopressin Acetate
11 2Etomidate
12 1Exenatide
13 2Glucagon
14 1Glucagon Hydrochloride
15 1Gonadorelin Acetate
16 2Goserelin Acetate
17 1Histrelin Acetate
18 1Icatibant Acetate
19 1Lanreotide Acetate
20 1Leuprolide Acetate
21 1Leuprolide Mesylate
22 2Liraglutide
23 1N-T-Boc-2,5-Dihydropyrrole
24 3Octreotide Acetate
25 1Propofol
26 1Semaglutide
27 1Sincalide
28 1Somatostatin
29 1Teriparatide
30 1Teriparatide Acetate
31 1Tetracosactide
32 1Trans-3-Hexenyl Acetate
33 1Triptorelin Acetate
34 1Triptorelin Pamoate
35 1Vasoactive Intestinal Peptide
36 2Blank
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01 35Active
02 1Inactive
03 9Blank
01 13Valid
02 32Blank
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01 1218MF10708
02 1218MF10953
03 1221MF10007
04 1222MF10137
05 1222MF10146
06 1225MF10159
07 1226MF10051
08 1228MF10213
09 1229MF10071
10 1231MF10022
11 1304MF10160
12 1306MF10083
13 33Blank
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01 45Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-03-27
Pay. Date : 2015-03-18
DMF Number : 6504
Submission : 1986-07-29
Status : Active
Type : II
Certificate Number : R1-CEP 2000-180 - Rev 01
Issue Date : 2008-08-01
Type : Chemical
Substance Number : 471
Status : Valid
Registration Number : 218MF10953
Registrant's Address : 3132 Kashiwa Street, Torrance, California 90505, USA
Initial Date of Registration : 2006-11-24
Latest Date of Registration :
NDC Package Code : 52416-111
Start Marketing Date : 2009-06-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-11
Pay. Date : 2013-06-17
DMF Number : 9231
Submission : 1991-07-11
Status : Active
Type : II
Certificate Number : R1-CEP 2000-012 - Rev 08
Issue Date : 2019-12-16
Type : Chemical
Substance Number : 755
Status : Valid
Registration Number : 222MF10146
Registrant's Address : Route du simplon 22, CH-1895 Vionnaz-Switzerland
Initial Date of Registration : 2010-04-22
Latest Date of Registration :
NDC Package Code : 51504-0001
Start Marketing Date : 1991-07-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2021-03-03
Registration Number : 20210303-211-J-655
Manufacturer Name : Bachem SA
Manufacturer Address : Succursale of Vionnaz, Route du Simplon 22, 1895 Vionnaz, Switzerland