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01 1Abrocitinib
02 1Acalabrutinib
03 2Allopurinol
04 1Amlodipine Besylate
05 1Avapritinib
06 1Bisoprolol Fumarate
07 1Blarcamesine
08 1Capivasertib
09 1Carvedilol
10 1Chlorpromazine Hydrochloride
11 1Clomiphene Citrate
12 1Crotamiton
13 1Dabrafenib Mesylate
14 1Dapagliflozin Propanediol Monohydrate
15 1Darolutamide
16 1Deucravacitinib
17 1Donepezil
18 1Duloxetine Hydrochloride
19 1Empagliflozin
20 1Ethacrynic Acid
21 1Etrasimod
22 1Fezolinetant
23 1Ketoprofen
24 1LCZ 696
25 1Levocetirizine Dihydrochloride
26 2Levomepromazine Maleate
27 1Mavacamten
28 1Methyldopa
29 1Nifedipine
30 1Niraparib Tosylate
31 1Nitrendipine
32 1Osimertinib Mesylate
33 1Ozanimod
34 1Promethazine Hydrochloride
35 1Quetiapine Hemifumarate
36 1Ramipril
37 1Repotrectinib
38 1Resmetirom
39 1Ribociclib
40 1Rivaroxaban
41 2Tofisopam
42 1Troriluzole
43 1Upadacitinib
44 1Zanubrutinib
45 1Blank
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01 3Active
02 45Blank
01 12Valid
02 36Blank
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01 1219MF10297
02 1231MF10077
03 1304MF10157
04 1307MF10033
05 44Blank
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01 48Blank
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01 120050831-64-C-192-03
02 120050831-64-C-192-03(1)
03 120160323-130-H-293-45
04 120210125-209-J-511
05 44Blank
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01 148581-114
02 148581-320
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01 48Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-06-10
Pay. Date : 2021-06-07
DMF Number : 7882
Submission : 1989-01-24
Status : Active
Type : II
Certificate Number : R1-CEP 2008-279 - Rev 02
Issue Date : 2023-01-12
Type : Chemical
Substance Number : 524
Status : Valid
Registration Number : 307MF10033
Registrant's Address : H-1106 BUDAPEST KERESZTURI UT 30-38 HUNGARY
Initial Date of Registration : 2025-02-07
Latest Date of Registration :
NDC Package Code : 48581-114
Start Marketing Date : 2007-05-04
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg. Filing : BR |
Certificate Number : R1-CEP 1996-032 - Rev 05
Issue Date : 2019-08-09
Type : Chemical
Substance Number : 576
Status : Valid
Registration Number : 231MF10077
Registrant's Address : H-1106 BUDAPEST KERESZTURI UT 30-38 HUNGARY
Initial Date of Registration : 2019-03-29
Latest Date of Registration :
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2021-01-25
Registration Number : 20210125-209-J-511
Manufacturer Name : EGIS Pharmaceuticals Plc.
Manufacturer Address : Kereszturi ut 30-38., Budapest, 1106, Hungary
Certificate Number : R1-CEP 1996-077 - Rev 07
Issue Date : 2021-10-15
Type : Chemical
Substance Number : 475
Status : Valid
Registration Number : 304MF10157
Registrant's Address : H-1106 BUDAPEST KERESZTURI UT 30-38 HUNGARY
Initial Date of Registration : 2022-12-15
Latest Date of Registration :
| Available Reg. Filing : ASMF, BR |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17193
Submission : 2004-02-26
Status : Active
Type : II
Certificate Number : R1-CEP 2004-053 - Rev 01
Issue Date : 2019-04-16
Type : Chemical
Substance Number : 457
Status : Valid
NDC Package Code : 48581-320
Start Marketing Date : 2020-04-15
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR ...
Certificate Number : CEP 2014-364 - Rev 01
Issue Date : 2023-11-27
Type : Chemical
Substance Number : 576
Status : Valid
Certificate Number : R1-CEP 2007-185 - Rev 02
Issue Date : 2016-12-19
Type : Chemical
Substance Number : 1491
Status : Valid
Registrant Name : Servier Korea Co., Ltd.
Registration Date : 2016-03-23
Registration Number : 20160323-130-H-293-45
Manufacturer Name : EGIS PHARMACEUTICALS PRIVATE LIMITED COMPANY(Egis Pharmaceuticals PLC)
Manufacturer Address : Site 1, H-1106 Budapest, X. Kereszturi Ut 30-38
| Available Reg. Filing : CN, BR |
Certificate Number : R1-CEP 2003-042 - Rev 03
Issue Date : 2019-02-20
Type : Chemical
Substance Number : 1745
Status : Valid
Certificate Number : CEP 2023-144 - Rev 00
Issue Date : 2024-12-19
Type : Chemical
Substance Number : 2594
Status : Valid
Egis Pharmaceuticals Plc is a supplier offers 47 products (APIs, Excipients or Intermediates).
Find Promethazine Hydrochloride bulk with DMF, CEP, JDMF offered by Egis Pharmaceuticals Plc
Find Allopurinol bulk with CEP, JDMF offered by Egis Pharmaceuticals Plc
Find Chlorpromazine Hydrochloride bulk with CEP, JDMF offered by Egis Pharmaceuticals Plc
Find Ethacrynic Acid bulk with DMF, CEP offered by Egis Pharmaceuticals Plc
Find Allopurinol bulk with CEP offered by Egis Pharmaceuticals Plc
Find Amlodipine Besylate bulk with CEP offered by Egis Pharmaceuticals Plc
Find Carvedilol bulk with CEP offered by Egis Pharmaceuticals Plc
Find Duloxetine Hydrochloride bulk with CEP offered by Egis Pharmaceuticals Plc
Find Levomepromazine Maleate bulk with CEP offered by Egis Pharmaceuticals Plc
Find Methyldopa bulk with CEP offered by Egis Pharmaceuticals Plc
Find Quetiapine Hemifumarate bulk with CEP offered by Egis Pharmaceuticals Plc
Find Tofisopam bulk with JDMF offered by Egis Pharmaceuticals Plc
Find ABEMACICLIB USP bulk with DMF offered by Egis Pharmaceuticals Plc
Find Abrocitinib bulk offered by Egis Pharmaceuticals Plc
Find Acalabrutinib bulk offered by Egis Pharmaceuticals Plc
Find Avapritinib bulk offered by Egis Pharmaceuticals Plc
Find Bisoprolol Fumarate bulk offered by Egis Pharmaceuticals Plc
Find Blarcamesine bulk offered by Egis Pharmaceuticals Plc
Find Capivasertib bulk offered by Egis Pharmaceuticals Plc
Find Clomiphene Citrate bulk offered by Egis Pharmaceuticals Plc
Find Crotamiton bulk offered by Egis Pharmaceuticals Plc
Find Dabrafenib Mesylate bulk offered by Egis Pharmaceuticals Plc
Find Dapagliflozin Propanediol Monohydrate bulk offered by Egis Pharmaceuticals Plc
Find Darolutamide bulk offered by Egis Pharmaceuticals Plc
Find Deucravacitinib bulk offered by Egis Pharmaceuticals Plc
Find Donepezil bulk offered by Egis Pharmaceuticals Plc
Find Empagliflozin bulk offered by Egis Pharmaceuticals Plc
Find Etrasimod bulk offered by Egis Pharmaceuticals Plc
Find Fezolinetant bulk offered by Egis Pharmaceuticals Plc
Find Ketoprofen bulk offered by Egis Pharmaceuticals Plc
Find LCZ 696 bulk offered by Egis Pharmaceuticals Plc
Find Levocetirizine Dihydrochloride bulk offered by Egis Pharmaceuticals Plc
Find Mavacamten bulk offered by Egis Pharmaceuticals Plc
Find Nifedipine bulk offered by Egis Pharmaceuticals Plc
Find Niraparib Tosylate bulk offered by Egis Pharmaceuticals Plc
Find Nitrendipine bulk offered by Egis Pharmaceuticals Plc
Find Osimertinib Mesylate bulk offered by Egis Pharmaceuticals Plc
Find Ozanimod bulk offered by Egis Pharmaceuticals Plc
Find Ramipril bulk offered by Egis Pharmaceuticals Plc
Find Repotrectinib bulk offered by Egis Pharmaceuticals Plc
Find Resmetirom bulk offered by Egis Pharmaceuticals Plc
Find Ribociclib bulk offered by Egis Pharmaceuticals Plc
Find Rivaroxaban bulk offered by Egis Pharmaceuticals Plc
Find Tofisopam bulk offered by Egis Pharmaceuticals Plc
Find Troriluzole bulk offered by Egis Pharmaceuticals Plc
Find Upadacitinib bulk offered by Egis Pharmaceuticals Plc
Find Zanubrutinib bulk offered by Egis Pharmaceuticals Plc