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01 1Abacavir
02 3Abacavir Sulfate
03 2Abiraterone Acetate
04 1Adenine
05 1Atazanavir
06 3Atazanavir Sulfate
07 2Atovaquone
08 1Bictegravir
09 1Bortezomib
10 1Cabotegravir Sodium
11 1Canagliflozin
12 2Capecitabine
13 1Carboplatin
14 1Dabigatran Etexilate Mesylate
15 3Dasatinib
16 1Dolutegravir Sodium
17 1Dotinurad
18 1Edoxaban Tosylate
19 2Efavirenz
20 1Elafibranor
21 1Elagolix Sodium
22 1Eltrombopag
23 1Elvitegravir
24 2Emtricitabine
25 2Enzalutamide
26 2Erlotinib
27 2Erlotinib Hydrochloride
28 1Finerenone
29 2Gefitinib
30 2Ibrutinib
31 5Imatinib Mesylate
32 1Inclisiran
33 1Irinotecan Hydrochloride
34 1Isavuconazonium Sulfate
35 3Lamivudine
36 1Lasmiditan
37 1Letermovir
38 3Lopinavir
39 2Lumefantrine
40 1Mefloquine
41 1Molnupiravir
42 2Nevirapine
43 1Nilotinib
44 1Nintedanib Esylate
45 1Olaparib
46 1Omadacycline
47 3Oseltamivir Phosphate
48 3Palbociclib
49 2Pazopanib Hydrochloride
50 2Pemetrexed Disodium
51 2Praziquantel
52 1Raltegravir Potassium
53 1Relugolix
54 2Rilpivirine Hydrochloride
55 3Ritonavir
56 1Rosuvastatin Calcium
57 1Sorafenib
58 1Stavudine
59 2Sunitinib
60 1Tedizolid
61 1Tenofovir
62 3Tenofovir Alafenamide Fumarate
63 5Tenofovir Disoproxil Fumarate
64 1Upadacitinib
65 2Zidovudine
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01 55Active
02 6Inactive
03 48Blank
01 15Valid
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01 1221MF10088
02 1222MF10041
03 1231MF10064
04 1305MF10101
05 1306MF10034
06 1307MF10017
07 103Blank
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01 9WC-0327
02 100Blank
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01 120220614-209-J-1315
02 120250418-209-J-1867
03 1Su331-6-ND
04 1Su331-6-ND(A)
05 1Su522-2-ND
06 1Su522-2-ND(A)
07 1Su522-9-ND
08 1Su651-5-ND
09 1Su695-10-ND
10 1Su695-10-ND(A)
11 1Su695-22-ND
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01 142931-089
02 142931-101
03 142931-110
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06 142931-267
07 142931-283
08 142931-320
09 142931-712
10 100Blank
01 109Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-02-23
Pay. Date : 2021-10-29
DMF Number : 36392
Submission : 2021-10-12
Status : Active
Type : II
Registration Number : 305MF10101
Registrant's Address : No. 77D & 116/117, KIADB Industrial Area, Jigani, Phase - 2, Anekal Taluk, Bangalore - 560105, India
Initial Date of Registration : 2023-08-30
Latest Date of Registration :
Date of Issue : 2024-05-20
Valid Till : 2027-07-15
Written Confirmation Number : WC-0327
Address of the Firm :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-06
Pay. Date : 2016-09-09
DMF Number : 25054
Submission : 2011-06-14
Status : Active
Type : II
Registration Number : 231MF10064
Registrant's Address : No. 77D & 116/117, KIADB Industrial Area, Jigani, Bangalore-560 105, Karnataka, INDIA
Initial Date of Registration : 2019-03-05
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2013-309 - Rev 03
Issue Date : 2021-09-08
Type : Chemical
Substance Number : 2762
Status : Valid
Date of Issue : 2024-05-20
Valid Till : 2027-07-15
Written Confirmation Number : WC-0327
Address of the Firm :
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2025-04-18
Registration Number : 20250418-209-J-1867
Manufacturer Name : CDYMAX (India) Pharma Private Limited
Manufacturer Address : No. 116/117, KIADB Industrial Area, 2nd Phase, Anekal Taluk, Jigani, Bengaluru - 560 105, India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-24
Pay. Date : 2021-06-25
DMF Number : 35990
Submission : 2021-06-02
Status : Active
Type : II
Date of Issue : 2024-05-20
Valid Till : 2027-07-15
Written Confirmation Number : WC-0327
Address of the Firm :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41910
Submission : 2025-06-16
Status : Active
Type : II
Registration Number : 307MF10017
Registrant's Address : No. 1479, Zhangjiang Road, Zhangjiang High Tech Park, Shanghai 201203, China
Initial Date of Registration : 2025-01-23
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37904
Submission : 2022-12-22
Status : Active
Type : II
Date of Issue : 2024-05-20
Valid Till : 2027-07-15
Written Confirmation Number : WC-0327
Address of the Firm :
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2025-07-25
Registration Number : Su522-9-ND
Manufacturer Name : Cdymax (India) Pharma Private Limited
Manufacturer Address : 116/117, KIADB Industrial Area Jigani, Bangalore -560105, Karnataka, India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-25
Pay. Date : 2021-06-16
DMF Number : 36007
Submission : 2021-06-04
Status : Active
Type : II
Date of Issue : 2024-05-20
Valid Till : 2027-07-15
Written Confirmation Number : WC-0327
Address of the Firm :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2023-069 - Rev 00
Issue Date : 2024-10-14
Type : Chemical
Substance Number : 2736
Status : Valid
Date of Issue : 2024-05-20
Valid Till : 2027-07-15
Written Confirmation Number : WC-0327
Address of the Firm :
Registrant Name : Toru Co., Ltd.
Registration Date : 2024-11-18
Registration Number : Su651-5-ND
Manufacturer Name : Cdymax (India) Pharma Private Limited
Manufacturer Address : No. 116/117, KIADB Industrial Area, Jigani, 2nd Phase, Bangalore-560 105, Karnataka, India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40658
Submission : 2024-12-30
Status : Active
Type : II
Registration Number : 306MF10034
Registrant's Address : No. 1479, Zhangjiang Road, Zhangjiang High Tech Park, Shanghai 201203, China
Initial Date of Registration : 2024-02-29
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-10-12
Pay. Date : 2018-09-06
DMF Number : 33055
Submission : 2018-08-14
Status : Active
Type : II
Date of Issue : 2024-05-20
Valid Till : 2027-07-15
Written Confirmation Number : WC-0327
Address of the Firm :
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2022-08-08
Registration Number : Su695-10-ND(A)
Manufacturer Name : Cdymax (India) Pharma Private Limited
Manufacturer Address : 116/117, KIADB Industrial Area, Jigani, Phase-2, Anekal Taluk, Bangalore - 560105, India

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