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01 1Abacavir
02 3Abacavir Sulfate
03 2Abiraterone Acetate
04 1Adenine
05 1Atazanavir
06 3Atazanavir Sulfate
07 1Atovaquone
08 1Bictegravir
09 1Bortezomib
10 1Cabotegravir Sodium
11 1Canagliflozin
12 2Capecitabine
13 1Carboplatin
14 1Dabigatran Etexilate Mesylate
15 3Dasatinib
16 1Dolutegravir Sodium
17 1Edoxaban Tosylate
18 2Efavirenz
19 1Elafibranor
20 1Elagolix Sodium
21 1Eltrombopag
22 1Elvitegravir
23 2Emtricitabine
24 2Enzalutamide
25 2Erlotinib
26 2Erlotinib Hydrochloride
27 2Gefitinib
28 2Ibrutinib
29 5Imatinib Mesylate
30 1Inclisiran
31 1Irinotecan Hydrochloride
32 1Isavuconazonium Sulfate
33 3Lamivudine
34 1Lasmiditan
35 1Letermovir
36 3Lopinavir
37 2Lumefantrine
38 1Mefloquine
39 1Molnupiravir
40 2Nevirapine
41 1Nilotinib
42 1Nintedanib Esylate
43 1Olaparib
44 3Oseltamivir Phosphate
45 3Palbociclib
46 2Pazopanib Hydrochloride
47 2Pemetrexed Disodium
48 2Praziquantel
49 1Raltegravir Potassium
50 1Relugolix
51 2Rilpivirine Hydrochloride
52 3Ritonavir
53 1Rosuvastatin Calcium
54 1Sorafenib
55 1Stavudine
56 2Sunitinib
57 1Tedizolid
58 1Tenofovir
59 3Tenofovir Alafenamide Fumarate
60 5Tenofovir Disoproxil Fumarate
61 2Zidovudine
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02 5Inactive
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01 15Valid
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01 1221MF10088
02 1222MF10041
03 1231MF10064
04 1305MF10101
05 1306MF10034
06 1307MF10017
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01 9WC-0327
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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
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01 142931-089
02 142931-101
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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, Zhangheng Road, Zhengjiang 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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