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KEY PRODUCTS
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01 1Acotiamide
02 1Apremilast
03 1Dantrolene Sodium
04 1Daprodustat
05 1Delafloxacin
06 1Dotinurad
07 1Ebastine
08 1Elagolix Sodium
09 1Etrasimod
10 1Finerenone
11 1Flupirtine
12 1Iguratimod
13 1Ivabradine Hydrochloride
14 1Leflunomide
15 1Levodropropizine
16 1Levonadifloxacin
17 1Mirabegron
18 1Nadifloxacin
19 1Obicetrapib
20 1Omadacycline
21 1Orbifloxacin
22 1Oxeladin
23 1Pidotimod
24 1Relugolix
25 1Resmetirom
26 2Rosuvastatin Calcium
27 1Silodosin
28 1Ticagrelor
29 1Tigecycline
30 1Tofacitinib Citrate
31 1Tribenoside
32 1Triclofos Sodium
33 1Vibegron
34 1Vigabatrin
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01 1Active
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01 2Valid
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01 35Blank
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01 3WC-0569
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01 120250113-209-J-1738
02 120250113-209-J-1738(1)
03 1Su1004-6-ND
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39043
Submission : 2024-06-05
Status : Active
Type : II
Certificate Number : CEP 2022-473 - Rev 00
Issue Date : 2024-07-24
Type : Chemical
Substance Number : 2631
Status : Valid
Date of Issue : 2023-09-18
Valid Till : 2026-09-17
Written Confirmation Number : WC-0569
Address of the Firm :
Registrant Name : Hanyoung Pharm Co., Ltd.
Registration Date : 2025-03-07
Registration Number : 20250113-209-J-1738(1)
Manufacturer Name : LEWENS LABS PVT. LTD.
Manufacturer Address : PLOT NO. - D – 2 / CH 376 / 377, GIDC, CITY - DAHEJ, DIST. BHARUCH, GUJARAT STATE, INDIA
Date of Issue : 2023-09-18
Valid Till : 2026-09-17
Written Confirmation Number : WC-0569
Address of the Firm :
Certificate Number : CEP 2024-344 - Rev 00
Issue Date : 2025-07-25
Type : Chemical
Substance Number : 3132
Status : Valid
Registrant Name : Huseong Bio Co., Ltd.
Registration Date : 2026-04-17
Registration Number : Su1004-6-ND
Manufacturer Name : LEWENS LABS PVT. LTD.
Manufacturer Address : Plot No. D-2/CH 376 / 377, GIDC, City – Dahej, Dist.- Bharuch, Gujarat State, India
Date of Issue : 2023-09-18
Valid Till : 2026-09-17
Written Confirmation Number : WC-0569
Address of the Firm :
Lewens Labs is a supplier offers 35 products (APIs, Excipients or Intermediates).
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