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01 1Jai Radhe Sales
02 1LGM Pharma
03 1Emay Pharmaceuticals
04 1IOL Chemicals and Pharmaceuticals
05 1Pharm-RX Chemical
06 1HRV Global Life Sciences
07 1Zeon Pharma Industries India Pvt Ltd
08 1Alkem Laboratories
09 1Arene Lifesciences
10 1Beloorbayir Biotech
11 1Dishman Carbogen Amcis
12 1Flamma SpA
13 1Fujian South Pharmaceutical
14 1Global Calcium
15 1Gokulendu Life Science
16 1Guangzhou Tosun Pharmaceutical
17 1Hebi Xinhe Pharmaceutical
18 1Hermes Chemical
19 1Icrom
20 2Kumar Organic Products
21 1Olon S.p.A
22 1Pfizer Inc
23 1Remedy Labs
24 1Sms Lifesciences
25 1Trifarma
26 1VPL Chemicals
27 1Xian Tian Guangyuan Biotech
28 2Blank
01 4China
02 17India
03 4Italy
04 3U.S.A
05 2Blank
01 6Active
02 2Inactive
03 22Blank
01 6Valid
02 1Withdrawn by Holder
03 23Blank
01 30Blank
01 1WC-0104
02 1WC-0238
03 1WC-0238A3
04 1WC-0388
05 26Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-04
Pay. Date : 2021-02-24
DMF Number : 22367
Submission : 2009-01-02
Status : Active
Type : II
Certificate Number : CEP 2013-310 - Rev 02
Issue Date : 2024-08-20
Type : Chemical
Substance Number : 937
Status : Valid
Date of Issue : 2021-02-12
Valid Till : 2024-01-28
Written Confirmation Number : WC-0238
Address of the Firm :
NDC Package Code : 63934-007
Start Marketing Date : 2004-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34939
Submission : 2020-08-27
Status : Active
Type : II
Certificate Number : R0-CEP 2021-075 - Rev 00
Issue Date : 2023-03-27
Type : Chemical
Substance Number : 937
Status : Valid
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0104
Address of the Firm :
NDC Package Code : 64162-0210
Start Marketing Date : 2023-05-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-09-05
Pay. Date : 2014-08-04
DMF Number : 5977
Submission : 1985-08-19
Status : Active
Type : II
NDC Package Code : 46204-0159
Start Marketing Date : 2017-12-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Daeshin Pharmaceutical Co., Ltd.
Registration Date : 2022-11-10
Registration Number : 20210406-211-J-742(1)
Manufacturer Name : Trifarma SpA
Manufacturer Address : Via delle Industrie 6 - 20816 Ceriano Laghetto (MB) - ITALY
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