LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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01 1LGM Pharma
02 1HRV Global Life Sciences
03 1Bioquim
04 2ACS DOBFAR SPA
05 1ADL BioPharma
06 1Asia Pioneer Pharmaceuticals
07 2Aurobindo Pharma Limited
08 1Bayer AG
09 1Bristol Myers Squibb
10 1CSPC Pharmaceutical Group
11 1Eumedica Pharmaceuticals
12 2Fresenius Kabi AB Brunna
13 1Fresenius Kabi AG
14 1Fresenius Kabi Anti-Infectives
15 1GSK
16 1Istituto Biochimico Italiano Giovanni Lorenzini SpA
17 1Kaliberr Labs
18 1Meiji Seika Pharma
19 1Mustafa Nevzat Ilac Sanayi A S
20 1North China Pharmaceutical Co., Ltd.
21 1Pfizer Inc
22 1Qingdao Qingmei Biotech
23 1Reyoung pharmaceutical
24 2Sandoz B2B
25 1Shandong Lukang Pharmaceutical Co., Ltd
26 1Sichuan Renan Pharmaceutical
27 1Sterile India Pvt. Ltd
28 1Tecoland Corporation
29 1Vaishali Pharma Ltd
30 1Wyeth Pharmaceuticals Inc
31 1Zhuhai United Laboratories Co ., Ltd.
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01 7China
02 2Germany
03 6India
04 4Italy
05 1Japan
06 2Spain
07 2Sweden
08 3Switzerland
09 1Turkey
10 6U.S.A
11 1United Kingdom
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01 9Active
02 6Inactive
03 20Blank
01 6Valid
02 1Withdrawn by Holder
03 28Blank
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01 1217MF10454
02 1217MF11156
03 1219MF10051
04 1226MF10211
05 1230MF10039
06 1301MF10053
07 1302MF10023
08 1302MF10114
09 1306MF10137
10 26Blank
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01 1WC-0121
02 1WC-0378
03 33Blank
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01 120200603-210-J-404
02 120200603-210-J-404(1)
03 120200813-210-J-589
04 120201104-210-J-578
05 120201104-210-J-578(1)
06 120230512-210-J-1491
07 120250220-210-J-1518
08 28Blank
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01 152946-0705
02 152946-0901
03 165862-282
04 165862-283
05 166558-0080
06 166558-0201
07 184344-002
08 28Blank
01 35Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-04-20
Pay. Date : 2023-04-17
DMF Number : 13754
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : CEP 1993-005 - Rev 08
Issue Date : 2024-02-20
Type : Chemical
Substance Number : 578
Status : Valid
Registration Number : 217MF10454
Registrant's Address : Biochemiesstrasse 10,6250 Kundl, Austria
Initial Date of Registration : 2005-08-24
Latest Date of Registration :
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2021-11-05
Registration Number : 20200603-210-J-404(1)
Manufacturer Name : Sandoz GmbH@Sandoz Industrial Products S.A.
Manufacturer Address : Biochemiestraβe 10 6250 Kundl Austria@Ctra. Granollers - Cardedeu C-251, km 4 08520 LES FRANQUESES DEL VALLES BARCELONA Spain
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13742
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : CEP 1999-169 - Rev 07
Issue Date : 2024-02-27
Type : Chemical
Substance Number : 578
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29984
Submission : 2018-05-04
Status : Active
Type : II
Date of Issue : 2022-08-12
Valid Till : 2025-07-06
Written Confirmation Number : WC-0378
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13425
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24360
Submission : 2010-11-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13532
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13379
Submission : 1998-09-01
Status : Inactive
Type : II
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A Binotal sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Binotal sodium, including repackagers and relabelers. The FDA regulates Binotal sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Binotal sodium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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We have 31 companies offering Binotal sodium
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