Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.

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01 1Bioquim
02 1LGM Pharma
03 1HRV Pharma
04 2ACS DOBFAR SPA
05 1ADL BioPharma
06 1Asia Pioneer Pharmaceuticals
07 2Aurobindo Pharma Limited
08 1Bristol Myers Squibb
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13 2Fresenius Kabi AB Brunna
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15 1Fresenius Kabi Anti-Infectives
16 1GSK
17 1Istituto Biochimico Italiano Giovanni Lorenzini SpA
18 1Kaliberr Labs
19 1Meiji Seika Pharma
20 1Mustafa Nevzat Ilac Sanayi A S
21 1North China Pharmaceutical Co., Ltd.
22 1Pfizer Inc
23 1Qingdao Qingmei Biotech
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25 1Reyoung pharmaceutical
26 2Sandoz B2B
27 1Shandong Lukang Pharmaceutical Co., Ltd
28 1Sichuan Renan Pharmaceutical
29 1Sterile India Pvt. Ltd
30 1Vaishali Pharma Ltd
31 1Wyeth Pharmaceuticals Inc
32 1Zhuhai United Laboratories Co ., Ltd.
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01 7China
02 1Germany
03 1Hungary
04 8India
05 4Italy
06 1Japan
07 2Spain
08 2Sweden
09 3Switzerland
10 1Turkey
11 5U.S.A
12 1United Kingdom
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01 9Active
02 5Inactive
03 22Blank
01 6Valid
02 2Withdrawn 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 1307MF10064
11 1307MF10065
12 25Blank
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01 1WC-0121
02 1WC-0378
03 1WC-0420
04 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 29Blank
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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 29Blank
01 36Blank
Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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 : Withdrawn by Holder

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 2024-480 - Rev 01
Issue Date : 2025-12-16
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 : 29984
Submission : 2018-05-04
Status : Active
Type : II
Date of Issue : 2025-09-24
Valid Till : 2028-07-06
Written Confirmation Number : WC-0378
Address of the Firm :

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

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

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A Ampiplus Simplex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ampiplus Simplex, including repackagers and relabelers. The FDA regulates Ampiplus Simplex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ampiplus Simplex 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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