Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

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01 1Centrient Pharmaceuticals
02 1HRV Pharma
03 3ACS DOBFAR SPA
04 1Akums Lifesciences
05 1Asia Pioneer Pharmaceuticals
06 1Aurobindo Pharma Limited
07 1China Union Chempharma (Suzhou) Co.,Ltd
08 1Covalent Laboratories Private Limited
09 1Freemen Nutra
10 1Guangzhou Baiyunshan Chem.Pharm.Factory
11 1Guangzhou Tosun Pharmaceutical
12 1Hengdian Group
13 1Hetero Drugs
14 1Lupin Ltd
15 1Nishchem International Pvt. Ltd
16 2Orchid Pharma
17 4Qilu Antibiotics Pharmaceutical Co., Ltd.
18 1Qilu Pharmaceutical
19 1Sandoz B2B
20 1Sun Pharmaceutical Industries Limited
21 1Virchow Group
22 1Zhejiang Dongying Pharmaceutical
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01 11China
02 11India
03 3Italy
04 1Netherlands
05 1Switzerland
06 1U.S.A
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01 6Active
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01 5Valid
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01 29Blank
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01 1WC-0120
02 1WC-0202
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01 120180903-209-J-8
02 120180903-209-J-8(2)
03 120180903-209-J-8(3)
04 120180903-209-J-8(4)
05 120181101-209-J-49
06 120181101-209-J-49(1)
07 120181101-209-J-49(2)
08 120201125-209-J-791
09 120210323-209-J-707
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01 157297-400
02 161788-4000
03 165862-378
04 182608-009
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Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17375
Submission : 2004-05-13
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17731
Submission : 2004-09-29
Status : Active
Type : II
Date of Issue : 2025-10-08
Valid Till : 2028-07-04
Written Confirmation Number : WC-0202
Address of the Firm :
NDC Package Code : 57297-400
Start Marketing Date : 2016-02-25
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24047
Submission : 2010-08-06
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2015-07-10
Pay. Date : 2012-12-19
DMF Number : 26699
Submission : 2013-01-09
Status : Active
Type : II
Certificate Number : R0-CEP 2020-252 - Rev 00
Issue Date : 2021-02-19
Type : Chemical
Substance Number : 2342
Status : Valid
Registrant Name : Withers Pharmaceutical Co., Ltd.
Registration Date : 2025-08-25
Registration Number : 20180903-209-J-8(4)
Manufacturer Name : Qilu Antibiotics Pharmaceutical Co., Ltd.
Manufacturer Address : No.849 Dongjia Town, Licheng District, Jinan, Shandong Province, China

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17453
Submission : 2004-06-07
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16973
Submission : 2003-11-21
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18434
Submission : 2005-06-16
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18901
Submission : 2005-10-24
Status : Inactive
Type : II

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