Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
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52 7Blank
01 2Canada
02 22China
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06 15India
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10 4Netherlands
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12 1South Korea
13 4Spain
14 3Switzerland
15 3U.S.A
16 4United Kingdom
17 9Blank
01 14Active
02 30Inactive
03 33Blank
01 19Valid
02 3Withdrawn by EDQM Failure to CEP procedure
03 8Withdrawn by Holder
04 47Blank
01 1217MF10761
02 1218MF10776
03 1221MF10239
04 1229MF10091
05 1305MF10135
06 1306MF10115
07 71Blank
01 1WC-0010
02 1WC-0023
03 1WC-0121
04 74Blank
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-07
Pay. Date : 2012-12-20
DMF Number : 16950
Submission : 2003-11-14
Status : Active
Type : II
Certificate Number : R1-CEP 2001-367 - Rev 05
Issue Date : 2019-03-21
Type : Chemical
Substance Number : 260
Status : Valid
Registration Number : 305MF10135
Registrant's Address : Bhai Mohan Singh Nagar, Toansa, District SBS Nagar (Nawanshahr), Punjab-144 533, India
Initial Date of Registration : 2023-12-19
Latest Date of Registration : --
Date of Issue : 2022-05-19
Valid Till : 2025-05-27
Written Confirmation Number : WC-0010
Address of the Firm :
NDC Package Code : 70269-100
Start Marketing Date : 2015-11-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ilsung IS Co., Ltd.
Registration Date : 2023-03-30
Registration Number : 20080128-30-A-216-13(6)
Manufacturer Name : Centrient Pharmaceuticals India Private Limited
Manufacturer Address : Bhai Mohan Singh Nagar, Toansa, Distt. Nawanshahr, Punjab 144 533, India
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-16
Pay. Date : 2014-03-05
DMF Number : 25875
Submission : 2012-03-16
Status : Active
Type : II
Certificate Number : R1-CEP 2007-226 - Rev 03
Issue Date : 2019-04-24
Type : Chemical
Substance Number : 260
Status : Valid
NDC Package Code : 70269-100
Start Marketing Date : 2015-11-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ilsung IS Co., Ltd.
Registration Date : 2023-03-30
Registration Number : 20080128-30-A-216-13(6)
Manufacturer Name : Centrient Pharmaceuticals India Private Limited
Manufacturer Address : Bhai Mohan Singh Nagar, Toansa, Distt. Nawanshahr, Punjab 144 533, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32811
Submission : 2018-05-15
Status : Active
Type : II
Certificate Number : CEP 2019-244 - Rev 02
Issue Date : 2023-12-18
Type : Chemical
Substance Number : 260
Status : Valid
NDC Package Code : 55657-101
Start Marketing Date : 2005-08-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2020-07-07
Registration Number : 20200707-30-A-341-24
Manufacturer Name : Sinopharm Weiqida Pharmaceutical Co., Ltd
Manufacturer Address : High-tech Industrial Zone, Economic & Technological Development Zone, Datong, Shanxi, China
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-14
Pay. Date : 2022-03-04
DMF Number : 36579
Submission : 2021-12-23
Status : Active
Type : II
Certificate Number : CEP 2021-461 - Rev 01
Issue Date : 2023-12-20
Type : Chemical
Substance Number : 260
Status : Valid
NDC Package Code : 55657-101
Start Marketing Date : 2005-08-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2020-07-07
Registration Number : 20200707-30-A-341-24
Manufacturer Name : Sinopharm Weiqida Pharmaceutical Co., Ltd
Manufacturer Address : High-tech Industrial Zone, Economic & Technological Development Zone, Datong, Shanxi, China
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-16
Pay. Date : 2022-03-07
DMF Number : 36698
Submission : 2022-02-13
Status : Active
Type : II
NDC Package Code : 55657-101
Start Marketing Date : 2005-08-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2020-07-07
Registration Number : 20200707-30-A-341-24
Manufacturer Name : Sinopharm Weiqida Pharmaceutical Co., Ltd
Manufacturer Address : High-tech Industrial Zone, Economic & Technological Development Zone, Datong, Shanxi, China
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