Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
01 1Centrient Pharmaceuticals
02 1Rochem International Inc
03 4CKD Bio Corporation
04 1Darou Pakhsh Pharma Chem
05 3Deva Holding AS
06 4Fermic
07 1Fuan Pharmaceutical
08 1GC Chemie Pharmie Ltd
09 4GSK
10 1Hengdian Group
11 7Lek Pharmaceuticals
12 4Lunan Pharmaceutical
13 1Otto Brandes
14 2Sandoz B2B
15 3Sinopharm Weiqida Pharmaceutical Co Ltd
16 4Zhuhai United Laboratories Co ., Ltd.
01 13China
02 1Germany
03 1India
04 1Iran
05 4Mexico
06 1Netherlands
07 7Slovenia
08 4South Korea
09 2Switzerland
10 3Turkey
11 1U.S.A
12 4United Kingdom
01 16Active
02 9Inactive
03 17Blank
01 1Expired
02 29Valid
03 4Withdrawn by Holder
04 8Blank
01 42Blank
01 42Blank
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-29
Pay. Date : 2014-02-13
DMF Number : 25714
Submission : 2012-01-16
Status : Active
Type : II
Certificate Number : R1-CEP 2011-376 - Rev 02
Issue Date : 2021-03-01
Type : Chemical
Substance Number : 1653
Status : Valid
NDC Package Code : 42677-104
Start Marketing Date : 2007-02-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (0.5kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2018-01-16
Registration Number : 20120615-113-F-69-16(1)
Manufacturer Name : Shandong New Time Pharmaceutical Co.,Ltd.
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25718
Submission : 2012-01-16
Status : Active
Type : II
Certificate Number : R1-CEP 2011-375 - Rev 02
Issue Date : 2021-04-08
Type : Chemical
Substance Number : 1653
Status : Valid
NDC Package Code : 42677-104
Start Marketing Date : 2007-02-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (0.5kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2018-01-16
Registration Number : 20120615-113-F-69-16(1)
Manufacturer Name : Shandong New Time Pharmaceutical Co.,Ltd.
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-09-13
Pay. Date : 2014-02-13
DMF Number : 25719
Submission : 2012-01-16
Status : Active
Type : II
NDC Package Code : 42677-104
Start Marketing Date : 2007-02-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (0.5kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2018-01-16
Registration Number : 20120615-113-F-69-16(1)
Manufacturer Name : Shandong New Time Pharmaceutical Co.,Ltd.
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15211
Submission : 2000-12-26
Status : Active
Type : II
Certificate Number : R1-CEP 2003-262 - Rev 03
Issue Date : 2020-06-17
Type : Chemical
Substance Number : 1140
Status : Valid
NDC Package Code : 48866-9981
Start Marketing Date : 2022-11-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (20kg/20kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2022-04-25
Registration Number : 20220425-113-F-96-26
Manufacturer Name : Lek farmacevtska družba dd, Poslovna enota Proizvodnja Lendava
Manufacturer Address : Trimlini 2D, Lendava, 9220, Slovenia
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-10-24
Pay. Date : 2018-05-17
DMF Number : 32777
Submission : 2018-05-17
Status : Active
Type : II
Certificate Number : R1-CEP 2004-241 - Rev 03
Issue Date : 2020-02-07
Type : Chemical
Substance Number : 1653
Status : Valid
NDC Package Code : 48866-9981
Start Marketing Date : 2022-11-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (20kg/20kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2022-04-25
Registration Number : 20220425-113-F-96-26
Manufacturer Name : Lek farmacevtska družba dd, Poslovna enota Proizvodnja Lendava
Manufacturer Address : Trimlini 2D, Lendava, 9220, Slovenia
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-06
Pay. Date : 2014-03-31
DMF Number : 27903
Submission : 2014-02-05
Status : Active
Type : II
Certificate Number : R1-CEP 2014-329 - Rev 00
Issue Date : 2021-03-03
Type : Chemical
Substance Number : 1653
Status : Valid
NDC Package Code : 55657-105
Start Marketing Date : 2006-02-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/2kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2014-10-10
Registration Number : 20141010-113-F-78-23
Manufacturer Name : Sinopharm Weiqida Pharmaceutical Co., Ltd.
Manufacturer Address : Pharmaceutical Industrial Park, Economic & Technological Development Zone, Datong, Shanxi, China
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-09-08
Pay. Date : 2014-03-31
DMF Number : 27966
Submission : 2014-03-12
Status : Active
Type : II
Certificate Number : R1-CEP 2014-320 - Rev 00
Issue Date : 2021-03-05
Type : Chemical
Substance Number : 1140
Status : Valid
NDC Package Code : 55657-105
Start Marketing Date : 2006-02-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/2kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2014-10-10
Registration Number : 20141010-113-F-78-23
Manufacturer Name : Sinopharm Weiqida Pharmaceutical Co., Ltd.
Manufacturer Address : Pharmaceutical Industrial Park, Economic & Technological Development Zone, Datong, Shanxi, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19677
Submission : 2006-06-16
Status : Inactive
Type : II
Certificate Number : R1-CEP 2011-374 - Rev 00
Issue Date : 2017-12-15
Type : Chemical
Substance Number : 1140
Status : Valid
NDC Package Code : 42677-104
Start Marketing Date : 2007-02-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (0.5kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2018-01-16
Registration Number : 20120615-113-F-69-16(1)
Manufacturer Name : Shandong New Time Pharmaceutical Co.,Ltd.
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China
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