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 1Capital Farma
04 4CKD Bio Corporation
05 1Darou Pakhsh Pharma Chem
06 3Deva Holding AS
07 4Fermic
08 1Fuan Pharmaceutical
09 1GC Chemie Pharmie Ltd
10 4GSK
11 1Hengdian Group
12 7Lek Pharmaceuticals
13 4Lunan Pharmaceutical
14 1Otto Brandes
15 2Sandoz B2B
16 3Sinopharm Weiqida Pharmaceutical Co Ltd
17 4Zhuhai United Laboratories Co ., Ltd.
18 1Blank
01 13China
02 1Germany
03 1India
04 1Iran
05 4Mexico
06 1Netherlands
07 7Slovenia
08 4South Korea
09 1Spain
10 2Switzerland
11 3Turkey
12 1U.S.A
13 4United Kingdom
14 1Blank
01 16Active
02 9Inactive
03 19Blank
01 1Expired
02 29Valid
03 4Withdrawn by Holder
04 10Blank
01 44Blank
01 44Blank
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.
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16427
Submission : 2003-01-21
Status : Active
Type : II
Certificate Number : R1-CEP 2005-180 - Rev 03
Issue Date : 2017-01-18
Type : Chemical and TSE
Substance Number : 1653
Status : Valid
NDC Package Code : 52972-0031
Start Marketing Date : 2003-02-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Chong Kun Dang Bio Co., Ltd.
Registration Date : 2009-01-30
Registration Number : 20090130-113-F-32-06
Manufacturer Name : Chong Kun Dang Bio Co., Ltd._x000D_
Manufacturer Address : (425-100) 292 Sinwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do (368-3, Chungjeong-ro 3-ga, Seodaemun-gu, Seoul (120-756)) 455 Moknae-dong, Danwon-gu, Ansan-si, Gyeonggi-do
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-02
Pay. Date : 2013-06-11
DMF Number : 18362
Submission : 2005-04-14
Status : Active
Type : II
Certificate Number : R1-CEP 2005-178 - Rev 02
Issue Date : 2017-01-20
Type : Chemical and TSE
Substance Number : 1653
Status : Valid
NDC Package Code : 52972-0031
Start Marketing Date : 2003-02-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Chong Kun Dang Bio Co., Ltd.
Registration Date : 2009-01-30
Registration Number : 20090130-113-F-32-06
Manufacturer Name : Chong Kun Dang Bio Co., Ltd._x000D_
Manufacturer Address : (425-100) 292 Sinwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do (368-3, Chungjeong-ro 3-ga, Seodaemun-gu, Seoul (120-756)) 455 Moknae-dong, Danwon-gu, Ansan-si, Gyeonggi-do
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-05
Pay. Date : 2013-09-26
DMF Number : 18363
Submission : 2005-04-14
Status : Active
Type : II
Certificate Number : R1-CEP 2003-183 - Rev 04
Issue Date : 2017-01-26
Type : Chemical and TSE
Substance Number : 1140
Status : Valid
NDC Package Code : 52972-0031
Start Marketing Date : 2003-02-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Chong Kun Dang Bio Co., Ltd.
Registration Date : 2009-01-30
Registration Number : 20090130-113-F-32-06
Manufacturer Name : Chong Kun Dang Bio Co., Ltd._x000D_
Manufacturer Address : (425-100) 292 Sinwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do (368-3, Chungjeong-ro 3-ga, Seodaemun-gu, Seoul (120-756)) 455 Moknae-dong, Danwon-gu, Ansan-si, Gyeonggi-do
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 2011-374 - 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
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 : Reviewed
Rev. Date : 2012-12-26
Pay. Date : 2012-12-03
DMF Number : 16264
Submission : 2002-11-25
Status : Active
Type : II
Certificate Number : CEP 2006-021 - Rev 03
Issue Date : 2024-03-12
Type : Chemical
Substance Number : 1653
Status : Valid
NDC Package Code : 39390-0043
Start Marketing Date : 2018-11-23
End Marketing Date : 2028-01-13
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Inistesti Co., Ltd.
Registration Date : 2018-01-25
Registration Number : 20090617-113-F-45-14(5)
Manufacturer Name : Fermic, SA de. CV
Manufacturer Address : Reforma No. 873 Col. San Nicolas Tolentino Iztapalapa, 09850, Mexico
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-04-23
Pay. Date : 2013-04-10
DMF Number : 16265
Submission : 2002-11-25
Status : Active
Type : II
Certificate Number : R1-CEP 2000-404 - Rev 04
Issue Date : 2022-11-24
Type : Chemical
Substance Number : 1140
Status : Valid
NDC Package Code : 39390-0043
Start Marketing Date : 2018-11-23
End Marketing Date : 2028-01-13
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Inistesti Co., Ltd.
Registration Date : 2018-01-25
Registration Number : 20090617-113-F-45-14(5)
Manufacturer Name : Fermic, SA de. CV
Manufacturer Address : Reforma No. 873 Col. San Nicolas Tolentino Iztapalapa, 09850, Mexico
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 : Reviewed
Rev. Date : 2018-07-13
Pay. Date : 2018-06-21
DMF Number : 14679
Submission : 2000-01-19
Status : Active
Type : II
Certificate Number : CEP 1998-142 - Rev 10
Issue Date : 2024-08-02
Type : Chemical
Substance Number : 1140
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-05-10
Pay. Date : 2015-08-19
DMF Number : 29292
Submission : 2015-08-20
Status : Active
Type : II
Certificate Number : R0-CEP 2004-234 - Rev 01
Issue Date : 2009-10-13
Type : Chemical
Substance Number : 1653
Status : Expired
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 : 2023-03-07
Pay. Date : 2023-02-02
DMF Number : 36941
Submission : 2023-01-17
Status : Active
Type : II
Certificate Number : R1-CEP 2004-242 - 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 : 2023-12-07
Pay. Date : 2022-11-23
DMF Number : 37008
Submission : 2023-09-27
Status : Active
Type : II
Certificate Number : R1-CEP 2007-258 - Rev 02
Issue Date : 2021-03-05
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 14065
Submission : 1999-04-07
Status : Inactive
Type : II
Certificate Number : R1-CEP 1998-129 - Rev 08
Issue Date : 2017-10-18
Type : Chemical
Substance Number : 1140
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4349
Submission : 1981-12-02
Status : Inactive
Type : II
Certificate Number : R1-CEP 1999-113 - Rev 04
Issue Date : 2014-02-26
Type : Chemical
Substance Number : 1140
Status : Valid
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2020-03-10
Registration Number : 20200310-113-F-91-24
Manufacturer Name : SmithKline Beecham Pharmaceuticals
Manufacturer Address : Shewalton Road, Irvine, KA11 5AP United Kingdom
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5701
Submission : 1985-02-13
Status : Inactive
Type : II
Certificate Number : R1-CEP 2005-244 - Rev 01
Issue Date : 2017-12-01
Type : Chemical
Substance Number : 1653
Status : Valid
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2020-03-10
Registration Number : 20200310-113-F-91-24
Manufacturer Name : SmithKline Beecham Pharmaceuticals
Manufacturer Address : Shewalton Road, Irvine, KA11 5AP United Kingdom
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7048
Submission : 1987-07-09
Status : Inactive
Type : II
Certificate Number : R0-CEP 2006-068 - Rev 01
Issue Date : 2010-02-02
Type : Chemical
Substance Number : 1653
Status : Withdrawn by Holder
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2020-03-10
Registration Number : 20200310-113-F-91-24
Manufacturer Name : SmithKline Beecham Pharmaceuticals
Manufacturer Address : Shewalton Road, Irvine, KA11 5AP United Kingdom
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16005
Submission : 2002-06-13
Status : Inactive
Type : II
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2020-03-10
Registration Number : 20200310-113-F-91-24
Manufacturer Name : SmithKline Beecham Pharmaceuticals
Manufacturer Address : Shewalton Road, Irvine, KA11 5AP United Kingdom
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26111
Submission : 2012-05-29
Status : Inactive
Type : II
Certificate Number : CEP 2013-133 - Rev 02
Issue Date : 2024-03-04
Type : Chemical
Substance Number : 1140
Status : Valid
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2017-06-28
Registration Number : 20101130-113-F-56-15(7)
Manufacturer Name : Zhuhai United Laboratories Co., Ltd.
Manufacturer Address : No.2428, Anji Road, Sanzao Town, Jinwan District, Zhuhai, Guangdong 519040, PRChina
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28638
Submission : 2014-09-15
Status : Inactive
Type : II
Certificate Number : R1-CEP 2015-083 - Rev 00
Issue Date : 2021-11-26
Type : Chemical
Substance Number : 1140
Status : Valid
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2017-06-28
Registration Number : 20101130-113-F-56-15(7)
Manufacturer Name : Zhuhai United Laboratories Co., Ltd.
Manufacturer Address : No.2428, Anji Road, Sanzao Town, Jinwan District, Zhuhai, Guangdong 519040, PRChina
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19677
Submission : 2006-06-16
Status : Inactive
Type : II
Certificate Number : R1-CEP 2011-376 - 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 : 14436
Submission : 1999-10-05
Status : Inactive
Type : II
Certificate Number : R1-CEP 2009-358 - Rev 00
Issue Date : 2015-02-17
Type : Chemical
Substance Number : 1653
Status : Valid
NDC Package Code : 39390-0043
Start Marketing Date : 2018-11-23
End Marketing Date : 2028-01-13
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Inistesti Co., Ltd.
Registration Date : 2018-01-25
Registration Number : 20090617-113-F-45-14(5)
Manufacturer Name : Fermic, SA de. CV
Manufacturer Address : Reforma No. 873 Col. San Nicolas Tolentino Iztapalapa, 09850, Mexico
Certificate Number : R1-CEP 2007-259 - Rev 02
Issue Date : 2021-03-05
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
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 1999-111 - Rev 04
Issue Date : 2024-11-13
Type : Chemical
Substance Number : 1140
Status : Valid
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A Clavulanate Potassium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clavulanate Potassium, including repackagers and relabelers. The FDA regulates Clavulanate Potassium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clavulanate Potassium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Clavulanate Potassium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Clavulanate Potassium supplier is an individual or a company that provides Clavulanate Potassium active pharmaceutical ingredient (API) or Clavulanate Potassium finished formulations upon request. The Clavulanate Potassium suppliers may include Clavulanate Potassium API manufacturers, exporters, distributors and traders.
click here to find a list of Clavulanate Potassium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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