01 8ACS DOBFAR SPA
02 1Ajanta Pharma Limited
03 2Aurobindo Pharma Limited
04 1Bristol Myers Squibb
05 3Centrient Pharmaceuticals
06 1China Union Chempharma (Suzhou) Co.,Ltd
07 1CordenPharma
08 1Grand Health Industrial Co Ltd
09 1Hikma Pharmaceuticals
10 4Lupin Ltd
11 1Orchid Pharma
12 2Orchidia Pharmaceutical Ind.
13 1Qilu Pharmaceutical
14 1Sneha Medicare Pvt Ltd
15 2Sun Pharmaceutical Industries Limited
16 3Blank
01 3China
02 2Egypt
03 1Germany
04 11India
05 8Italy
06 3Netherlands
07 1U.S.A
08 1United Kingdom
09 3Blank
01 5Active
02 10Inactive
03 18Blank
01 3Valid
02 2Withdrawn by Holder
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01 33Blank
01 1WC-0023
02 2WC-0048
03 1WC-0120
04 29Blank
01 120050831-19-A-11-02
02 120050831-19-A-11-02(2)
03 120050831-19-A-11-02(3)
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05 120050831-19-A-11-02(6)
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07 120050831-19-A-11-02(8)
08 120050831-19-A-11-02(9)
09 120050831-19-A-15-05
10 120050831-19-A-15-05(2)
11 120050831-19-A-15-05(3)
12 120050831-19-A-8-01
13 120050831-19-A-8-01(1)
14 120120106-19-A-256-09
15 120120106-19-A-256-09(1)
16 120120106-19-A-256-09(2)
17 120120106-19-A-256-09(3)
18 120180516-19-A-340-10
19 15Blank
01 152946-0903
02 161303-111
03 161303-715
04 165862-359
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GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-22
Pay. Date : 2013-01-11
DMF Number : 13749
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : CEP 2002-156 - Rev 06
Issue Date : 2024-08-22
Type : Chemical
Substance Number : 813
Status : Valid
NDC Package Code : 61303-111
Start Marketing Date : 2007-06-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Daewoong Bio Co., Ltd.
Registration Date : 2019-04-04
Registration Number : 20050831-19-A-15-05(3)
Manufacturer Name : Centrient Pharmaceuticals Spain S.A.
Manufacturer Address : C/Ripolles, n2 Poligono Industrial URVASA Santa Perpetua de Mogoda 08130 BARCELONA SPAIN (POBox 425, 2600 AK Delft, The Netherlands)
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17106
Submission : 2004-01-14
Status : Active
Type : II
Certificate Number : CEP 2002-234 - Rev 03
Issue Date : 2024-09-06
Type : Chemical
Substance Number : 813
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19290
Submission : 2006-03-21
Status : Active
Type : II
Date of Issue : 2025-07-07
Valid Till : 2028-07-31
Written Confirmation Number : WC-0048
Address of the Firm :
Registrant Name : Pampia Co., Ltd.
Registration Date : 2024-07-30
Registration Number : 20120106-19-A-256-09(3)
Manufacturer Name : Lupin Limited
Manufacturer Address : Plot No. 9,123,123/1, 124&125 GIDC Estate, Ankleshwar, 393 002, Bharuch Gujarat state, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18331
Submission : 2005-04-30
Status : Active
Type : II
Certificate Number : CEP 2006-203 - Rev 03
Issue Date : 2023-12-13
Type : Chemical
Substance Number : 813
Status : Withdrawn by Holder
Date of Issue : 2025-07-11
Valid Till : 2028-07-02
Written Confirmation Number : WC-0120
Address of the Firm :
NDC Package Code : 65862-359
Start Marketing Date : 2024-01-11
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2018-05-16
Registration Number : 20180516-19-A-340-10
Manufacturer Name : Aurobindo Pharma Limited (Unit-XI)
Manufacturer Address : Sy.Nos.1/22, 2/1 to 5, 6 to 18, 61 to 69, Pydibhimavaram Village, Ranasthalam Mandal, Srikakulam Dist., Andhra Pradesh, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12894
Submission : 1998-03-11
Status : Inactive
Type : II
Certificate Number : R1-CEP 1998-019 - Rev 00
Issue Date : 2003-12-18
Type : Chemical
Substance Number : 813
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13761
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13566
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14201
Submission : 1999-06-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13220
Submission : 1998-04-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13638
Submission : 1998-09-01
Status : Inactive
Type : II
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A Duracef manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Duracef, including repackagers and relabelers. The FDA regulates Duracef manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Duracef 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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A Duracef supplier is an individual or a company that provides Duracef active pharmaceutical ingredient (API) or Duracef finished formulations upon request. The Duracef suppliers may include Duracef API manufacturers, exporters, distributors and traders.
click here to find a list of Duracef suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
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