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List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Acs Dobfar Spa by EDQM. Original Data: EDQM Database

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01 Amoxicillin sodium, Sterile (1)

02 Ampicillin sodium, Sterile and bacterial endotoxins free (1)

03 Cefaclor (1)

04 Cefadroxil monohydrate, Powder, compacted (1)

05 Cefalexin monohydrate (1)

06 Cefalexin monohydrate, (Enzymatic process) (1)

07 Cefazolin sodium, Sterile (1)

08 Cefepime dihydrochloride monohydrate, Sterile (1)

09 Cefotaxime sodium, Sterile (1)

10 Ceftazidime pentahydrate with sodium carbonate for injection, Sterile (1)

11 Ceftriaxone sodium, Sterile (1)

12 Ceftriaxone sodium, sterile and bacterial endotoxins free (1)

13 Cefuroxime sodium, Sterile (1)

14 Clindamycin hydrochloride (1)

15 Clindamycin phosphate (1)

16 Clindamycin phosphate, Albano plant (1)

17 Flucloxacillin sodium monohydrate, sterile (1)

18 Meropenem trihydrate, Sterile, synthetic origin, for parenteral preparations (1)

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01 ACS DOBFAR S.P.A. Tribiano IT (17)

02 ANTIBIOTICOS DO BRASIL LTDA. Cosmopolis BR (1)

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01 Brazil (1)

02 Italy (17)

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01 Valid (16)

02 Withdrawn by Holder (2)

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ACS DOBFAR S.P.A. Tribi...
Valid
R1-CEP 1998-069 - Rev 01
Chemical
2009-06-17
577
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ACS DOBFAR S.P.A. Tribi...
Valid
CEP 2004-303 - Rev 03
Chemical
2024-01-24
578
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ACS DOBFAR S.P.A. Tribi...
Valid
R1-CEP 1996-008 - Rev 04
Chemical
2020-12-17
986
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ACS DOBFAR S.P.A. Tribi...
Valid
R1-CEP 1999-174 - Rev 04
Chemical
2023-06-14
813
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ACS DOBFAR S.P.A. Tribi...
Valid
CEP 1996-099 - Rev 04
Chemical
2023-12-06
708
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ACS DOBFAR S.P.A. Tribi...
Valid
R1-CEP 1997-128 - Rev 03
Chemical
2019-08-16
708
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ACS DOBFAR S.P.A. Tribi...
Valid
R1-CEP 1996-083 - Rev 06
Chemical
2019-06-17
988
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ACS DOBFAR S.P.A. Tribi...
Valid
R0-CEP 2023-021 - Rev 00
Chemical
2023-07-27
2126
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ACS DOBFAR S.P.A. Tribi...
Valid
R1-CEP 1998-050 - Rev 03
Chemical
2008-02-28
989
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ANTIBIOTICOS DO BRASIL ...
Valid
R1-CEP 2010-026 - Rev 02
Chemical
2022-10-12
2344
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