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Rochem International Inc Rochem International Inc

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

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01 Allopurinol (1)

02 Anastrozole (1)

03 Cabergoline (1)

04 Ciclosporin (1)

05 Entacapone (1)

06 Imatinib mesilate (1)

07 Irbesartan (1)

08 Letrozole (1)

09 Mycophenolate mofetil (1)

10 Mycophenolate mofetil, MYM (1)

11 Olmesartan medoxomil (1)

12 Perindopril tert-butylamine (1)

13 Perindopril tert-butylamine, PER55LP (1)

14 Pramipexole dihydrochloride monohydrate (1)

15 Pravastatin sodium (1)

16 Raloxifene hydrochloride (1)

17 Rizatriptan benzoate (1)

18 Valsartan (1)

19 Voriconazole (1)

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01 APOTEX PHARMACHEM INC. Brantford CA (1)

02 APOTEX PHARMACHEM INDIA PVT. LTD Bangalore IN (11)

03 Apotex Fermentation Inc. Winnipeg CA (1)

04 Apotex Pharmachem Inc. Brantford CA (1)

05 SIGNA S.A. DE C.V. Toluca MX (5)

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01 Canada (13)

02 India (1)

03 Mexico (5)

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01 Expired (6)

02 Valid (10)

03 Withdrawn by Holder (3)

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SIGNA S.A. DE C.V. Tolu...
Valid
R1-CEP 2001-335 - Rev 03
Chemical
2021-03-05
576
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Apotex Pharmachem Inc. ...
Expired
R0-CEP 2014-296 - Rev 00
Chemical
2016-01-15
2021-01-15
2406
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APOTEX PHARMACHEM INDIA...
Valid
CEP 2013-047 - Rev 02
Chemical
2023-11-08
1773
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Apotex Fermentation Inc...
Withdrawn by Holder
R0-CEP 2015-367 - Rev 00
Chemical
2017-11-27
2019-09-24
994
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SIGNA S.A. DE C.V. Tolu...
Expired
R0-CEP 2012-055 - Rev 01
Chemical
2016-08-09
2019-09-12
2574
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SIGNA S.A. DE C.V. Tolu...
Expired
R0-CEP 2015-251 - Rev 03
Chemical
2019-02-14
2021-11-25
2736
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SIGNA S.A. DE C.V. Tolu...
Withdrawn by Holder
R1-CEP 2010-327 - Rev 03
Chemical
2020-01-08
2020-11-02
2465
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APOTEX PHARMACHEM INDIA...
Expired
R0-CEP 2011-066 - Rev 00
Chemical
2013-05-24
2018-05-29
2334
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APOTEX PHARMACHEM INDIA...
Valid
R1-CEP 2010-302 - Rev 01
Chemical
2018-11-20
1700
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APOTEX PHARMACHEM INDIA...
Valid
R1-CEP 2013-263 - Rev 00
Chemical
2019-02-07
1700
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