Certificates of Suitability (CEP/CEPs/COS)
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Product:
Fluconazole
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Type:
Chemical
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Substance Number:
2287
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Substance:
POLYDRUG LABORATORIES PVT. LTD. Mumbai IN
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Status:
Withdrawn by EDQM Failure to CEP procedure
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Issue Date:
2014-01-21
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Country:
India
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Certificate Number:
R0-CEP 2010-247 - Rev 00
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End Date:
2016-10-26
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Product:
Magnesium sulfate heptahydrate
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Type:
Chemical
-
Substance Number:
44
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Substance:
PQ CORPORATION Malvern US
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Status:
Expired
-
Issue Date:
2020-06-17
-
Country:
United States
-
Certificate Number:
R0-CEP 2018-109 - Rev 00
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End Date:
2025-07-15
PRAVEEN LABORATORIES PRIVATE LIMITED Jolwa Village IN
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Product:
Clopidogrel hydrogen sulfate, Process B
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Type:
Chemical
-
Substance Number:
2531
-
Substance:
PRAVEEN LABORATORIES PRIVATE LIMITED Jolwa Village IN
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Status:
Valid
-
Issue Date:
2026-05-07
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Country:
India
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Certificate Number:
CEP 2017-247 - Rev 02
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End Date:
-
Product:
Clopidogrel hydrogen sulfate, Form-I
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Type:
Chemical
-
Substance Number:
2531
-
Substance:
PRAVEEN LABORATORIES PRIVATE LIMITED Surat IN
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Status:
Valid
-
Issue Date:
2026-05-07
-
Country:
India
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Certificate Number:
CEP 2014-176 - Rev 03
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End Date:
PRECISE BIOPHARMA PRIVATE LIMITED Mumbai IN
-
Product:
Naphazoline nitrate
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Type:
Chemical
-
Substance Number:
147
-
Substance:
PRECISE BIOPHARMA PRIVATE LIMITED Mumbai IN
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Status:
Valid
-
Issue Date:
2026-09-09
-
Country:
India
-
Certificate Number:
CEP 2024-544 - Rev 00
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End Date:
-
Product:
Sheep polyclonal antibodies against human lipoprotein (a)
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Type:
TSE
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Substance Number:
-
Substance:
POCARD Ltd. Moscow RU
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Status:
Valid
-
Issue Date:
2013-03-15
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Country:
Russia
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Certificate Number:
R1-CEP 2007-176 - Rev 00
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End Date:
-
Product:
Paclitaxel, Produced by a semi-synthetic process
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Type:
Chemical
-
Substance Number:
1794
-
Substance:
POLYMED THERAPEUTICS, INC. Houston US
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Status:
Valid
-
Issue Date:
2021-06-29
-
Country:
United States
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Certificate Number:
R1-CEP 2014-192 - Rev 00
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End Date:
-
Product:
Terlipressin
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Type:
Chemical
-
Substance Number:
2646
-
Substance:
POLYPEPTIDE LABORATORIES (SWEDEN) AB Limhamn SE
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Status:
Valid
-
Issue Date:
2026-05-04
-
Country:
Sweden
-
Certificate Number:
CEP 2019-316 - Rev 01
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End Date:
-
Product:
Hydroxychloroquine sulfate
-
Type:
Chemical
-
Substance Number:
2849
-
Substance:
PORTON PHARMA SOLUTIONS LTD. Changshou CN
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Status:
Valid
-
Issue Date:
2025-01-23
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Country:
China
-
Certificate Number:
CEP 2022-416 - Rev 00
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End Date:
-
Product:
Hydrochlorothiazide
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Type:
Chemical
-
Substance Number:
394
-
Substance:
Posh Chemicals Private Limited Hyderabad IN
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Status:
Expired
-
Issue Date:
2013-11-29
-
Country:
India
-
Certificate Number:
R0-CEP 2004-233 - Rev 01
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End Date:
2014-09-29
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