01 1ARTEMIS BIOTECH LIMITED Hyderabad IN
02 1AUROBINDO PHARMA LIMITED Hyderabad IN
03 3Artemis Biotech (A Division of Themis Medicare Limited) Hyderabad IN
04 2BIOCON LIMITED Bangalore IN
05 2BIOCON LIMITED Bengaluru IN
06 1CONCORD BIOTECH LIMITED Ahmedabad IN
07 2HENAN TOPFOND SCI-TECH CO., LTD. Zhumadian CN
08 1HETERO LABS LIMITED Hyderabad IN
09 1HOVIONE FARMACIENCIA S.A. Loures PT
10 1JUBILANT PHARMOVA LIMITED Nanjangud IN
11 2KREBS BIOCHEMICALS & INDUSTRIES LIMITED Kothapalli IN
12 2KRKA, d.d., Novo mesto Novo mesto SI
13 1LEK PHARMACEUTICALS D.D. Ljubljana SI
14 1LUPIN LIMITED Mumbai IN
15 1Merck Sharp & Dohme (Europe) Inc. Brussels BE
16 2SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN
17 1SOUTHWEST SYNTHETIC PHARMACEUTICAL CORPORATION, LIMITED Chongqing CN
18 1STERLING BIOTECH LIMITED Masar Village IN
19 1SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN
20 1Sandoz Industrial Products SpA Rovereto IT
21 1TEVA PHARMACEUTICAL INDUSTRIES LTD Petach Tikva IL
22 4TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL
23 1ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO., LTD. Hengdian CN
24 2ZHEJIANG JIANGBEI NANHAI PHARMACEUTICAL CO., LTD Linhai City CN
25 4ZHEJIANG JIANGBEI PHARMACEUTICAL CO., LTD. Taizhou City CN
26 2Zhejiang Hisun Pharmaceutical Co., Ltd. Taizhou City CN
01 23Simvastatin
02 1Simvastatin, Antioxidant Butylated Hydroxy Toluene 0.01%
03 1Simvastatin, Antioxidant butylated hydroxyanisole
04 1Simvastatin, Antioxidant butylhydroxyanisole
05 1Simvastatin, BHA process
06 1Simvastatin, Butylated Hydroxy Anisole 50 - 150 ppm
07 2Simvastatin, Butylated Hydroxyanisole 0.01%
08 1Simvastatin, Butylated hydroxy anisole 0.18-0.22%
09 1Simvastatin, Butylated hydroxyanisole 0.01%, Process II
10 1Simvastatin, Ethanol II process
11 1Simvastatin, Ethanol process
12 1Simvastatin, Ethanol/acetonitrile process
13 1Simvastatin, Ethanol/acetonitrile/BHA process
14 1Simvastatin, Process II
15 1Simvastatin, Process II, Antioxidant Butylated Hydroxy Toluene 0.01%
16 1Simvastatin, Process II, with butylated hydroxyanisole 0.010%
17 1Simvastatin, With butylated hydroxyanisole
18 1Simvastatin, With butylated hydroxyanisole 0.010%
19 1Simvastatin, with 0.2% butylated hydroxy anisole
01 1Brazil
02 14China
03 1Germany
04 17India
05 5Israel
06 1Portugal
07 3Slovenia
01 2Expired
02 27Valid
03 1Withdrawn by EDQM Failure to CEP procedure
04 12Withdrawn by Holder
Simvastatin, Butylated Hydroxy Anisole 50 - 150 ppm
Certificate Number : R1-CEP 2006-091 - Rev 03
Status : Valid
Issue Date : 2020-05-07
Type : Chemical
Substance Number : 1563
Certificate Number : CEP 2012-337 - Rev 03
Status : Valid
Issue Date : 2024-01-26
Type : Chemical
Substance Number : 1563
Simvastatin, Antioxidant butylhydroxyanisole
Certificate Number : R1-CEP 2011-323 - Rev 01
Status : Valid
Issue Date : 2019-11-06
Type : Chemical
Substance Number : 1563
Certificate Number : R1-CEP 2006-232 - Rev 04
Status : Valid
Issue Date : 2022-03-15
Type : Chemical
Substance Number : 1563
Certificate Number : R1-CEP 2004-051 - Rev 04
Status : Valid
Issue Date : 2023-04-18
Type : Chemical
Substance Number : 1563
Simvastatin, Ethanol/acetonitrile process
Certificate Number : R1-CEP 2013-216 - Rev 03
Status : Valid
Issue Date : 2022-11-28
Type : Chemical
Substance Number : 1563
Simvastatin, Ethanol II process
Certificate Number : R0-CEP 2019-179 - Rev 01
Status : Valid
Issue Date : 2021-12-20
Type : Chemical
Substance Number : 1563
Simvastatin, Process II, with butylated hydroxyanisole 0.010%
Certificate Number : R0-CEP 2021-405 - Rev 00
Status : Valid
Issue Date : 2023-04-18
Type : Chemical
Substance Number : 1563
Certificate Number : R0-CEP 2021-401 - Rev 00
Status : Valid
Issue Date : 2023-04-19
Type : Chemical
Substance Number : 1563
Certificate Number : CEP 2005-300 - Rev 06
Status : Valid
Issue Date : 2024-01-26
Type : Chemical and TSE
Substance Number : 1563
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