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01 1TEVA PHARMACEUTICAL INDUSTRIES LTD Petach Tikva IL
02 4TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL
03 1ARTEMIS BIOTECH LIMITED Hyderabad IN
04 1AUROBINDO PHARMA LIMITED Hyderabad IN
05 3Artemis Biotech (A Division of Themis Medicare Limited) Hyderabad IN
06 2BIOCON LIMITED Bangalore IN
07 2BIOCON LIMITED Bengaluru IN
08 1CONCORD BIOTECH LIMITED Ahmedabad IN
09 2HENAN TOPFOND SCI-TECH CO., LTD. Zhumadian CN
10 1HETERO LABS LIMITED Hyderabad IN
11 1HOVIONE FARMACIENCIA S.A. Loures PT
12 1JUBILANT PHARMOVA LIMITED Nanjangud IN
13 2KREBS BIOCHEMICALS & INDUSTRIES LIMITED Kothapalli IN
14 2KRKA, d.d., Novo mesto Novo mesto SI
15 1LEK PHARMACEUTICALS D.D. Ljubljana SI
16 1LUPIN LIMITED Mumbai IN
17 1Merck Sharp & Dohme (Europe) Inc. Brussels BE
18 2SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN
19 1SOUTHWEST SYNTHETIC PHARMACEUTICAL CORPORATION, LIMITED Chongqing CN
20 1STERLING BIOTECH LIMITED Masar Village IN
21 1SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN
22 1Sandoz Industrial Products SpA Rovereto IT
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, Ethanol/acetonitrile process
Certificate Number : R1-CEP 2013-216 - Rev 03
Status : Valid
Issue Date : 2022-11-28
Type : Chemical
Substance Number : 1563
Certificate Number : R1-CEP 2001-076 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2013-05-03
Type : Chemical
Substance Number : 1563
Simvastatin, Antioxidant Butylated Hydroxy Toluene 0.01%
Certificate Number : R1-CEP 2003-257 - Rev 06
Status : Valid
Issue Date : 2019-11-21
Type : Chemical
Substance Number : 1563
Simvastatin, Process II, Antioxidant Butylated Hydroxy Toluene 0.01%
Certificate Number : CEP 2023-416 - Rev 00
Status : Valid
Issue Date : 2024-04-02
Type : Chemical
Substance Number : 1563
Certificate Number : R1-CEP 2005-159 - Rev 03
Status : Valid
Issue Date : 2019-03-29
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
Simvastatin, with 0.2% butylated hydroxy anisole
Certificate Number : R1-CEP 2007-210 - Rev 02
Status : Valid
Issue Date : 2023-08-11
Type : Chemical
Substance Number : 1563
Certificate Number : R1-CEP 2001-384 - Rev 08
Status : Valid
Issue Date : 2019-04-10
Type : Chemical
Substance Number : 1563
Simvastatin, With butylated hydroxyanisole 0.010%
Certificate Number : CEP 2022-266 - Rev 01
Status : Valid
Issue Date : 2024-07-05
Type : Chemical
Substance Number : 1563
Certificate Number : CEP 2022-245 - Rev 01
Status : Valid
Issue Date : 2024-07-03
Type : Chemical
Substance Number : 1563
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