TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Simvastatin, Ethanol/acetonitrile Process
Certificate Number : R1-CEP 2013-216 - Rev 03
Status : Valid
Issue Date : 2022-11-28
Type : Chemical
Substance Number : 1563
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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 Tolue...
Certificate Number : R1-CEP 2003-257 - Rev 06
Status : Valid
Issue Date : 2019-11-21
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
Certificate Number : CEP 2012-337 - Rev 03
Status : Valid
Issue Date : 2024-01-26
Type : Chemical
Substance Number : 1563
Certificate Number : R1-CEP 2005-100 - Rev 06
Status : Valid
Issue Date : 2020-08-14
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, Process II, With Butylated Hydroxya...
Certificate Number : R0-CEP 2021-405 - Rev 00
Status : Valid
Issue Date : 2023-04-18
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
Certificate Number : CEP 2017-184 - Rev 03
Status : Valid
Issue Date : 2024-03-12
Type : Chemical and TSE
Substance Number : 1563
A Simvastatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Simvastatin, including repackagers and relabelers. The FDA regulates Simvastatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Simvastatin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Simvastatin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Simvastatin supplier is an individual or a company that provides Simvastatin active pharmaceutical ingredient (API) or Simvastatin finished formulations upon request. The Simvastatin suppliers may include Simvastatin API manufacturers, exporters, distributors and traders.
click here to find a list of Simvastatin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Simvastatin CEP of the European Pharmacopoeia monograph is often referred to as a Simvastatin Certificate of Suitability (COS). The purpose of a Simvastatin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Simvastatin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Simvastatin to their clients by showing that a Simvastatin CEP has been issued for it. The manufacturer submits a Simvastatin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Simvastatin CEP holder for the record. Additionally, the data presented in the Simvastatin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Simvastatin DMF.
A Simvastatin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Simvastatin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Simvastatin suppliers with CEP (COS) on PharmaCompass.
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