01 1AUROBINDO PHARMA LIMITED
02 1Artemis Biotech (A Division of Themis Medicare Ltd)
03 2Aurobindo Pharma Limited
04 9Biocon Limited
05 1Krebs Biochemicals & Industries Limited
06 1Kyungbo Pharmaceutical Co., Ltd.
07 1LUPIN Limited
08 1Lupin Limited
09 2M/s Hetero Labs Limited
10 1MSD International GmbH (Singapore Branch)
11 1MSD International GmbH@Divi's Laboratories Limited (Unit-2)
12 1Merck Sharp & Dohme Ltd
13 1Sandoz Industrial Products SpA
14 3Shangyu Jingxin Pharmaceutical Co., Ltd. Ltd
15 2Shaoxing Jingxin Pharmaceutical Co., Ltd. Ltd@Livzon Group (Ningxia) Pharmaceutical Co., Ltd.
16 1Shaoxing Jingxin Pharmaceutical Co., Ltd.@Livzon Group (Ningxia) Pharmaceutical Co.,Ltd.
17 1TEVA Pharmaceutical Works Company Limited@Sterling Biotech Limited@Livzon Group (Ningxia) Pharmaceutical Co.,Ltd.
18 1Trustee: Samoh Pharmaceutical
19 1Zhejiang Apeloa Pharmaceutical Co., Ltd
20 1Zhejiang Hisun Pharmaceutical Co., Ltd.
21 1Zhejiang Jiangbei Pharm Co., Ltd
22 2Zhejiang Jiangbei Pharm Co., Ltd.
23 1Zhejiang Jiangbei Pharmaceutical Co.,Ltd@Chongqing Daxin@Sterling Biotech Limited
24 1Zhejiang Jiangbei Pharmaceutical Co.,Ltd@Starting material 'Lovastatin' manufacturer ① Chongqing Daxin@Starting material 'Lovastatin' manufacturer ② Sterling Biotech Limited
25 1Zhejiang jiangbei Pharm Co.,Ltd.
26 1Zhejiang jiangbei Pharm Co.,Ltd.@[Starting material 'Lovastatin manufacturer①] Chongquing Daxin@[Starting material Lovastatin manufacturer② Sterling Biotech Limited]
27 1Zhejiang jiangbei Pharm Co.ltd
28 2Zhejiang jiangbei Pharm Co.ltd@Starting material 'Lovastatin' manufacturer ① Chongqing Daxin@Starting material 'Lovastatin' manufacturer ② Sterling Biotech Limited
29 1Zhejiang jiangbei Pharm Co.ltd@[Starting material 'Lovastatin manufacturer①] Chongquing Daxin@[Starting material Lovastatin manufacturer② Sterling Biotech Limited]
01 1Abbott Korea Ltd.
02 1Ace Biopharm Co., Ltd.
03 4Daeshin Pharmaceutical Co., Ltd.
04 1Dong-A ST Co., Ltd.
05 1Gapi Bio Co., Ltd.
06 1Hanapharmaceutical Co., Ltd.
07 1Hanjin Pharmaceutical
08 1Hanyoung Farm Co., Ltd.
09 1Hiple Co., Ltd.
10 1Hwail Pharmaceutical Co., Ltd.
11 2KR Pharm Co., Ltd.
12 1Korea Chorus Co., Ltd.
13 3Korea Organon Co., Ltd.
14 2Korea United Pharmaceutical Co., Ltd.
15 2Kukjeon Pharmaceutical Co., Ltd.
16 1Kyungbo Pharmaceutical Co., Ltd.
17 1Lee Sung International Co., Ltd.
18 1Lihu Healthcare Co., Ltd.
19 2Masung LS Co., Ltd.
20 1Pharmapia Co., Ltd.
21 1Renew Medical Co., Ltd.
22 1SG Biochem Co., Ltd.
23 2Sale Pharmaceutical Co., Ltd.
24 2Samoh Pharmaceutical Co., Ltd.
25 1Seongi Bio Co., Ltd.
26 4Sungwoo Chemical Co., Ltd.
27 1Toru Corporation
28 1Youngpoong Pharmaceutical Co., Ltd.
29 2Yuhan Corporation
01 44Simvastatin
01 19China
02 17India
03 1Israel
04 1South Korea
05 1Switzerland
06 3U.S.A
07 1Uzbekistan
08 1Blank
Registrant Name : Abbott Korea Ltd.
Registration Date : 2020-09-29
Registration Number : 20200929-29-B-437-28
Manufacturer Name : Krebs Biochemicals & Industr...
Manufacturer Address : Survey No. 157& 158, Kothapalli(V), Kasimkota(M) Visakhapatnam District Andhra Prades...
Registrant Name : Lihu Healthcare Co., Ltd.
Registration Date : 2018-04-11
Registration Number : 20180411-29-B-409-27
Manufacturer Name : Zhejiang Hisun Pharmaceutica...
Manufacturer Address : 56 Binhai Road, Jiaojiang District, Taizhou City, Zhejiang Province 318000
Registrant Name : Hanjin Pharmaceutical
Registration Date : 2016-11-14
Registration Number : 20120217-29-B-327-26(9)
Manufacturer Name : Zhejiang Jiangbei Pharm Co.,...
Manufacturer Address : Dongdai village Zhang an Street, Jiaojiang, Taizhlu, Zhejiang, China
Registrant Name : Renew Medical Co., Ltd.
Registration Date : 2021-07-07
Registration Number : 20120217-29-B-327-26(12)
Manufacturer Name : Zhejiang jiangbei Pharm Co.l...
Manufacturer Address : Dongdai village Zhang an Street, Jiaojiang, Taizhou, Zhejiang @Starting material 'Lov...
Registrant Name : Hanyoung Farm Co., Ltd.
Registration Date : 2021-04-06
Registration Number : 20120217-29-B-327-26(11)
Manufacturer Name : Zhejiang Jiangbei Pharmaceut...
Manufacturer Address : Dongdai Zhang'an Street Jiaojiang Taizhou City, China@Starting material 'Lovastatin' ...
Registrant Name : Gapi Bio Co., Ltd.
Registration Date : 2020-05-19
Registration Number : 20120217-29-B-327-26(10)
Manufacturer Name : Zhejiang Jiangbei Pharmaceut...
Manufacturer Address : Dongdai Zhang'an Street Jiaojiang Taizhou City, China@No.21 . Founder Road, Shuitu To...
Registrant Name : Hiple Co., Ltd.
Registration Date : 2016-05-02
Registration Number : 20120217-29-B-327-26(8)
Manufacturer Name : Zhejiang Jiangbei Pharm Co.,...
Manufacturer Address : Dongdai village Zhang an Street, Jiaojiang, Taizhlu, Zhejiang
Registrant Name : Toru Corporation
Registration Date : 2021-10-26
Registration Number : 20100930-29-B-306-24(6)
Manufacturer Name : Shaoxing Jingxin Pharmaceuti...
Manufacturer Address : No.31, Weisan Road, Hangzhou Bay Shangyu Economic and Technological Development Area,...
Registrant Name : Daeshin Pharmaceutical Co., Ltd.
Registration Date : 2015-03-13
Registration Number : 20100930-29-B-306-24(3)
Manufacturer Name : Shangyu Jingxin Pharmaceutic...
Manufacturer Address : No 31, Weisan Road, Hangzhou Bay, Shangyu Economic and Technological Development Area...
Registrant Name : Korea United Pharmaceutical Co., Ltd.
Registration Date : 2018-02-02
Registration Number : 20100930-29-B-306-24(5)
Manufacturer Name : Shangyu Jingxin Pharmaceutic...
Manufacturer Address : No 31, Weisan Road, Hangzhou Bay, Shangyu Economic and Technological Development Area
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.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Simvastatin Drug Master File in Korea (Simvastatin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Simvastatin. The MFDS reviews the Simvastatin KDMF as part of the drug registration process and uses the information provided in the Simvastatin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Simvastatin KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Simvastatin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Simvastatin suppliers with KDMF on PharmaCompass.
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