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List of Drug Master Files (KDMF) for Tox21_300400 Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 AUROBINDO PHARMA LIMITED (1)

02 Artemis Biotech (A Division of Themis Medicare Ltd) (1)

03 Aurobindo Pharma Limited (2)

04 Biocon Limited (11)

05 Biocon Limited@Hwail Pharmaceutical Co., Ltd. (1)

06 Boryung Pharmaceutical Co., Ltd. (1)

07 Daewoong Bio Co., Ltd. (1)

08 Krebs Biochemicals & Industries Limited (1)

09 Kyungbo Pharmaceutical Co., Ltd. (1)

10 LUPIN Limited (3)

11 Lupine Limited (2)

12 M/s Hetero Labs Limited (2)

13 MSD International GmbH (Singapore Branch) (1)

14 MSD International GmbH@[Manufacturer of key intermediate (Simvastatin Ammonium Salt)①] Merck & Co., Inc. (Flint River Plant)@[Manufacturer of key intermediate (Simvastatin Ammonium Salt)②] Divi's Laboratories Limited (Unit-2) (1)

15 Merck Sharp & Dohme Ltd (1)

16 Sandoz Industrial Products SpA (1)

17 Shangyu Jingxin Pharmaceutical Co., Ltd (1)

18 Shangyu Jingxin Pharmaceutical Co., Ltd. (1)

19 Shangyu Jingxin Pharmaceutical Co., Ltd. Ltd (4)

20 Shaoxing Jingxin Pharmaceutical Co. Ltd@Livzon Group (Ningxia) Pharmaceutical Co., Ltd. (1)

21 TEVA Pharmaceutical Works Company Limited@Sterling Biotech Limited@Livzon Group (Ningxia) Pharmaceutical Co.,Ltd. (1)

22 Trustee: Samo Pharmaceutical (1)

23 Zhejiang Apeloa Pharmaceutical Co., Ltd (1)

24 Zhejiang Hisun Pharmaceutical Co., Ltd. (1)

25 Zhejiang Jiangbei Pharm Co., Ltd (1)

26 Zhejiang Jiangbei Pharm Co., Ltd. (2)

27 Zhejiang Jiangbei Pharmaceutical Co.,Ltd@Chongqing Daxin@Sterling Biotech Limited (1)

28 Zhejiang Jiangbei Pharmaceutical Co.,Ltd@Manufacturer of starting material 'Lovastatin' ① Chongqing Daxin@Manufacturer of starting material 'Lovastatin' ② Sterling Biotech Limited (1)

29 Zhejiang jiangbei Pharm Co.,Ltd. (1)

30 Zhejiang jiangbei Pharm Co.,Ltd.@[Starting material lovastatin manufacturer ①] Chongquing Daxin@[Starting material lovastatin manufacturer ② Sterling Biotech Limited] (1)

31 Zhejiang jiangbei Pharm Co.ltd (1)

32 Zhejiang jiangbei Pharm Co.ltd@Manufacturer of starting material 'Lovastatin' ① Chongqing Daxin@Manufacturer of starting material 'Lovastatin' ② Sterling Biotech Limited (2)

33 Zhejiang jiangbei Pharm Co.ltd@[Starting material lovastatin manufacturer ①] Chongquing Daxin@[Starting material lovastatin manufacturer ② Sterling Biotech Limited] (1)

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01 Abbott Korea Co., Ltd. (1)

02 Ace Biopharm Co., Ltd. (1)

03 Boryeong Co., Ltd. (2)

04 Daesin Pharmaceutical Co., Ltd. (4)

05 Daewoong Bio Co., Ltd. (1)

06 Donga ST Co., Ltd. (1)

07 Gapi Bio Co., Ltd. (1)

08 Hana Pharmaceutical Co., Ltd. (1)

09 Hanjin Pharmaceutical (1)

10 Hanmi Pharmaceutical Co., Ltd. (1)

11 Hanyoung Farm Co., Ltd. (1)

12 Hiple Co., Ltd. (1)

13 Hwail Pharmaceutical Co., Ltd. (3)

14 KR Farm Co., Ltd. (2)

15 Kookjeon Pharmaceutical Co., Ltd. (2)

16 Korea Chorus Co., Ltd. (1)

17 Korea Organon Co., Ltd. (3)

18 Korea United Pharmaceutical Co., Ltd. (2)

19 Kyungbo Pharmaceutical Co., Ltd. (1)

20 Leesung International Co., Ltd. (1)

21 Lihu Healthcare Co., Ltd. (1)

22 Masung LS Co., Ltd. (2)

23 Narsha Farm Co., Ltd. (1)

24 Pharmapia Co., Ltd. (2)

25 Renew Medical Co., Ltd. (1)

26 SG Biochem Co., Ltd. (1)

27 Samo Pharmaceutical Co., Ltd. (2)

28 Seil Pharmaceutical Co., Ltd. (2)

29 Seongui Bio Co., Ltd. (1)

30 Sungwoo Chemical Co., Ltd. (5)

31 Toru Co., Ltd. (1)

32 Youngpoong Pharmaceutical Co., Ltd. (1)

33 Yuhan Corporation (2)

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01 Simvastatin (53)

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01 China (20)

02 India (23)

03 Israel (1)

04 South Korea (3)

05 Switzerland (1)

06 U.S.A (3)

07 Uzbekistan (1)

08 Blank (1)

URL Supplier Web Content
Abbott Korea Co., Ltd.
2020-09-29
20200929-29-B-437-28
Krebs Biochemicals & Indu...
India
Survey No. 157& 158, Koth...
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Lihu Healthcare Co., Ltd.
2018-04-11
20180411-29-B-409-27
Zhejiang Hisun Pharmaceut...
China
56 Binhai Road, Jiaojiang...
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Hiple Co., Ltd.
2016-05-02
20120217-29-B-327-26(8)
Zhejiang Jiangbei Pharm C...
China
Dongdai village Zhang an ...
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Renew Medical Co., Ltd.
2021-07-07
20120217-29-B-327-26(12)
Zhejiang jiangbei Pharm C...
China
Dongdai village Zhang an ...
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Hanjin Pharmaceutical
2016-11-14
20120217-29-B-327-26(9)
Zhejiang Jiangbei Pharm C...
China
Dongdai village Zhang an ...
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Hanyoung Farm Co., Ltd.
2021-04-06
20120217-29-B-327-26(11)
Zhejiang Jiangbei Pharmac...
China
Dongdai Zhang'an Street J...
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Gapi Bio Co., Ltd.
2020-05-19
20120217-29-B-327-26(10)
Zhejiang Jiangbei Pharmac...
China
Dongdai Zhang'an Street J...
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Toru Co., Ltd.
2021-10-26
20100930-29-B-306-24(6)
Shangyu Jingxin Pharmaceu...
China
No 31, Weisan Road, Hangz...
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Narsha Farm Co., Ltd.
2016-11-22
20100930-29-B-306-24(4)
Shangyu Jingxin Pharmaceu...
China
No 31, Weisan Road, Zheji...
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Korea United Pharmaceutical Co., Ltd.
2018-02-02
20100930-29-B-306-24(5)
Shangyu Jingxin Pharmaceu...
China
No 31, Weisan Road, Hangz...
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Looking for 79902-63-9 / Simvastatin API manufacturers, exporters & distributors?

Simvastatin manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Simvastatin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Simvastatin manufacturer or Simvastatin supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Simvastatin manufacturer or Simvastatin supplier.

PharmaCompass also assists you with knowing the Simvastatin API Price utilized in the formulation of products. Simvastatin API Price is not always fixed or binding as the Simvastatin Price is obtained through a variety of data sources. The Simvastatin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Simvastatin

Synonyms

79902-63-9, Zocor, Synvinolin, Mk-733, Sinvacor, Denan

Cas Number

79902-63-9

Unique Ingredient Identifier (UNII)

AGG2FN16EV

About Simvastatin

A derivative of LOVASTATIN and potent competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It may also interfere with steroid hormone production. Due to the induction of hepatic LDL RECEPTORS, it increases breakdown of LDL CHOLESTEROL.

Tox21_300400 Manufacturers

A Tox21_300400 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tox21_300400, including repackagers and relabelers. The FDA regulates Tox21_300400 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tox21_300400 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 Tox21_300400 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Tox21_300400 Suppliers

A Tox21_300400 supplier is an individual or a company that provides Tox21_300400 active pharmaceutical ingredient (API) or Tox21_300400 finished formulations upon request. The Tox21_300400 suppliers may include Tox21_300400 API manufacturers, exporters, distributors and traders.

click here to find a list of Tox21_300400 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Tox21_300400 KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Tox21_300400 Drug Master File in Korea (Tox21_300400 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tox21_300400. The MFDS reviews the Tox21_300400 KDMF as part of the drug registration process and uses the information provided in the Tox21_300400 KDMF to evaluate the safety and efficacy of the drug.

After submitting a Tox21_300400 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 Tox21_300400 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Tox21_300400 suppliers with KDMF on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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