Simvastatin

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.

Simvastatin Manufacturers

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.

Simvastatin Suppliers

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.

Simvastatin KDMF

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.

Simvastatin Manufacturers | Traders | Suppliers

We have 16 companies offering Simvastatin

Get in contact with the supplier of your choice:

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.

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

Simvastatin

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

71 Suppliers

39 USDMF

40 CEP/COS

6 JDMF

10 EU WC

53 KDMF

12 NDC API

18 Listed Suppliers

DEVELOPMENTS

2 Drug(s) in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

DOSSIERs // Finished Dosage Forms

787 Dossiers

128 FDA Orange Book

384 Europe

65 Canada

62 Australia

81 South Africa

67 Listed Dossiers

DRUG PRODUCT COMPOSITION

TABLET;ORAL - 10MG

TABLET;ORAL - 20MG

TABLET;ORAL - 40MG

TABLET;ORAL - 5MG

TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SUSPENSION;ORAL - 20MG/5ML

SUSPENSION;ORAL - 40MG/5ML

TABLET;ORAL - 10MG;10MG

TABLET;ORAL - 10MG;20MG

TABLET;ORAL - 10MG;40MG

TABLET;ORAL - 10MG;80MG

RELATED EXCIPIENT COMPANIES

Suppliers

36 Kerry

26 BASF

18 Roquette

17 Microlex e.U

11 Sigachi Industries

10 Corel Pharma Chem

9 Gangwal Healthcare

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

8 Gangwal Chemicals

7 Seppic

6 DFE Pharma

6 Lonza Capsugel

5 SPI Pharma

5 Nanjing Well Pharmaceutical

5 Ideal Cures Pvt Ltd

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

4 Kima Chemical

3 Ingredion Pharma Solutions

3 Prachin Chemical

3 The Dow Chemical Company

3 Actylis

3 Vasa Pharmachem

2 Aeon Procare

2 Rochem International Inc

2 Seqens

2 Finar

2 Nomisma Healthcare

2 Pharmatrans-Sanaq

1 Pharm-RX Chemical

1 Qualicaps

1 DKSH

1 Boai NKY Pharmaceuticals Ltd

1 Minakem

1 Qianhao Chemical (Hebei) Co., Ltd

1 Ulanqab Kema New Material

1 Vertellus

1 Avesta Pharma

TABLET;ORAL - 80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons