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  • TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

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 USDMF

A Simvastatin DMF (Drug Master File) is a document detailing the whole manufacturing process of Simvastatin active pharmaceutical ingredient (API) in detail. Different forms of Simvastatin DMFs exist exist since differing nations have different regulations, such as Simvastatin USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Simvastatin DMF submitted to regulatory agencies in the US is known as a USDMF. Simvastatin USDMF includes data on Simvastatin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Simvastatin USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Simvastatin suppliers with USDMF on PharmaCompass.

Simvastatin JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Simvastatin Drug Master File in Japan (Simvastatin JDMF) empowers Simvastatin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Simvastatin JDMF during the approval evaluation for pharmaceutical products. At the time of Simvastatin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Simvastatin suppliers with JDMF 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 CEP

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.

Simvastatin WC

A Simvastatin written confirmation (Simvastatin WC) is an official document issued by a regulatory agency to a Simvastatin manufacturer, verifying that the manufacturing facility of a Simvastatin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Simvastatin APIs or Simvastatin finished pharmaceutical products to another nation, regulatory agencies frequently require a Simvastatin WC (written confirmation) as part of the regulatory process.

click here to find a list of Simvastatin suppliers with Written Confirmation (WC) on PharmaCompass.

Simvastatin NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Simvastatin as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Simvastatin API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Simvastatin as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Simvastatin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Simvastatin NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Simvastatin suppliers with NDC on PharmaCompass.

Simvastatin GMP

Simvastatin Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

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

Simvastatin CoA

A Simvastatin CoA (Certificate of Analysis) is a formal document that attests to Simvastatin's compliance with Simvastatin specifications and serves as a tool for batch-level quality control.

Simvastatin CoA mostly includes findings from lab analyses of a specific batch. For each Simvastatin CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Simvastatin may be tested according to a variety of international standards, such as European Pharmacopoeia (Simvastatin EP), Simvastatin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Simvastatin USP).

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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