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  • TABLET;ORAL - EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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Looking for 134523-00-5 / Atorvastatin API manufacturers, exporters & distributors?

Atorvastatin manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Atorvastatin 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 Atorvastatin manufacturer or Atorvastatin supplier for your needs.

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

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

API | Excipient name

Atorvastatin

Synonyms

134523-00-5, Cardyl, Lipitor, 110862-48-1, Torvast, Atorvastatin calcium

Cas Number

134523-00-5

Unique Ingredient Identifier (UNII)

A0JWA85V8F

About Atorvastatin

A pyrrole and heptanoic acid derivative, HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITOR (statin), and ANTICHOLESTEREMIC AGENT that is used to reduce serum levels of LDL-CHOLESTEROL; APOLIPOPROTEIN B; and TRIGLYCERIDES. It is used to increase serum levels of HDL-CHOLESTEROL in the treatment of HYPERLIPIDEMIAS, and for the prevention of CARDIOVASCULAR DISEASES in patients with multiple risk factors.

Atorvastatin Sodium Manufacturers

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

Atorvastatin Sodium Suppliers

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

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

Atorvastatin Sodium USDMF

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

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

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

Atorvastatin Sodium 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 Atorvastatin Sodium Drug Master File in Japan (Atorvastatin Sodium JDMF) empowers Atorvastatin Sodium 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 Atorvastatin Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Atorvastatin Sodium 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 Atorvastatin Sodium suppliers with JDMF on PharmaCompass.

Atorvastatin Sodium KDMF

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

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

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

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

Atorvastatin Sodium CEP

A Atorvastatin Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Atorvastatin Sodium Certificate of Suitability (COS). The purpose of a Atorvastatin Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Atorvastatin Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Atorvastatin Sodium to their clients by showing that a Atorvastatin Sodium CEP has been issued for it. The manufacturer submits a Atorvastatin Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Atorvastatin Sodium CEP holder for the record. Additionally, the data presented in the Atorvastatin Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Atorvastatin Sodium DMF.

A Atorvastatin Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Atorvastatin Sodium 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 Atorvastatin Sodium suppliers with CEP (COS) on PharmaCompass.

Atorvastatin Sodium WC

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

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

Atorvastatin Sodium 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 Atorvastatin Sodium as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Atorvastatin Sodium 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 Atorvastatin Sodium 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 Atorvastatin Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Atorvastatin Sodium NDC to their finished compounded human drug products, they may choose to do so.

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

Atorvastatin Sodium GMP

Atorvastatin Sodium 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 Atorvastatin Sodium 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 Atorvastatin Sodium GMP manufacturer or Atorvastatin Sodium GMP API supplier for your needs.

Atorvastatin Sodium CoA

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

Atorvastatin Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Atorvastatin Sodium 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.

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