API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
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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.
A Lipitor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lipitor, including repackagers and relabelers. The FDA regulates Lipitor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lipitor 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 Lipitor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lipitor supplier is an individual or a company that provides Lipitor active pharmaceutical ingredient (API) or Lipitor finished formulations upon request. The Lipitor suppliers may include Lipitor API manufacturers, exporters, distributors and traders.
click here to find a list of Lipitor suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lipitor DMF (Drug Master File) is a document detailing the whole manufacturing process of Lipitor active pharmaceutical ingredient (API) in detail. Different forms of Lipitor DMFs exist exist since differing nations have different regulations, such as Lipitor USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lipitor DMF submitted to regulatory agencies in the US is known as a USDMF. Lipitor USDMF includes data on Lipitor's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lipitor USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lipitor suppliers with USDMF on PharmaCompass.
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 Lipitor Drug Master File in Japan (Lipitor JDMF) empowers Lipitor 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 Lipitor JDMF during the approval evaluation for pharmaceutical products. At the time of Lipitor 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 Lipitor suppliers with JDMF 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 Lipitor Drug Master File in Korea (Lipitor KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lipitor. The MFDS reviews the Lipitor KDMF as part of the drug registration process and uses the information provided in the Lipitor KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lipitor 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 Lipitor API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lipitor suppliers with KDMF on PharmaCompass.
A Lipitor CEP of the European Pharmacopoeia monograph is often referred to as a Lipitor Certificate of Suitability (COS). The purpose of a Lipitor CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lipitor EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lipitor to their clients by showing that a Lipitor CEP has been issued for it. The manufacturer submits a Lipitor CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lipitor CEP holder for the record. Additionally, the data presented in the Lipitor CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lipitor DMF.
A Lipitor CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lipitor 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 Lipitor suppliers with CEP (COS) on PharmaCompass.
A Lipitor written confirmation (Lipitor WC) is an official document issued by a regulatory agency to a Lipitor manufacturer, verifying that the manufacturing facility of a Lipitor active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lipitor APIs or Lipitor finished pharmaceutical products to another nation, regulatory agencies frequently require a Lipitor WC (written confirmation) as part of the regulatory process.
click here to find a list of Lipitor suppliers with Written Confirmation (WC) on PharmaCompass.
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 Lipitor as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lipitor API and other APIs are published in this directory by the FDA.
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 Lipitor 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.
The NDC directory also contains data on finished compounded human drug products that contain Lipitor and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lipitor NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lipitor suppliers with NDC on PharmaCompass.
Lipitor 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 Lipitor 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 Lipitor GMP manufacturer or Lipitor GMP API supplier for your needs.
A Lipitor CoA (Certificate of Analysis) is a formal document that attests to Lipitor's compliance with Lipitor specifications and serves as a tool for batch-level quality control.
Lipitor CoA mostly includes findings from lab analyses of a specific batch. For each Lipitor 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.
Lipitor may be tested according to a variety of international standards, such as European Pharmacopoeia (Lipitor EP), Lipitor JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lipitor USP).