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