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Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
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Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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DOSAGE - TABLET;ORAL - 10MG **Federal Registe...DOSAGE - TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19898
DOSAGE - TABLET;ORAL - 20MG **Federal Registe...DOSAGE - TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19898
DOSAGE - TABLET;ORAL - 40MG **Federal Registe...DOSAGE - TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19898
DOSAGE - TABLET;ORAL - 80MG **Federal Registe...DOSAGE - TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19898
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Pravastatin 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 Pravastatin manufacturer or Pravastatin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pravastatin manufacturer or Pravastatin supplier.
PharmaCompass also assists you with knowing the Pravastatin API Price utilized in the formulation of products. Pravastatin API Price is not always fixed or binding as the Pravastatin Price is obtained through a variety of data sources. The Pravastatin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Pravaselect manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pravaselect, including repackagers and relabelers. The FDA regulates Pravaselect manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pravaselect 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 Pravaselect manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pravaselect supplier is an individual or a company that provides Pravaselect active pharmaceutical ingredient (API) or Pravaselect finished formulations upon request. The Pravaselect suppliers may include Pravaselect API manufacturers, exporters, distributors and traders.
click here to find a list of Pravaselect suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pravaselect DMF (Drug Master File) is a document detailing the whole manufacturing process of Pravaselect active pharmaceutical ingredient (API) in detail. Different forms of Pravaselect DMFs exist exist since differing nations have different regulations, such as Pravaselect USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pravaselect DMF submitted to regulatory agencies in the US is known as a USDMF. Pravaselect USDMF includes data on Pravaselect's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pravaselect USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pravaselect 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 Pravaselect Drug Master File in Japan (Pravaselect JDMF) empowers Pravaselect 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 Pravaselect JDMF during the approval evaluation for pharmaceutical products. At the time of Pravaselect 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 Pravaselect 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 Pravaselect Drug Master File in Korea (Pravaselect KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pravaselect. The MFDS reviews the Pravaselect KDMF as part of the drug registration process and uses the information provided in the Pravaselect KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pravaselect 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 Pravaselect API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pravaselect suppliers with KDMF on PharmaCompass.
A Pravaselect CEP of the European Pharmacopoeia monograph is often referred to as a Pravaselect Certificate of Suitability (COS). The purpose of a Pravaselect CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pravaselect EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pravaselect to their clients by showing that a Pravaselect CEP has been issued for it. The manufacturer submits a Pravaselect CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pravaselect CEP holder for the record. Additionally, the data presented in the Pravaselect CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pravaselect DMF.
A Pravaselect CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pravaselect 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 Pravaselect suppliers with CEP (COS) on PharmaCompass.
A Pravaselect written confirmation (Pravaselect WC) is an official document issued by a regulatory agency to a Pravaselect manufacturer, verifying that the manufacturing facility of a Pravaselect active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pravaselect APIs or Pravaselect finished pharmaceutical products to another nation, regulatory agencies frequently require a Pravaselect WC (written confirmation) as part of the regulatory process.
click here to find a list of Pravaselect 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 Pravaselect as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pravaselect 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 Pravaselect 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 Pravaselect and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pravaselect NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pravaselect suppliers with NDC on PharmaCompass.
Pravaselect 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 Pravaselect 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 Pravaselect GMP manufacturer or Pravaselect GMP API supplier for your needs.
A Pravaselect CoA (Certificate of Analysis) is a formal document that attests to Pravaselect's compliance with Pravaselect specifications and serves as a tool for batch-level quality control.
Pravaselect CoA mostly includes findings from lab analyses of a specific batch. For each Pravaselect 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.
Pravaselect may be tested according to a variety of international standards, such as European Pharmacopoeia (Pravaselect EP), Pravaselect JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pravaselect USP).
