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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - 0.5MG
USFDA APPLICATION NUMBER - 21797
DOSAGE - TABLET;ORAL - 1MG
USFDA APPLICATION NUMBER - 21797
DOSAGE - SOLUTION;ORAL - 0.05MG/ML
USFDA APPLICATION NUMBER - 21798
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ABOUT THIS PAGE
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PharmaCompass offers a list of Entecavir 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 Entecavir manufacturer or Entecavir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Entecavir manufacturer or Entecavir supplier.
PharmaCompass also assists you with knowing the Entecavir API Price utilized in the formulation of products. Entecavir API Price is not always fixed or binding as the Entecavir Price is obtained through a variety of data sources. The Entecavir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A AC-1593 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AC-1593, including repackagers and relabelers. The FDA regulates AC-1593 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AC-1593 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 AC-1593 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A AC-1593 supplier is an individual or a company that provides AC-1593 active pharmaceutical ingredient (API) or AC-1593 finished formulations upon request. The AC-1593 suppliers may include AC-1593 API manufacturers, exporters, distributors and traders.
click here to find a list of AC-1593 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A AC-1593 DMF (Drug Master File) is a document detailing the whole manufacturing process of AC-1593 active pharmaceutical ingredient (API) in detail. Different forms of AC-1593 DMFs exist exist since differing nations have different regulations, such as AC-1593 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A AC-1593 DMF submitted to regulatory agencies in the US is known as a USDMF. AC-1593 USDMF includes data on AC-1593's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AC-1593 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of AC-1593 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 AC-1593 Drug Master File in Japan (AC-1593 JDMF) empowers AC-1593 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 AC-1593 JDMF during the approval evaluation for pharmaceutical products. At the time of AC-1593 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 AC-1593 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 AC-1593 Drug Master File in Korea (AC-1593 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of AC-1593. The MFDS reviews the AC-1593 KDMF as part of the drug registration process and uses the information provided in the AC-1593 KDMF to evaluate the safety and efficacy of the drug.
After submitting a AC-1593 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 AC-1593 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of AC-1593 suppliers with KDMF on PharmaCompass.
A AC-1593 CEP of the European Pharmacopoeia monograph is often referred to as a AC-1593 Certificate of Suitability (COS). The purpose of a AC-1593 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of AC-1593 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of AC-1593 to their clients by showing that a AC-1593 CEP has been issued for it. The manufacturer submits a AC-1593 CEP (COS) as part of the market authorization procedure, and it takes on the role of a AC-1593 CEP holder for the record. Additionally, the data presented in the AC-1593 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the AC-1593 DMF.
A AC-1593 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. AC-1593 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 AC-1593 suppliers with CEP (COS) on PharmaCompass.
A AC-1593 written confirmation (AC-1593 WC) is an official document issued by a regulatory agency to a AC-1593 manufacturer, verifying that the manufacturing facility of a AC-1593 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting AC-1593 APIs or AC-1593 finished pharmaceutical products to another nation, regulatory agencies frequently require a AC-1593 WC (written confirmation) as part of the regulatory process.
click here to find a list of AC-1593 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 AC-1593 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for AC-1593 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 AC-1593 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 AC-1593 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a AC-1593 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of AC-1593 suppliers with NDC on PharmaCompass.
AC-1593 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 AC-1593 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 AC-1593 GMP manufacturer or AC-1593 GMP API supplier for your needs.
A AC-1593 CoA (Certificate of Analysis) is a formal document that attests to AC-1593's compliance with AC-1593 specifications and serves as a tool for batch-level quality control.
AC-1593 CoA mostly includes findings from lab analyses of a specific batch. For each AC-1593 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.
AC-1593 may be tested according to a variety of international standards, such as European Pharmacopoeia (AC-1593 EP), AC-1593 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (AC-1593 USP).
