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DOSAGE - INJECTABLE;INJECTION - 4%; EQ 0.0085...DOSAGE - INJECTABLE;INJECTION - 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)
USFDA APPLICATION NUMBER - 20971
DOSAGE - INJECTABLE;INJECTION - 4%;EQ 0.017MG...DOSAGE - INJECTABLE;INJECTION - 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)
USFDA APPLICATION NUMBER - 20971
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PharmaCompass offers a list of Articaine Hydrochloride 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 Articaine Hydrochloride manufacturer or Articaine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Articaine Hydrochloride manufacturer or Articaine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Articaine Hydrochloride API Price utilized in the formulation of products. Articaine Hydrochloride API Price is not always fixed or binding as the Articaine Hydrochloride Price is obtained through a variety of data sources. The Articaine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Articaine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Articaine, including repackagers and relabelers. The FDA regulates Articaine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Articaine 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 Articaine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Articaine supplier is an individual or a company that provides Articaine active pharmaceutical ingredient (API) or Articaine finished formulations upon request. The Articaine suppliers may include Articaine API manufacturers, exporters, distributors and traders.
click here to find a list of Articaine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Articaine DMF (Drug Master File) is a document detailing the whole manufacturing process of Articaine active pharmaceutical ingredient (API) in detail. Different forms of Articaine DMFs exist exist since differing nations have different regulations, such as Articaine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Articaine DMF submitted to regulatory agencies in the US is known as a USDMF. Articaine USDMF includes data on Articaine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Articaine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Articaine 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 Articaine Drug Master File in Japan (Articaine JDMF) empowers Articaine 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 Articaine JDMF during the approval evaluation for pharmaceutical products. At the time of Articaine 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 Articaine 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 Articaine Drug Master File in Korea (Articaine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Articaine. The MFDS reviews the Articaine KDMF as part of the drug registration process and uses the information provided in the Articaine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Articaine 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 Articaine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Articaine suppliers with KDMF on PharmaCompass.
A Articaine CEP of the European Pharmacopoeia monograph is often referred to as a Articaine Certificate of Suitability (COS). The purpose of a Articaine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Articaine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Articaine to their clients by showing that a Articaine CEP has been issued for it. The manufacturer submits a Articaine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Articaine CEP holder for the record. Additionally, the data presented in the Articaine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Articaine DMF.
A Articaine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Articaine 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 Articaine suppliers with CEP (COS) on PharmaCompass.
A Articaine written confirmation (Articaine WC) is an official document issued by a regulatory agency to a Articaine manufacturer, verifying that the manufacturing facility of a Articaine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Articaine APIs or Articaine finished pharmaceutical products to another nation, regulatory agencies frequently require a Articaine WC (written confirmation) as part of the regulatory process.
click here to find a list of Articaine 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 Articaine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Articaine 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 Articaine 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 Articaine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Articaine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Articaine suppliers with NDC on PharmaCompass.
Articaine 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 Articaine 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 Articaine GMP manufacturer or Articaine GMP API supplier for your needs.
A Articaine CoA (Certificate of Analysis) is a formal document that attests to Articaine's compliance with Articaine specifications and serves as a tool for batch-level quality control.
Articaine CoA mostly includes findings from lab analyses of a specific batch. For each Articaine 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.
Articaine may be tested according to a variety of international standards, such as European Pharmacopoeia (Articaine EP), Articaine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Articaine USP).
