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