Synopsis
0
VMF
0
Australia
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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
Related Excipient Companies
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
58
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 Carticain manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carticain, including repackagers and relabelers. The FDA regulates Carticain manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carticain 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 Carticain manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Carticain supplier is an individual or a company that provides Carticain active pharmaceutical ingredient (API) or Carticain finished formulations upon request. The Carticain suppliers may include Carticain API manufacturers, exporters, distributors and traders.
click here to find a list of Carticain suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Carticain DMF (Drug Master File) is a document detailing the whole manufacturing process of Carticain active pharmaceutical ingredient (API) in detail. Different forms of Carticain DMFs exist exist since differing nations have different regulations, such as Carticain USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Carticain DMF submitted to regulatory agencies in the US is known as a USDMF. Carticain USDMF includes data on Carticain's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Carticain USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Carticain 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 Carticain Drug Master File in Japan (Carticain JDMF) empowers Carticain 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 Carticain JDMF during the approval evaluation for pharmaceutical products. At the time of Carticain 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 Carticain 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 Carticain Drug Master File in Korea (Carticain KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Carticain. The MFDS reviews the Carticain KDMF as part of the drug registration process and uses the information provided in the Carticain KDMF to evaluate the safety and efficacy of the drug.
After submitting a Carticain 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 Carticain API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Carticain suppliers with KDMF on PharmaCompass.
A Carticain CEP of the European Pharmacopoeia monograph is often referred to as a Carticain Certificate of Suitability (COS). The purpose of a Carticain CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Carticain EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Carticain to their clients by showing that a Carticain CEP has been issued for it. The manufacturer submits a Carticain CEP (COS) as part of the market authorization procedure, and it takes on the role of a Carticain CEP holder for the record. Additionally, the data presented in the Carticain CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Carticain DMF.
A Carticain CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Carticain 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 Carticain suppliers with CEP (COS) on PharmaCompass.
A Carticain written confirmation (Carticain WC) is an official document issued by a regulatory agency to a Carticain manufacturer, verifying that the manufacturing facility of a Carticain active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Carticain APIs or Carticain finished pharmaceutical products to another nation, regulatory agencies frequently require a Carticain WC (written confirmation) as part of the regulatory process.
click here to find a list of Carticain 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 Carticain as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Carticain 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 Carticain 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 Carticain and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Carticain NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Carticain suppliers with NDC on PharmaCompass.
Carticain 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 Carticain 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 Carticain GMP manufacturer or Carticain GMP API supplier for your needs.
A Carticain CoA (Certificate of Analysis) is a formal document that attests to Carticain's compliance with Carticain specifications and serves as a tool for batch-level quality control.
Carticain CoA mostly includes findings from lab analyses of a specific batch. For each Carticain 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.
Carticain may be tested according to a variety of international standards, such as European Pharmacopoeia (Carticain EP), Carticain JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Carticain USP).
