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
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
CEP/COS 
NDC
ASMF, CA
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
EU-WC
KDMF
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
JDMF
NDC
ASMF
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
EU-WC
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
CEP/COS
NDC
KDMF
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
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]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
70
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 Ultracain manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ultracain, including repackagers and relabelers. The FDA regulates Ultracain manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ultracain 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 Ultracain manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ultracain supplier is an individual or a company that provides Ultracain active pharmaceutical ingredient (API) or Ultracain finished formulations upon request. The Ultracain suppliers may include Ultracain API manufacturers, exporters, distributors and traders.
click here to find a list of Ultracain suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ultracain DMF (Drug Master File) is a document detailing the whole manufacturing process of Ultracain active pharmaceutical ingredient (API) in detail. Different forms of Ultracain DMFs exist exist since differing nations have different regulations, such as Ultracain USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ultracain DMF submitted to regulatory agencies in the US is known as a USDMF. Ultracain USDMF includes data on Ultracain's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ultracain USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ultracain 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 Ultracain Drug Master File in Japan (Ultracain JDMF) empowers Ultracain 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 Ultracain JDMF during the approval evaluation for pharmaceutical products. At the time of Ultracain 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 Ultracain 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 Ultracain Drug Master File in Korea (Ultracain KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ultracain. The MFDS reviews the Ultracain KDMF as part of the drug registration process and uses the information provided in the Ultracain KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ultracain 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 Ultracain API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ultracain suppliers with KDMF on PharmaCompass.
A Ultracain CEP of the European Pharmacopoeia monograph is often referred to as a Ultracain Certificate of Suitability (COS). The purpose of a Ultracain CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ultracain EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ultracain to their clients by showing that a Ultracain CEP has been issued for it. The manufacturer submits a Ultracain CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ultracain CEP holder for the record. Additionally, the data presented in the Ultracain CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ultracain DMF.
A Ultracain CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ultracain 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 Ultracain suppliers with CEP (COS) on PharmaCompass.
A Ultracain written confirmation (Ultracain WC) is an official document issued by a regulatory agency to a Ultracain manufacturer, verifying that the manufacturing facility of a Ultracain active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ultracain APIs or Ultracain finished pharmaceutical products to another nation, regulatory agencies frequently require a Ultracain WC (written confirmation) as part of the regulatory process.
click here to find a list of Ultracain 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 Ultracain as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ultracain 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 Ultracain 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 Ultracain and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ultracain NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ultracain suppliers with NDC on PharmaCompass.
Ultracain 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 Ultracain 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 Ultracain GMP manufacturer or Ultracain GMP API supplier for your needs.
A Ultracain CoA (Certificate of Analysis) is a formal document that attests to Ultracain's compliance with Ultracain specifications and serves as a tool for batch-level quality control.
Ultracain CoA mostly includes findings from lab analyses of a specific batch. For each Ultracain 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.
Ultracain may be tested according to a variety of international standards, such as European Pharmacopoeia (Ultracain EP), Ultracain JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ultracain USP).
