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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.
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USDMF
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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
About the Company : Founded in 1987, Transo-Pharm is a fully licensed and certified global distributor of pharmaceutical components for the health and veterinary industries. The company supports its c...
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
About the Company : Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists ...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
About the Company : Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 ...
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has ...
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
About the Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pilot plants, and produ...
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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 Articain manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Articain, including repackagers and relabelers. The FDA regulates Articain manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Articain 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 Articain manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Articain supplier is an individual or a company that provides Articain active pharmaceutical ingredient (API) or Articain finished formulations upon request. The Articain suppliers may include Articain API manufacturers, exporters, distributors and traders.
click here to find a list of Articain suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Articain DMF (Drug Master File) is a document detailing the whole manufacturing process of Articain active pharmaceutical ingredient (API) in detail. Different forms of Articain DMFs exist exist since differing nations have different regulations, such as Articain USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Articain DMF submitted to regulatory agencies in the US is known as a USDMF. Articain USDMF includes data on Articain's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Articain USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Articain 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 Articain Drug Master File in Japan (Articain JDMF) empowers Articain 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 Articain JDMF during the approval evaluation for pharmaceutical products. At the time of Articain 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 Articain 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 Articain Drug Master File in Korea (Articain KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Articain. The MFDS reviews the Articain KDMF as part of the drug registration process and uses the information provided in the Articain KDMF to evaluate the safety and efficacy of the drug.
After submitting a Articain 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 Articain API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Articain suppliers with KDMF on PharmaCompass.
A Articain CEP of the European Pharmacopoeia monograph is often referred to as a Articain Certificate of Suitability (COS). The purpose of a Articain CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Articain EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Articain to their clients by showing that a Articain CEP has been issued for it. The manufacturer submits a Articain CEP (COS) as part of the market authorization procedure, and it takes on the role of a Articain CEP holder for the record. Additionally, the data presented in the Articain CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Articain DMF.
A Articain CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Articain 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 Articain suppliers with CEP (COS) on PharmaCompass.
A Articain written confirmation (Articain WC) is an official document issued by a regulatory agency to a Articain manufacturer, verifying that the manufacturing facility of a Articain active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Articain APIs or Articain finished pharmaceutical products to another nation, regulatory agencies frequently require a Articain WC (written confirmation) as part of the regulatory process.
click here to find a list of Articain 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 Articain as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Articain 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 Articain 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 Articain and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Articain NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Articain suppliers with NDC on PharmaCompass.
Articain 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 Articain 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 Articain GMP manufacturer or Articain GMP API supplier for your needs.
A Articain CoA (Certificate of Analysis) is a formal document that attests to Articain's compliance with Articain specifications and serves as a tool for batch-level quality control.
Articain CoA mostly includes findings from lab analyses of a specific batch. For each Articain 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.
Articain may be tested according to a variety of international standards, such as European Pharmacopoeia (Articain EP), Articain JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Articain USP).
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