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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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Moehs Group, a reference company in the production of pharmaceutical active ingredients.
About the Company : Since 1962, MOEHS has produced high-quality Active Pharmaceutical Ingredients (APIs) for the global market. With decades of technical expertise, Moehs Group delivers pharmaceutical...
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. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer of Finished Formulat...
Together we can improve the quality of life
About the Company : Shamrock Pharmachemi Pvt Ltd. is a globally recognized API leader with 26+ years in human and veterinary pharmaceuticals. Operating in 40+ countries, it owns two Gujarat facilities...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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Regulatory Info : Approved
Registration Country : Sweden
Adrenaline Tartrate; Mepivacaine Hydrochloride
Brand Name : Carbocain Adrenaline
Dosage Form : Injectable Solution
Dosage Strength : 10mg/ml;5mcg/ml
Packaging :
Approval Date : 1959-10-13
Application Number : 19591013000050
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Adrenaline Tartrate; Mepivacaine Hydrochloride
Brand Name : Carbocain Adrenaline
Dosage Form : Injectable Solution
Dosage Strength : 20mg/ml;5mcg/ml
Packaging :
Approval Date : 1959-10-13
Application Number : 19591013000067
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Adrenaline Tartrate; Mepivacaine Hydrochloride
Brand Name : Carbocain Adrenaline
Dosage Form : Injectable Solution
Dosage Strength : 5mg/ml;5mcg/ml
Packaging :
Approval Date : 1959-10-13
Application Number : 19591013000043
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Carbocain
Dosage Form : Injectable Solution
Dosage Strength : 10mg/ml
Packaging :
Approval Date : 13/10/1959
Application Number : 19591013000029
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Carbocain
Dosage Form : Injectable Solution
Dosage Strength : 20mg/ml
Packaging :
Approval Date : 13/10/1959
Application Number : 19591013000036
Regulatory Info : Approved
Registration Country : Sweden
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DOSAGE - INJECTABLE;INJECTION - 1%
USFDA APPLICATION NUMBER - 12250
DOSAGE - INJECTABLE;INJECTION - 1.5%
USFDA APPLICATION NUMBER - 12250
DOSAGE - INJECTABLE;INJECTION - 2%
USFDA APPLICATION NUMBER - 12250
Related Excipient Companies
Kirsch Pharma
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Controlled & Modified Release
Fillers, Diluents & Binders
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REF. STANDARDS & IMPURITIES
Others
Sigma-Aldrich empowers scientific discovery with top-quality solutions to accelerate research, innovation, and better health worldwide.
CAS Number : 1722-62-9
Quantity Per Vial :
Sale Unit :
Price : $248.00
Details :
Monograph : PHR1955-500MG
Storage : +2°C to +30°C
Code/Batch No :
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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PharmaCompass offers a list of Mepivacaine 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 Mepivacaine Hydrochloride manufacturer or Mepivacaine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mepivacaine Hydrochloride manufacturer or Mepivacaine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Mepivacaine Hydrochloride API Price utilized in the formulation of products. Mepivacaine Hydrochloride API Price is not always fixed or binding as the Mepivacaine Hydrochloride Price is obtained through a variety of data sources. The Mepivacaine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Scandicaine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Scandicaine, including repackagers and relabelers. The FDA regulates Scandicaine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Scandicaine 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 Scandicaine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Scandicaine supplier is an individual or a company that provides Scandicaine active pharmaceutical ingredient (API) or Scandicaine finished formulations upon request. The Scandicaine suppliers may include Scandicaine API manufacturers, exporters, distributors and traders.
click here to find a list of Scandicaine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Scandicaine DMF (Drug Master File) is a document detailing the whole manufacturing process of Scandicaine active pharmaceutical ingredient (API) in detail. Different forms of Scandicaine DMFs exist exist since differing nations have different regulations, such as Scandicaine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Scandicaine DMF submitted to regulatory agencies in the US is known as a USDMF. Scandicaine USDMF includes data on Scandicaine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Scandicaine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Scandicaine 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 Scandicaine Drug Master File in Japan (Scandicaine JDMF) empowers Scandicaine 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 Scandicaine JDMF during the approval evaluation for pharmaceutical products. At the time of Scandicaine 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 Scandicaine suppliers with JDMF on PharmaCompass.
A Scandicaine CEP of the European Pharmacopoeia monograph is often referred to as a Scandicaine Certificate of Suitability (COS). The purpose of a Scandicaine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Scandicaine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Scandicaine to their clients by showing that a Scandicaine CEP has been issued for it. The manufacturer submits a Scandicaine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Scandicaine CEP holder for the record. Additionally, the data presented in the Scandicaine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Scandicaine DMF.
A Scandicaine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Scandicaine 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 Scandicaine suppliers with CEP (COS) 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 Scandicaine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Scandicaine 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 Scandicaine 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 Scandicaine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Scandicaine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Scandicaine suppliers with NDC on PharmaCompass.
Scandicaine 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 Scandicaine 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 Scandicaine GMP manufacturer or Scandicaine GMP API supplier for your needs.
A Scandicaine CoA (Certificate of Analysis) is a formal document that attests to Scandicaine's compliance with Scandicaine specifications and serves as a tool for batch-level quality control.
Scandicaine CoA mostly includes findings from lab analyses of a specific batch. For each Scandicaine 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.
Scandicaine may be tested according to a variety of international standards, such as European Pharmacopoeia (Scandicaine EP), Scandicaine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Scandicaine USP).
