Synopsis
0
EU WC
0
KDMF
0
VMF
0
Australia
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] 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 Imports and Exports
Upgrade, download data, analyse, strategize, subscribe with us 
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]DRUG PRODUCT COMPOSITIONS
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
Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Parenteral
Controlled & Modified Release
Fillers, Diluents & Binders
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Mepivacaine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mepivacaine, including repackagers and relabelers. The FDA regulates Mepivacaine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mepivacaine 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 Mepivacaine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mepivacaine supplier is an individual or a company that provides Mepivacaine active pharmaceutical ingredient (API) or Mepivacaine finished formulations upon request. The Mepivacaine suppliers may include Mepivacaine API manufacturers, exporters, distributors and traders.
click here to find a list of Mepivacaine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mepivacaine DMF (Drug Master File) is a document detailing the whole manufacturing process of Mepivacaine active pharmaceutical ingredient (API) in detail. Different forms of Mepivacaine DMFs exist exist since differing nations have different regulations, such as Mepivacaine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mepivacaine DMF submitted to regulatory agencies in the US is known as a USDMF. Mepivacaine USDMF includes data on Mepivacaine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mepivacaine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mepivacaine 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 Mepivacaine Drug Master File in Japan (Mepivacaine JDMF) empowers Mepivacaine 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 Mepivacaine JDMF during the approval evaluation for pharmaceutical products. At the time of Mepivacaine 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 Mepivacaine suppliers with JDMF on PharmaCompass.
A Mepivacaine CEP of the European Pharmacopoeia monograph is often referred to as a Mepivacaine Certificate of Suitability (COS). The purpose of a Mepivacaine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mepivacaine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mepivacaine to their clients by showing that a Mepivacaine CEP has been issued for it. The manufacturer submits a Mepivacaine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mepivacaine CEP holder for the record. Additionally, the data presented in the Mepivacaine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mepivacaine DMF.
A Mepivacaine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mepivacaine 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 Mepivacaine 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 Mepivacaine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mepivacaine 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 Mepivacaine 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 Mepivacaine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mepivacaine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mepivacaine suppliers with NDC on PharmaCompass.
Mepivacaine 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 Mepivacaine 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 Mepivacaine GMP manufacturer or Mepivacaine GMP API supplier for your needs.
A Mepivacaine CoA (Certificate of Analysis) is a formal document that attests to Mepivacaine's compliance with Mepivacaine specifications and serves as a tool for batch-level quality control.
Mepivacaine CoA mostly includes findings from lab analyses of a specific batch. For each Mepivacaine 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.
Mepivacaine may be tested according to a variety of international standards, such as European Pharmacopoeia (Mepivacaine EP), Mepivacaine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mepivacaine USP).
LOOKING FOR A SUPPLIER?
