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 Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mepivacaine Hydrochloride, including repackagers and relabelers. The FDA regulates Mepivacaine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mepivacaine Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mepivacaine Hydrochloride supplier is an individual or a company that provides Mepivacaine Hydrochloride active pharmaceutical ingredient (API) or Mepivacaine Hydrochloride finished formulations upon request. The Mepivacaine Hydrochloride suppliers may include Mepivacaine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Mepivacaine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mepivacaine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Mepivacaine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Mepivacaine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Mepivacaine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mepivacaine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Mepivacaine Hydrochloride USDMF includes data on Mepivacaine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mepivacaine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mepivacaine Hydrochloride 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 Hydrochloride Drug Master File in Japan (Mepivacaine Hydrochloride JDMF) empowers Mepivacaine Hydrochloride 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 Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Mepivacaine Hydrochloride 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 Hydrochloride suppliers with JDMF on PharmaCompass.
A Mepivacaine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Mepivacaine Hydrochloride Certificate of Suitability (COS). The purpose of a Mepivacaine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mepivacaine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mepivacaine Hydrochloride to their clients by showing that a Mepivacaine Hydrochloride CEP has been issued for it. The manufacturer submits a Mepivacaine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mepivacaine Hydrochloride CEP holder for the record. Additionally, the data presented in the Mepivacaine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mepivacaine Hydrochloride DMF.
A Mepivacaine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mepivacaine Hydrochloride 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 Hydrochloride 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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mepivacaine Hydrochloride 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 Hydrochloride 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 Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mepivacaine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mepivacaine Hydrochloride suppliers with NDC on PharmaCompass.
Mepivacaine Hydrochloride 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 Hydrochloride 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 Hydrochloride GMP manufacturer or Mepivacaine Hydrochloride GMP API supplier for your needs.
A Mepivacaine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Mepivacaine Hydrochloride's compliance with Mepivacaine Hydrochloride specifications and serves as a tool for batch-level quality control.
Mepivacaine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Mepivacaine Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Mepivacaine Hydrochloride EP), Mepivacaine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mepivacaine Hydrochloride USP).
LOOKING FOR A SUPPLIER?
