Synopsis
0
CEP/COS
0
KDMF
0
VMF
0
FDF
0
Canada
0
Australia
DRUG PRODUCT COMPOSITIONS
0
EDQM
0
USP
0
JP
0
Others
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
0
News #PharmaBuzz
US Medicaid
NA
Annual Reports
NA
Finished Drug Prices
NA
API SUPPLIERS
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
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]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 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]Market Place
ABOUT THIS PAGE
A Levobupivacaine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levobupivacaine Hydrochloride, including repackagers and relabelers. The FDA regulates Levobupivacaine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levobupivacaine 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 Levobupivacaine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levobupivacaine Hydrochloride supplier is an individual or a company that provides Levobupivacaine Hydrochloride active pharmaceutical ingredient (API) or Levobupivacaine Hydrochloride finished formulations upon request. The Levobupivacaine Hydrochloride suppliers may include Levobupivacaine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Levobupivacaine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levobupivacaine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Levobupivacaine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Levobupivacaine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Levobupivacaine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levobupivacaine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Levobupivacaine Hydrochloride USDMF includes data on Levobupivacaine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levobupivacaine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levobupivacaine 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 Levobupivacaine Hydrochloride Drug Master File in Japan (Levobupivacaine Hydrochloride JDMF) empowers Levobupivacaine 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 Levobupivacaine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Levobupivacaine 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 Levobupivacaine Hydrochloride suppliers with JDMF on PharmaCompass.
A Levobupivacaine Hydrochloride written confirmation (Levobupivacaine Hydrochloride WC) is an official document issued by a regulatory agency to a Levobupivacaine Hydrochloride manufacturer, verifying that the manufacturing facility of a Levobupivacaine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Levobupivacaine Hydrochloride APIs or Levobupivacaine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Levobupivacaine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Levobupivacaine Hydrochloride 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 Levobupivacaine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Levobupivacaine 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 Levobupivacaine 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 Levobupivacaine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Levobupivacaine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Levobupivacaine Hydrochloride suppliers with NDC on PharmaCompass.
Levobupivacaine 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 Levobupivacaine 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 Levobupivacaine Hydrochloride GMP manufacturer or Levobupivacaine Hydrochloride GMP API supplier for your needs.
A Levobupivacaine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Levobupivacaine Hydrochloride's compliance with Levobupivacaine Hydrochloride specifications and serves as a tool for batch-level quality control.
Levobupivacaine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Levobupivacaine 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.
Levobupivacaine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Levobupivacaine Hydrochloride EP), Levobupivacaine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Levobupivacaine Hydrochloride USP).
LOOKING FOR A SUPPLIER?
