Synopsis
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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 - 100MG/10ML (1...DOSAGE - INJECTABLE;INJECTION - 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20214
DOSAGE - INJECTABLE;INJECTION - 10MG/ML (10MG...DOSAGE - INJECTABLE;INJECTION - 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20214
DOSAGE - INJECTABLE;INJECTION - 50MG/5ML (10M...DOSAGE - INJECTABLE;INJECTION - 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20214
Related Excipient Companies
Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
12
PharmaCompass offers a list of Rocuronium Bromide 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 Rocuronium Bromide manufacturer or Rocuronium Bromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rocuronium Bromide manufacturer or Rocuronium Bromide supplier.
PharmaCompass also assists you with knowing the Rocuronium Bromide API Price utilized in the formulation of products. Rocuronium Bromide API Price is not always fixed or binding as the Rocuronium Bromide Price is obtained through a variety of data sources. The Rocuronium Bromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Esmeron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Esmeron, including repackagers and relabelers. The FDA regulates Esmeron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Esmeron 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 Esmeron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Esmeron supplier is an individual or a company that provides Esmeron active pharmaceutical ingredient (API) or Esmeron finished formulations upon request. The Esmeron suppliers may include Esmeron API manufacturers, exporters, distributors and traders.
click here to find a list of Esmeron suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Esmeron DMF (Drug Master File) is a document detailing the whole manufacturing process of Esmeron active pharmaceutical ingredient (API) in detail. Different forms of Esmeron DMFs exist exist since differing nations have different regulations, such as Esmeron USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Esmeron DMF submitted to regulatory agencies in the US is known as a USDMF. Esmeron USDMF includes data on Esmeron's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Esmeron USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Esmeron 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 Esmeron Drug Master File in Japan (Esmeron JDMF) empowers Esmeron 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 Esmeron JDMF during the approval evaluation for pharmaceutical products. At the time of Esmeron 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 Esmeron 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 Esmeron Drug Master File in Korea (Esmeron KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Esmeron. The MFDS reviews the Esmeron KDMF as part of the drug registration process and uses the information provided in the Esmeron KDMF to evaluate the safety and efficacy of the drug.
After submitting a Esmeron 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 Esmeron API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Esmeron suppliers with KDMF on PharmaCompass.
A Esmeron CEP of the European Pharmacopoeia monograph is often referred to as a Esmeron Certificate of Suitability (COS). The purpose of a Esmeron CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Esmeron EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Esmeron to their clients by showing that a Esmeron CEP has been issued for it. The manufacturer submits a Esmeron CEP (COS) as part of the market authorization procedure, and it takes on the role of a Esmeron CEP holder for the record. Additionally, the data presented in the Esmeron CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Esmeron DMF.
A Esmeron CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Esmeron 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 Esmeron suppliers with CEP (COS) on PharmaCompass.
A Esmeron written confirmation (Esmeron WC) is an official document issued by a regulatory agency to a Esmeron manufacturer, verifying that the manufacturing facility of a Esmeron active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Esmeron APIs or Esmeron finished pharmaceutical products to another nation, regulatory agencies frequently require a Esmeron WC (written confirmation) as part of the regulatory process.
click here to find a list of Esmeron 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 Esmeron as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Esmeron 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 Esmeron 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 Esmeron and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Esmeron NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Esmeron suppliers with NDC on PharmaCompass.
Esmeron 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 Esmeron 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 Esmeron GMP manufacturer or Esmeron GMP API supplier for your needs.
A Esmeron CoA (Certificate of Analysis) is a formal document that attests to Esmeron's compliance with Esmeron specifications and serves as a tool for batch-level quality control.
Esmeron CoA mostly includes findings from lab analyses of a specific batch. For each Esmeron 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.
Esmeron may be tested according to a variety of international standards, such as European Pharmacopoeia (Esmeron EP), Esmeron JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Esmeron USP).
