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USDMF
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Aspen API. More than just an API.
Certificate Number : R1-CEP 2009-231 - Rev 02
Status : Valid
Issue Date : 2022-11-25
Type : Chemical
Substance Number : 1764
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
Rocuronium Bromide, Process II
Certificate Number : CEP 2023-131 - Rev 01
Status : Valid
Issue Date : 2024-06-03
Type : Chemical
Substance Number : 1764
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
Certificate Number : R1-CEP 2006-176 - Rev 02
Status : Valid
Issue Date : 2022-08-23
Type : Chemical
Substance Number : 1764
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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- INJECTABLE;INJECTION - 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- INJECTABLE;INJECTION - 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- INJECTABLE;INJECTION - 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
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ABOUT THIS PAGE
A Rocuronium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rocuronium, including repackagers and relabelers. The FDA regulates Rocuronium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rocuronium 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 Rocuronium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rocuronium supplier is an individual or a company that provides Rocuronium active pharmaceutical ingredient (API) or Rocuronium finished formulations upon request. The Rocuronium suppliers may include Rocuronium API manufacturers, exporters, distributors and traders.
click here to find a list of Rocuronium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rocuronium DMF (Drug Master File) is a document detailing the whole manufacturing process of Rocuronium active pharmaceutical ingredient (API) in detail. Different forms of Rocuronium DMFs exist exist since differing nations have different regulations, such as Rocuronium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rocuronium DMF submitted to regulatory agencies in the US is known as a USDMF. Rocuronium USDMF includes data on Rocuronium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rocuronium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rocuronium 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 Rocuronium Drug Master File in Japan (Rocuronium JDMF) empowers Rocuronium 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 Rocuronium JDMF during the approval evaluation for pharmaceutical products. At the time of Rocuronium 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 Rocuronium 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 Rocuronium Drug Master File in Korea (Rocuronium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rocuronium. The MFDS reviews the Rocuronium KDMF as part of the drug registration process and uses the information provided in the Rocuronium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rocuronium 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 Rocuronium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rocuronium suppliers with KDMF on PharmaCompass.
A Rocuronium CEP of the European Pharmacopoeia monograph is often referred to as a Rocuronium Certificate of Suitability (COS). The purpose of a Rocuronium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rocuronium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rocuronium to their clients by showing that a Rocuronium CEP has been issued for it. The manufacturer submits a Rocuronium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rocuronium CEP holder for the record. Additionally, the data presented in the Rocuronium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rocuronium DMF.
A Rocuronium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rocuronium 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 Rocuronium suppliers with CEP (COS) on PharmaCompass.
A Rocuronium written confirmation (Rocuronium WC) is an official document issued by a regulatory agency to a Rocuronium manufacturer, verifying that the manufacturing facility of a Rocuronium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rocuronium APIs or Rocuronium finished pharmaceutical products to another nation, regulatory agencies frequently require a Rocuronium WC (written confirmation) as part of the regulatory process.
click here to find a list of Rocuronium 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 Rocuronium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rocuronium 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 Rocuronium 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 Rocuronium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rocuronium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rocuronium suppliers with NDC on PharmaCompass.
Rocuronium 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 Rocuronium 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 Rocuronium GMP manufacturer or Rocuronium GMP API supplier for your needs.
A Rocuronium CoA (Certificate of Analysis) is a formal document that attests to Rocuronium's compliance with Rocuronium specifications and serves as a tool for batch-level quality control.
Rocuronium CoA mostly includes findings from lab analyses of a specific batch. For each Rocuronium 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.
Rocuronium may be tested according to a variety of international standards, such as European Pharmacopoeia (Rocuronium EP), Rocuronium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rocuronium USP).
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