Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
US Medicaid
NA
Annual Reports
NA
Regulatory FDF Prices
NA
0
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
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36332
Submission : 2021-10-07
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
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
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
About the Company : Since 1962, MOEHS has produced high-quality Active Pharmaceutical Ingredients (APIs) for the global market. With decades of technical expertise, Moehs Group delivers pharmaceutical...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercialization. With strong expe...
ASolution Pharmaceuticals: Your CDMO Partner for APIs and Specialty Molecules.
About the Company : Established in 2010, ASolution is an India-based custom developer and manufacturer serving pharmaceutical needs across multiple scales. The company provides process development, op...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
About the Company : Supriya Lifescience Limited, established in 1987 and headquartered in Mumbai, is a globally recognized, technology-driven manufacturer of APIs, CDMO, and formulations. Its faciliti...
Enaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
About the Company : Enaltec, founded in 2006, specializes in developing and manufacturing complex, small-volume, technology-driven APIs at competitive prices, leveraging the India advantage for global...
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
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Methyl 3-((3S)-7-bromo-2-((2-hydroxypropyl)amino)-...
CAS Number : 308243-54-1
End Use API : Remimazolam Besylate
About The Company : Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercializati...
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]Digital Content
NEWS #PharmaBuzz
30 Aug 2023
// GLOBENEWSWIRE
01 May 2023
// GLOBENEWSWIRE
16 Feb 2023
// EMA
28 Jan 2021
// GLOBENEWSWIRE
15 Jul 2020
// GLOBENEWLSWIRE
02 Jul 2020
// PRESS RELEASE
Market Place
APIs
Reply
30 Dec 2024
Reply
09 Feb 2023
Reply
27 Sep 2022
Reply
03 May 2022
Reply
11 Jan 2021
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
87
PharmaCompass offers a list of Remimazolam Besylate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Remimazolam Besylate manufacturer or Remimazolam Besylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Remimazolam Besylate manufacturer or Remimazolam Besylate supplier.
A Remimazolam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Remimazolam, including repackagers and relabelers. The FDA regulates Remimazolam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Remimazolam 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 Remimazolam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Remimazolam supplier is an individual or a company that provides Remimazolam active pharmaceutical ingredient (API) or Remimazolam finished formulations upon request. The Remimazolam suppliers may include Remimazolam API manufacturers, exporters, distributors and traders.
click here to find a list of Remimazolam suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Remimazolam DMF (Drug Master File) is a document detailing the whole manufacturing process of Remimazolam active pharmaceutical ingredient (API) in detail. Different forms of Remimazolam DMFs exist exist since differing nations have different regulations, such as Remimazolam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Remimazolam DMF submitted to regulatory agencies in the US is known as a USDMF. Remimazolam USDMF includes data on Remimazolam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Remimazolam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Remimazolam suppliers with USDMF 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 Remimazolam Drug Master File in Korea (Remimazolam KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Remimazolam. The MFDS reviews the Remimazolam KDMF as part of the drug registration process and uses the information provided in the Remimazolam KDMF to evaluate the safety and efficacy of the drug.
After submitting a Remimazolam 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 Remimazolam API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Remimazolam suppliers with KDMF 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 Remimazolam as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Remimazolam 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 Remimazolam 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 Remimazolam and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Remimazolam NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Remimazolam suppliers with NDC on PharmaCompass.
Remimazolam 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 Remimazolam GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Remimazolam GMP manufacturer or Remimazolam GMP API supplier for your needs.
A Remimazolam CoA (Certificate of Analysis) is a formal document that attests to Remimazolam's compliance with Remimazolam specifications and serves as a tool for batch-level quality control.
Remimazolam CoA mostly includes findings from lab analyses of a specific batch. For each Remimazolam 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.
Remimazolam may be tested according to a variety of international standards, such as European Pharmacopoeia (Remimazolam EP), Remimazolam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Remimazolam USP).
Share 
Comment (3)
