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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, offering products and services across all phases of a molecule’s lifecycle from development to commer...
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A Remimazolam Besylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Remimazolam Besylate, including repackagers and relabelers. The FDA regulates Remimazolam Besylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Remimazolam Besylate 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 Besylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Remimazolam Besylate supplier is an individual or a company that provides Remimazolam Besylate active pharmaceutical ingredient (API) or Remimazolam Besylate finished formulations upon request. The Remimazolam Besylate suppliers may include Remimazolam Besylate API manufacturers, exporters, distributors and traders.
click here to find a list of Remimazolam Besylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Remimazolam Besylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Remimazolam Besylate active pharmaceutical ingredient (API) in detail. Different forms of Remimazolam Besylate DMFs exist exist since differing nations have different regulations, such as Remimazolam Besylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Remimazolam Besylate DMF submitted to regulatory agencies in the US is known as a USDMF. Remimazolam Besylate USDMF includes data on Remimazolam Besylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Remimazolam Besylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Remimazolam Besylate 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 Besylate Drug Master File in Korea (Remimazolam Besylate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Remimazolam Besylate. The MFDS reviews the Remimazolam Besylate KDMF as part of the drug registration process and uses the information provided in the Remimazolam Besylate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Remimazolam Besylate 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 Besylate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Remimazolam Besylate 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 Besylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Remimazolam Besylate 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 Besylate 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 Besylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Remimazolam Besylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Remimazolam Besylate suppliers with NDC on PharmaCompass.
Remimazolam Besylate 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 Besylate 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 Remimazolam Besylate GMP manufacturer or Remimazolam Besylate GMP API supplier for your needs.
A Remimazolam Besylate CoA (Certificate of Analysis) is a formal document that attests to Remimazolam Besylate's compliance with Remimazolam Besylate specifications and serves as a tool for batch-level quality control.
Remimazolam Besylate CoA mostly includes findings from lab analyses of a specific batch. For each Remimazolam Besylate 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 Besylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Remimazolam Besylate EP), Remimazolam Besylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Remimazolam Besylate USP).
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