Synopsis
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EDQM
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JP
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
1. 709031-78-7
Molecular Weight | 351.9 g/mol |
---|---|
Molecular Formula | C18H26ClN3O2 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 2 |
Exact Mass | 351.1713548 g/mol |
Monoisotopic Mass | 351.1713548 g/mol |
Topological Polar Surface Area | 90.4 Ų |
Heavy Atom Count | 24 |
Formal Charge | 0 |
Complexity | 609 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 3 |
Undefined Atom Stereocenter Count | 3 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
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A KOMBIGLYZE XR-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of KOMBIGLYZE XR-1, including repackagers and relabelers. The FDA regulates KOMBIGLYZE XR-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. KOMBIGLYZE XR-1 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 KOMBIGLYZE XR-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A KOMBIGLYZE XR-1 supplier is an individual or a company that provides KOMBIGLYZE XR-1 active pharmaceutical ingredient (API) or KOMBIGLYZE XR-1 finished formulations upon request. The KOMBIGLYZE XR-1 suppliers may include KOMBIGLYZE XR-1 API manufacturers, exporters, distributors and traders.
click here to find a list of KOMBIGLYZE XR-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A KOMBIGLYZE XR-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of KOMBIGLYZE XR-1 active pharmaceutical ingredient (API) in detail. Different forms of KOMBIGLYZE XR-1 DMFs exist exist since differing nations have different regulations, such as KOMBIGLYZE XR-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A KOMBIGLYZE XR-1 DMF submitted to regulatory agencies in the US is known as a USDMF. KOMBIGLYZE XR-1 USDMF includes data on KOMBIGLYZE XR-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The KOMBIGLYZE XR-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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A KOMBIGLYZE XR-1 written confirmation (KOMBIGLYZE XR-1 WC) is an official document issued by a regulatory agency to a KOMBIGLYZE XR-1 manufacturer, verifying that the manufacturing facility of a KOMBIGLYZE XR-1 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting KOMBIGLYZE XR-1 APIs or KOMBIGLYZE XR-1 finished pharmaceutical products to another nation, regulatory agencies frequently require a KOMBIGLYZE XR-1 WC (written confirmation) as part of the regulatory process.
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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 KOMBIGLYZE XR-1 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for KOMBIGLYZE XR-1 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 KOMBIGLYZE XR-1 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 KOMBIGLYZE XR-1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a KOMBIGLYZE XR-1 NDC to their finished compounded human drug products, they may choose to do so.
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KOMBIGLYZE XR-1 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 KOMBIGLYZE XR-1 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 KOMBIGLYZE XR-1 GMP manufacturer or KOMBIGLYZE XR-1 GMP API supplier for your needs.
A KOMBIGLYZE XR-1 CoA (Certificate of Analysis) is a formal document that attests to KOMBIGLYZE XR-1's compliance with KOMBIGLYZE XR-1 specifications and serves as a tool for batch-level quality control.
KOMBIGLYZE XR-1 CoA mostly includes findings from lab analyses of a specific batch. For each KOMBIGLYZE XR-1 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.
KOMBIGLYZE XR-1 may be tested according to a variety of international standards, such as European Pharmacopoeia (KOMBIGLYZE XR-1 EP), KOMBIGLYZE XR-1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (KOMBIGLYZE XR-1 USP).