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1. Schembl15061349
Molecular Weight | 472.9 g/mol |
---|---|
Molecular Formula | C23H32Cl3N3O |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 9 |
Exact Mass | 471.161096 g/mol |
Monoisotopic Mass | 471.161096 g/mol |
Topological Polar Surface Area | 43.2 Ų |
Heavy Atom Count | 30 |
Formal Charge | 0 |
Complexity | 461 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 1 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 3 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3905
Submission : 1980-08-08
Status : Inactive
Type : II
NDC Package Code : 73377-034
Start Marketing Date : 2020-03-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 51927-0322
Start Marketing Date : 2023-10-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 82393-307
Start Marketing Date : 2023-10-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65732-201
Start Marketing Date : 2023-07-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65732-202
Start Marketing Date : 2023-07-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Market Place
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06 Jun 2019
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01 Jun 2019
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26 Feb 2019
ABOUT THIS PAGE
A Quinacrine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Quinacrine Hydrochloride, including repackagers and relabelers. The FDA regulates Quinacrine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Quinacrine Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Quinacrine Hydrochloride supplier is an individual or a company that provides Quinacrine Hydrochloride active pharmaceutical ingredient (API) or Quinacrine Hydrochloride finished formulations upon request. The Quinacrine Hydrochloride suppliers may include Quinacrine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Quinacrine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Quinacrine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Quinacrine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Quinacrine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Quinacrine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Quinacrine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Quinacrine Hydrochloride USDMF includes data on Quinacrine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Quinacrine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Quinacrine Hydrochloride suppliers with USDMF 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 Quinacrine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Quinacrine Hydrochloride 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 Quinacrine Hydrochloride 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 Quinacrine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Quinacrine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Quinacrine Hydrochloride suppliers with NDC on PharmaCompass.
Quinacrine Hydrochloride 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 Quinacrine Hydrochloride 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 Quinacrine Hydrochloride GMP manufacturer or Quinacrine Hydrochloride GMP API supplier for your needs.
A Quinacrine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Quinacrine Hydrochloride's compliance with Quinacrine Hydrochloride specifications and serves as a tool for batch-level quality control.
Quinacrine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Quinacrine Hydrochloride 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.
Quinacrine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Quinacrine Hydrochloride EP), Quinacrine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Quinacrine Hydrochloride USP).
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