Synopsis
Synopsis
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CEP/COS
0
JDMF
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EU WC
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VMF
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EDQM
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USP
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JP
0
Others
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Canada
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Australia
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South Africa
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Listed Dossiers
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API
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FDF
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
Molecular Weight | 473.4 g/mol |
---|---|
Molecular Formula | C20H23N7O7 |
XLogP3 | -1.2 |
Hydrogen Bond Donor Count | 7 |
Hydrogen Bond Acceptor Count | 9 |
Rotatable Bond Count | 9 |
Exact Mass | 473.16589610 g/mol |
Monoisotopic Mass | 473.16589610 g/mol |
Topological Polar Surface Area | 216 A^2 |
Heavy Atom Count | 34 |
Formal Charge | 0 |
Complexity | 911 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30495
Submission : 2016-06-07
Status : Active
Type : II
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Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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PharmaCompass offers a list of Levoleucovorin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Levoleucovorin manufacturer or Levoleucovorin supplier for your needs.
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PharmaCompass also assists you with knowing the Levoleucovorin API Price utilized in the formulation of products. Levoleucovorin API Price is not always fixed or binding as the Levoleucovorin Price is obtained through a variety of data sources. The Levoleucovorin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A L-Folinic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Folinic acid, including repackagers and relabelers. The FDA regulates L-Folinic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Folinic acid 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 L-Folinic acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Folinic acid supplier is an individual or a company that provides L-Folinic acid active pharmaceutical ingredient (API) or L-Folinic acid finished formulations upon request. The L-Folinic acid suppliers may include L-Folinic acid API manufacturers, exporters, distributors and traders.
click here to find a list of L-Folinic acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Folinic acid DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Folinic acid active pharmaceutical ingredient (API) in detail. Different forms of L-Folinic acid DMFs exist exist since differing nations have different regulations, such as L-Folinic acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Folinic acid DMF submitted to regulatory agencies in the US is known as a USDMF. L-Folinic acid USDMF includes data on L-Folinic acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Folinic acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Folinic acid 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 L-Folinic acid Drug Master File in Korea (L-Folinic acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of L-Folinic acid. The MFDS reviews the L-Folinic acid KDMF as part of the drug registration process and uses the information provided in the L-Folinic acid KDMF to evaluate the safety and efficacy of the drug.
After submitting a L-Folinic acid 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 L-Folinic acid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of L-Folinic acid 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 L-Folinic acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for L-Folinic acid 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 L-Folinic acid 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 L-Folinic acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a L-Folinic acid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of L-Folinic acid suppliers with NDC on PharmaCompass.
L-Folinic acid 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 L-Folinic acid 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 L-Folinic acid GMP manufacturer or L-Folinic acid GMP API supplier for your needs.
A L-Folinic acid CoA (Certificate of Analysis) is a formal document that attests to L-Folinic acid's compliance with L-Folinic acid specifications and serves as a tool for batch-level quality control.
L-Folinic acid CoA mostly includes findings from lab analyses of a specific batch. For each L-Folinic acid 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.
L-Folinic acid may be tested according to a variety of international standards, such as European Pharmacopoeia (L-Folinic acid EP), L-Folinic acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (L-Folinic acid USP).