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With Fermion, start the journey of your innovative API.
9,10-Dehydro Folitixorin Chloride
CAS Number : 804563-04-0
End Use API : Calcium Folinate
About The Company : Fermion, a wholly owned subsidiary of Orion Corporation and headquartered in Espoo, Finland, is a fully integrated CDMO offering API and formulation services. I...
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SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Taste Masking
Excipient Details : Advantose® FS95 is spray-dried fructose coprocessed with starch, is a highly compressible pharmaceutical excipient with chewable vitamin applications.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Direct Compression, Taste Masking
Excipient Details : MS90 is a directly compressible magnesium hydroxide with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-170 µm, Tapped Density: 0.80
Ingredient(s) : Magnesium Hydroxide Excipient
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175 µm, Tapped Density: 0.85
Ingredient(s) : Calcium Carbonate Excipient
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PharmaCompass offers a list of Calcium Folinate 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 Calcium Folinate manufacturer or Calcium Folinate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Calcium Folinate manufacturer or Calcium Folinate supplier.
PharmaCompass also assists you with knowing the Calcium Folinate API Price utilized in the formulation of products. Calcium Folinate API Price is not always fixed or binding as the Calcium Folinate Price is obtained through a variety of data sources. The Calcium Folinate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Leucovorin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Leucovorin, including repackagers and relabelers. The FDA regulates Leucovorin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Leucovorin 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 Leucovorin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Leucovorin supplier is an individual or a company that provides Leucovorin active pharmaceutical ingredient (API) or Leucovorin finished formulations upon request. The Leucovorin suppliers may include Leucovorin API manufacturers, exporters, distributors and traders.
click here to find a list of Leucovorin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Leucovorin DMF (Drug Master File) is a document detailing the whole manufacturing process of Leucovorin active pharmaceutical ingredient (API) in detail. Different forms of Leucovorin DMFs exist exist since differing nations have different regulations, such as Leucovorin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Leucovorin DMF submitted to regulatory agencies in the US is known as a USDMF. Leucovorin USDMF includes data on Leucovorin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Leucovorin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Leucovorin suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Leucovorin Drug Master File in Japan (Leucovorin JDMF) empowers Leucovorin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Leucovorin JDMF during the approval evaluation for pharmaceutical products. At the time of Leucovorin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Leucovorin suppliers with JDMF 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 Leucovorin Drug Master File in Korea (Leucovorin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Leucovorin. The MFDS reviews the Leucovorin KDMF as part of the drug registration process and uses the information provided in the Leucovorin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Leucovorin 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 Leucovorin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Leucovorin suppliers with KDMF on PharmaCompass.
A Leucovorin CEP of the European Pharmacopoeia monograph is often referred to as a Leucovorin Certificate of Suitability (COS). The purpose of a Leucovorin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Leucovorin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Leucovorin to their clients by showing that a Leucovorin CEP has been issued for it. The manufacturer submits a Leucovorin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Leucovorin CEP holder for the record. Additionally, the data presented in the Leucovorin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Leucovorin DMF.
A Leucovorin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Leucovorin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Leucovorin suppliers with CEP (COS) on PharmaCompass.
A Leucovorin written confirmation (Leucovorin WC) is an official document issued by a regulatory agency to a Leucovorin manufacturer, verifying that the manufacturing facility of a Leucovorin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Leucovorin APIs or Leucovorin finished pharmaceutical products to another nation, regulatory agencies frequently require a Leucovorin WC (written confirmation) as part of the regulatory process.
click here to find a list of Leucovorin suppliers with Written Confirmation (WC) on PharmaCompass.
Leucovorin 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 Leucovorin 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 Leucovorin GMP manufacturer or Leucovorin GMP API supplier for your needs.
A Leucovorin CoA (Certificate of Analysis) is a formal document that attests to Leucovorin's compliance with Leucovorin specifications and serves as a tool for batch-level quality control.
Leucovorin CoA mostly includes findings from lab analyses of a specific batch. For each Leucovorin 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.
Leucovorin may be tested according to a variety of international standards, such as European Pharmacopoeia (Leucovorin EP), Leucovorin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Leucovorin USP).
