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KDMF
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DRUG PRODUCT COMPOSITIONS0
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Basic Nutrition, your expert for sourcing from China, India and Europe.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Maithri Drugs: Delivering Trusted, High-Quality APIs to 35+ Countries with Innovation, Compliance, and Excellence.
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USDMF
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
Lead Product(s) : Sarilumab,Methotrexate,Folic Acid
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Regeneron Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Antibody
Upfront Cash : Inapplicable
November 19, 2014
Lead Product(s) : Sarilumab,Methotrexate,Folic Acid
Therapeutic Area : Immunology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Regeneron Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Antibody
Upfront Cash : Inapplicable
May 09, 2013
Lead Product(s) : Sarilumab,Methotrexate,Folic Acid
Therapeutic Area : Immunology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Regeneron Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients
Details : Undisclosed
Product Name : Undisclosed
Product Type : Antibody
Upfront Cash : Inapplicable
February 03, 2010
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DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL...DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL
USFDA APPLICATION NUMBER - 18920
DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/...DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML
USFDA APPLICATION NUMBER - 21163
DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/...DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML
USFDA APPLICATION NUMBER - 21163
DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;...DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL
USFDA APPLICATION NUMBER - 21625
DOSAGE - INJECTABLE;INJECTION - 20MG/ML;0.006...DOSAGE - INJECTABLE;INJECTION - 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML
USFDA APPLICATION NUMBER - 8809
Related Excipient Companies
EUROAPI
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REF. STANDARDS & IMPURITIES
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
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PharmaCompass offers a list of Folic Acid 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 Folic Acid manufacturer or Folic Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Folic Acid manufacturer or Folic Acid supplier.
PharmaCompass also assists you with knowing the Folic Acid API Price utilized in the formulation of products. Folic Acid API Price is not always fixed or binding as the Folic Acid Price is obtained through a variety of data sources. The Folic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Acfol (Spain) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acfol (Spain), including repackagers and relabelers. The FDA regulates Acfol (Spain) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acfol (Spain) 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 Acfol (Spain) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Acfol (Spain) supplier is an individual or a company that provides Acfol (Spain) active pharmaceutical ingredient (API) or Acfol (Spain) finished formulations upon request. The Acfol (Spain) suppliers may include Acfol (Spain) API manufacturers, exporters, distributors and traders.
click here to find a list of Acfol (Spain) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Acfol (Spain) DMF (Drug Master File) is a document detailing the whole manufacturing process of Acfol (Spain) active pharmaceutical ingredient (API) in detail. Different forms of Acfol (Spain) DMFs exist exist since differing nations have different regulations, such as Acfol (Spain) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acfol (Spain) DMF submitted to regulatory agencies in the US is known as a USDMF. Acfol (Spain) USDMF includes data on Acfol (Spain)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acfol (Spain) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Acfol (Spain) 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 Acfol (Spain) Drug Master File in Japan (Acfol (Spain) JDMF) empowers Acfol (Spain) 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 Acfol (Spain) JDMF during the approval evaluation for pharmaceutical products. At the time of Acfol (Spain) 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 Acfol (Spain) suppliers with JDMF on PharmaCompass.
A Acfol (Spain) CEP of the European Pharmacopoeia monograph is often referred to as a Acfol (Spain) Certificate of Suitability (COS). The purpose of a Acfol (Spain) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Acfol (Spain) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Acfol (Spain) to their clients by showing that a Acfol (Spain) CEP has been issued for it. The manufacturer submits a Acfol (Spain) CEP (COS) as part of the market authorization procedure, and it takes on the role of a Acfol (Spain) CEP holder for the record. Additionally, the data presented in the Acfol (Spain) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Acfol (Spain) DMF.
A Acfol (Spain) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Acfol (Spain) 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 Acfol (Spain) suppliers with CEP (COS) on PharmaCompass.
A Acfol (Spain) written confirmation (Acfol (Spain) WC) is an official document issued by a regulatory agency to a Acfol (Spain) manufacturer, verifying that the manufacturing facility of a Acfol (Spain) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Acfol (Spain) APIs or Acfol (Spain) finished pharmaceutical products to another nation, regulatory agencies frequently require a Acfol (Spain) WC (written confirmation) as part of the regulatory process.
click here to find a list of Acfol (Spain) suppliers with Written Confirmation (WC) 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 Acfol (Spain) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Acfol (Spain) 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 Acfol (Spain) 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 Acfol (Spain) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Acfol (Spain) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Acfol (Spain) suppliers with NDC on PharmaCompass.
Acfol (Spain) 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 Acfol (Spain) 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 Acfol (Spain) GMP manufacturer or Acfol (Spain) GMP API supplier for your needs.
A Acfol (Spain) CoA (Certificate of Analysis) is a formal document that attests to Acfol (Spain)'s compliance with Acfol (Spain) specifications and serves as a tool for batch-level quality control.
Acfol (Spain) CoA mostly includes findings from lab analyses of a specific batch. For each Acfol (Spain) 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.
Acfol (Spain) may be tested according to a variety of international standards, such as European Pharmacopoeia (Acfol (Spain) EP), Acfol (Spain) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Acfol (Spain) USP).
