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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.
Maithri Drugs: Dedicated to your API needs.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
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USDMF
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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
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ABOUT THIS PAGE
21
PharmaCompass offers a list of Folic Acid API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.
A Acido folico [INN-Spanish] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acido folico [INN-Spanish], including repackagers and relabelers. The FDA regulates Acido folico [INN-Spanish] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acido folico [INN-Spanish] 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 Acido folico [INN-Spanish] manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Acido folico [INN-Spanish] supplier is an individual or a company that provides Acido folico [INN-Spanish] active pharmaceutical ingredient (API) or Acido folico [INN-Spanish] finished formulations upon request. The Acido folico [INN-Spanish] suppliers may include Acido folico [INN-Spanish] API manufacturers, exporters, distributors and traders.
click here to find a list of Acido folico [INN-Spanish] suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Acido folico [INN-Spanish] DMF (Drug Master File) is a document detailing the whole manufacturing process of Acido folico [INN-Spanish] active pharmaceutical ingredient (API) in detail. Different forms of Acido folico [INN-Spanish] DMFs exist exist since differing nations have different regulations, such as Acido folico [INN-Spanish] USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acido folico [INN-Spanish] DMF submitted to regulatory agencies in the US is known as a USDMF. Acido folico [INN-Spanish] USDMF includes data on Acido folico [INN-Spanish]'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acido folico [INN-Spanish] USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Acido folico [INN-Spanish] 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 Acido folico [INN-Spanish] Drug Master File in Japan (Acido folico [INN-Spanish] JDMF) empowers Acido folico [INN-Spanish] 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 Acido folico [INN-Spanish] JDMF during the approval evaluation for pharmaceutical products. At the time of Acido folico [INN-Spanish] 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 Acido folico [INN-Spanish] suppliers with JDMF on PharmaCompass.
A Acido folico [INN-Spanish] CEP of the European Pharmacopoeia monograph is often referred to as a Acido folico [INN-Spanish] Certificate of Suitability (COS). The purpose of a Acido folico [INN-Spanish] CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Acido folico [INN-Spanish] EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Acido folico [INN-Spanish] to their clients by showing that a Acido folico [INN-Spanish] CEP has been issued for it. The manufacturer submits a Acido folico [INN-Spanish] CEP (COS) as part of the market authorization procedure, and it takes on the role of a Acido folico [INN-Spanish] CEP holder for the record. Additionally, the data presented in the Acido folico [INN-Spanish] CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Acido folico [INN-Spanish] DMF.
A Acido folico [INN-Spanish] CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Acido folico [INN-Spanish] 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 Acido folico [INN-Spanish] suppliers with CEP (COS) on PharmaCompass.
A Acido folico [INN-Spanish] written confirmation (Acido folico [INN-Spanish] WC) is an official document issued by a regulatory agency to a Acido folico [INN-Spanish] manufacturer, verifying that the manufacturing facility of a Acido folico [INN-Spanish] active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Acido folico [INN-Spanish] APIs or Acido folico [INN-Spanish] finished pharmaceutical products to another nation, regulatory agencies frequently require a Acido folico [INN-Spanish] WC (written confirmation) as part of the regulatory process.
click here to find a list of Acido folico [INN-Spanish] 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 Acido folico [INN-Spanish] as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Acido folico [INN-Spanish] 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 Acido folico [INN-Spanish] 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 Acido folico [INN-Spanish] and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Acido folico [INN-Spanish] NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Acido folico [INN-Spanish] suppliers with NDC on PharmaCompass.
Acido folico [INN-Spanish] 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 Acido folico [INN-Spanish] GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Acido folico [INN-Spanish] GMP manufacturer or Acido folico [INN-Spanish] GMP API supplier for your needs.
A Acido folico [INN-Spanish] CoA (Certificate of Analysis) is a formal document that attests to Acido folico [INN-Spanish]'s compliance with Acido folico [INN-Spanish] specifications and serves as a tool for batch-level quality control.
Acido folico [INN-Spanish] CoA mostly includes findings from lab analyses of a specific batch. For each Acido folico [INN-Spanish] 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.
Acido folico [INN-Spanish] may be tested according to a variety of international standards, such as European Pharmacopoeia (Acido folico [INN-Spanish] EP), Acido folico [INN-Spanish] JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Acido folico [INN-Spanish] USP).
