API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
0
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
32
PharmaCompass offers a list of Mefloquine 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 Mefloquine manufacturer or Mefloquine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mefloquine manufacturer or Mefloquine supplier.
PharmaCompass also assists you with knowing the Mefloquine API Price utilized in the formulation of products. Mefloquine API Price is not always fixed or binding as the Mefloquine Price is obtained through a variety of data sources. The Mefloquine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A (+/-)-MEFLOQUINE HCL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (+/-)-MEFLOQUINE HCL, including repackagers and relabelers. The FDA regulates (+/-)-MEFLOQUINE HCL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (+/-)-MEFLOQUINE HCL 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 (+/-)-MEFLOQUINE HCL manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (+/-)-MEFLOQUINE HCL supplier is an individual or a company that provides (+/-)-MEFLOQUINE HCL active pharmaceutical ingredient (API) or (+/-)-MEFLOQUINE HCL finished formulations upon request. The (+/-)-MEFLOQUINE HCL suppliers may include (+/-)-MEFLOQUINE HCL API manufacturers, exporters, distributors and traders.
click here to find a list of (+/-)-MEFLOQUINE HCL suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A (+/-)-MEFLOQUINE HCL DMF (Drug Master File) is a document detailing the whole manufacturing process of (+/-)-MEFLOQUINE HCL active pharmaceutical ingredient (API) in detail. Different forms of (+/-)-MEFLOQUINE HCL DMFs exist exist since differing nations have different regulations, such as (+/-)-MEFLOQUINE HCL USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (+/-)-MEFLOQUINE HCL DMF submitted to regulatory agencies in the US is known as a USDMF. (+/-)-MEFLOQUINE HCL USDMF includes data on (+/-)-MEFLOQUINE HCL's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (+/-)-MEFLOQUINE HCL USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of (+/-)-MEFLOQUINE HCL 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 (+/-)-MEFLOQUINE HCL Drug Master File in Korea ((+/-)-MEFLOQUINE HCL KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of (+/-)-MEFLOQUINE HCL. The MFDS reviews the (+/-)-MEFLOQUINE HCL KDMF as part of the drug registration process and uses the information provided in the (+/-)-MEFLOQUINE HCL KDMF to evaluate the safety and efficacy of the drug.
After submitting a (+/-)-MEFLOQUINE HCL 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 (+/-)-MEFLOQUINE HCL API can apply through the Korea Drug Master File (KDMF).
click here to find a list of (+/-)-MEFLOQUINE HCL suppliers with KDMF on PharmaCompass.
A (+/-)-MEFLOQUINE HCL CEP of the European Pharmacopoeia monograph is often referred to as a (+/-)-MEFLOQUINE HCL Certificate of Suitability (COS). The purpose of a (+/-)-MEFLOQUINE HCL CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of (+/-)-MEFLOQUINE HCL EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of (+/-)-MEFLOQUINE HCL to their clients by showing that a (+/-)-MEFLOQUINE HCL CEP has been issued for it. The manufacturer submits a (+/-)-MEFLOQUINE HCL CEP (COS) as part of the market authorization procedure, and it takes on the role of a (+/-)-MEFLOQUINE HCL CEP holder for the record. Additionally, the data presented in the (+/-)-MEFLOQUINE HCL CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the (+/-)-MEFLOQUINE HCL DMF.
A (+/-)-MEFLOQUINE HCL CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. (+/-)-MEFLOQUINE HCL 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 (+/-)-MEFLOQUINE HCL suppliers with CEP (COS) on PharmaCompass.
A (+/-)-MEFLOQUINE HCL written confirmation ((+/-)-MEFLOQUINE HCL WC) is an official document issued by a regulatory agency to a (+/-)-MEFLOQUINE HCL manufacturer, verifying that the manufacturing facility of a (+/-)-MEFLOQUINE HCL active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting (+/-)-MEFLOQUINE HCL APIs or (+/-)-MEFLOQUINE HCL finished pharmaceutical products to another nation, regulatory agencies frequently require a (+/-)-MEFLOQUINE HCL WC (written confirmation) as part of the regulatory process.
click here to find a list of (+/-)-MEFLOQUINE HCL 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 (+/-)-MEFLOQUINE HCL as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for (+/-)-MEFLOQUINE HCL 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 (+/-)-MEFLOQUINE HCL 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 (+/-)-MEFLOQUINE HCL and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a (+/-)-MEFLOQUINE HCL NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of (+/-)-MEFLOQUINE HCL suppliers with NDC on PharmaCompass.
(+/-)-MEFLOQUINE HCL 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 (+/-)-MEFLOQUINE HCL 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 (+/-)-MEFLOQUINE HCL GMP manufacturer or (+/-)-MEFLOQUINE HCL GMP API supplier for your needs.
A (+/-)-MEFLOQUINE HCL CoA (Certificate of Analysis) is a formal document that attests to (+/-)-MEFLOQUINE HCL's compliance with (+/-)-MEFLOQUINE HCL specifications and serves as a tool for batch-level quality control.
(+/-)-MEFLOQUINE HCL CoA mostly includes findings from lab analyses of a specific batch. For each (+/-)-MEFLOQUINE HCL 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.
(+/-)-MEFLOQUINE HCL may be tested according to a variety of international standards, such as European Pharmacopoeia ((+/-)-MEFLOQUINE HCL EP), (+/-)-MEFLOQUINE HCL JP (Japanese Pharmacopeia) and the US Pharmacopoeia ((+/-)-MEFLOQUINE HCL USP).