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