X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
0
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
45
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 Hydroxychloroquine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydroxychloroquine, including repackagers and relabelers. The FDA regulates Hydroxychloroquine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydroxychloroquine 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 Hydroxychloroquine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydroxychloroquine supplier is an individual or a company that provides Hydroxychloroquine active pharmaceutical ingredient (API) or Hydroxychloroquine finished formulations upon request. The Hydroxychloroquine suppliers may include Hydroxychloroquine API manufacturers, exporters, distributors and traders.
click here to find a list of Hydroxychloroquine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hydroxychloroquine DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydroxychloroquine active pharmaceutical ingredient (API) in detail. Different forms of Hydroxychloroquine DMFs exist exist since differing nations have different regulations, such as Hydroxychloroquine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydroxychloroquine DMF submitted to regulatory agencies in the US is known as a USDMF. Hydroxychloroquine USDMF includes data on Hydroxychloroquine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydroxychloroquine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydroxychloroquine 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 Hydroxychloroquine Drug Master File in Japan (Hydroxychloroquine JDMF) empowers Hydroxychloroquine 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 Hydroxychloroquine JDMF during the approval evaluation for pharmaceutical products. At the time of Hydroxychloroquine 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 Hydroxychloroquine 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 Hydroxychloroquine Drug Master File in Korea (Hydroxychloroquine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hydroxychloroquine. The MFDS reviews the Hydroxychloroquine KDMF as part of the drug registration process and uses the information provided in the Hydroxychloroquine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hydroxychloroquine 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 Hydroxychloroquine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hydroxychloroquine suppliers with KDMF on PharmaCompass.
A Hydroxychloroquine CEP of the European Pharmacopoeia monograph is often referred to as a Hydroxychloroquine Certificate of Suitability (COS). The purpose of a Hydroxychloroquine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hydroxychloroquine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hydroxychloroquine to their clients by showing that a Hydroxychloroquine CEP has been issued for it. The manufacturer submits a Hydroxychloroquine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hydroxychloroquine CEP holder for the record. Additionally, the data presented in the Hydroxychloroquine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hydroxychloroquine DMF.
A Hydroxychloroquine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hydroxychloroquine 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 Hydroxychloroquine suppliers with CEP (COS) on PharmaCompass.
A Hydroxychloroquine written confirmation (Hydroxychloroquine WC) is an official document issued by a regulatory agency to a Hydroxychloroquine manufacturer, verifying that the manufacturing facility of a Hydroxychloroquine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hydroxychloroquine APIs or Hydroxychloroquine finished pharmaceutical products to another nation, regulatory agencies frequently require a Hydroxychloroquine WC (written confirmation) as part of the regulatory process.
click here to find a list of Hydroxychloroquine 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 Hydroxychloroquine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hydroxychloroquine 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 Hydroxychloroquine 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 Hydroxychloroquine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hydroxychloroquine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hydroxychloroquine suppliers with NDC on PharmaCompass.
Hydroxychloroquine 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 Hydroxychloroquine 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 Hydroxychloroquine GMP manufacturer or Hydroxychloroquine GMP API supplier for your needs.
A Hydroxychloroquine CoA (Certificate of Analysis) is a formal document that attests to Hydroxychloroquine's compliance with Hydroxychloroquine specifications and serves as a tool for batch-level quality control.
Hydroxychloroquine CoA mostly includes findings from lab analyses of a specific batch. For each Hydroxychloroquine 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.
Hydroxychloroquine may be tested according to a variety of international standards, such as European Pharmacopoeia (Hydroxychloroquine EP), Hydroxychloroquine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hydroxychloroquine USP).
Market Place
