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