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DMF Number : 20692
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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 Hydroxychloroquine Sulphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydroxychloroquine Sulphate, including repackagers and relabelers. The FDA regulates Hydroxychloroquine Sulphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydroxychloroquine Sulphate 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 Sulphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydroxychloroquine Sulphate supplier is an individual or a company that provides Hydroxychloroquine Sulphate active pharmaceutical ingredient (API) or Hydroxychloroquine Sulphate finished formulations upon request. The Hydroxychloroquine Sulphate suppliers may include Hydroxychloroquine Sulphate API manufacturers, exporters, distributors and traders.
click here to find a list of Hydroxychloroquine Sulphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hydroxychloroquine Sulphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydroxychloroquine Sulphate active pharmaceutical ingredient (API) in detail. Different forms of Hydroxychloroquine Sulphate DMFs exist exist since differing nations have different regulations, such as Hydroxychloroquine Sulphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydroxychloroquine Sulphate DMF submitted to regulatory agencies in the US is known as a USDMF. Hydroxychloroquine Sulphate USDMF includes data on Hydroxychloroquine Sulphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydroxychloroquine Sulphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydroxychloroquine Sulphate 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 Sulphate Drug Master File in Japan (Hydroxychloroquine Sulphate JDMF) empowers Hydroxychloroquine Sulphate 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 Sulphate JDMF during the approval evaluation for pharmaceutical products. At the time of Hydroxychloroquine Sulphate 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 Sulphate 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 Sulphate Drug Master File in Korea (Hydroxychloroquine Sulphate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hydroxychloroquine Sulphate. The MFDS reviews the Hydroxychloroquine Sulphate KDMF as part of the drug registration process and uses the information provided in the Hydroxychloroquine Sulphate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hydroxychloroquine Sulphate 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 Sulphate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hydroxychloroquine Sulphate suppliers with KDMF on PharmaCompass.
A Hydroxychloroquine Sulphate CEP of the European Pharmacopoeia monograph is often referred to as a Hydroxychloroquine Sulphate Certificate of Suitability (COS). The purpose of a Hydroxychloroquine Sulphate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hydroxychloroquine Sulphate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hydroxychloroquine Sulphate to their clients by showing that a Hydroxychloroquine Sulphate CEP has been issued for it. The manufacturer submits a Hydroxychloroquine Sulphate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hydroxychloroquine Sulphate CEP holder for the record. Additionally, the data presented in the Hydroxychloroquine Sulphate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hydroxychloroquine Sulphate DMF.
A Hydroxychloroquine Sulphate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hydroxychloroquine Sulphate 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 Sulphate suppliers with CEP (COS) on PharmaCompass.
A Hydroxychloroquine Sulphate written confirmation (Hydroxychloroquine Sulphate WC) is an official document issued by a regulatory agency to a Hydroxychloroquine Sulphate manufacturer, verifying that the manufacturing facility of a Hydroxychloroquine Sulphate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hydroxychloroquine Sulphate APIs or Hydroxychloroquine Sulphate finished pharmaceutical products to another nation, regulatory agencies frequently require a Hydroxychloroquine Sulphate WC (written confirmation) as part of the regulatory process.
click here to find a list of Hydroxychloroquine Sulphate 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 Sulphate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hydroxychloroquine Sulphate 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 Sulphate 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 Sulphate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hydroxychloroquine Sulphate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hydroxychloroquine Sulphate suppliers with NDC on PharmaCompass.
Hydroxychloroquine Sulphate 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 Sulphate 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 Sulphate GMP manufacturer or Hydroxychloroquine Sulphate GMP API supplier for your needs.
A Hydroxychloroquine Sulphate CoA (Certificate of Analysis) is a formal document that attests to Hydroxychloroquine Sulphate's compliance with Hydroxychloroquine Sulphate specifications and serves as a tool for batch-level quality control.
Hydroxychloroquine Sulphate CoA mostly includes findings from lab analyses of a specific batch. For each Hydroxychloroquine Sulphate 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 Sulphate may be tested according to a variety of international standards, such as European Pharmacopoeia (Hydroxychloroquine Sulphate EP), Hydroxychloroquine Sulphate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hydroxychloroquine Sulphate USP).
