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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Th...
With Fermion, start the journey of your innovative API.
About the Company : Fermion is fully owned subsidiary of Orion Corporation & headquartered in Espoo, Finland. Together with Orion we are a fully integrated CDMO & offer services covering both APIs & F...
Temad- We think of world-class quality.
About the Company : Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Midd...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
About the Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for critical and high-g...
Atman Pharma Private Limited: A One Stop Solution Provider to All Your API Needs.
About the Company : Atman Pharma Private Limited is a fully integrated pharmaceutical company that has distinguished itself as a leader in Bulk Drugs (API) marketing both domestically in India and ove...
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
About the Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & operation facilities ar...
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
About the Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pilot plants, and produ...
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
About the Company : Zeal MediPharma is a globally recognized Star One Export House, serving customers in over 50 countries for more than two decades. We specialize in sourcing and exporting high-quali...
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DOSAGE - TABLET;ORAL - 200MG
USFDA APPLICATION NUMBER - 214581
DOSAGE - TABLET;ORAL - 300MG
USFDA APPLICATION NUMBER - 214581
DOSAGE - TABLET;ORAL - 200MG
USFDA APPLICATION NUMBER - 9768
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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 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.
click here to find a list of Hydroxychloroquine Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
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.
click here to find a list of Hydroxychloroquine Sulfate 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 Sulfate Drug Master File in Japan (Hydroxychloroquine Sulfate JDMF) empowers Hydroxychloroquine Sulfate 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 Sulfate JDMF during the approval evaluation for pharmaceutical products. At the time of Hydroxychloroquine Sulfate 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 Sulfate 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 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).
click here to find a list of Hydroxychloroquine Sulfate suppliers with KDMF on PharmaCompass.
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.
click here to find a list of Hydroxychloroquine Sulfate suppliers with CEP (COS) on PharmaCompass.
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.
click here to find a list of Hydroxychloroquine Sulfate 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 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.
click here to find a list of Hydroxychloroquine Sulfate suppliers with NDC on PharmaCompass.
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).
