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API SUPPLIERS
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Vital Laboratories – Trusted Global Manufacturer of Quinine and Antimalarial APIs Since 1998
With Fermion, start the journey of your innovative API.
CEP/COS 
JDMF
NDC
Temad- We think of world-class quality.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Jai Radhe Sales is your partner for all your sourcing needs.
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
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USDMF
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2022-02-16
Pay. Date : 2022-02-11
DMF Number : 20692
Submission : 2007-07-17
Status :
Type : II
With Fermion, start the journey of your innovative API.
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-26
Pay. Date : 2016-01-21
DMF Number : 30014
Submission : 2015-11-24
Status :
Type : II
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-11
Pay. Date : 2015-09-08
DMF Number : 8619
Submission : 1990-06-27
Status :
Type : II
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With Fermion, start the journey of your innovative API.
Certificate Number : CEP 2017-176 - Rev 02
Status : Valid
Issue Date : 2024-01-03
Type : Chemical
Substance Number : 2849
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Certificate Number : CEP 2017-297 - Rev 03
Status : Valid
Issue Date : 2024-08-28
Type : Chemical
Substance Number : 2849
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
With Fermion, start the journey of your innovative API.
Registration Number : 305MF10090
Registrant's Address : Koivu-Mankkaan tie 6A, FI-02200 Espoo, Finland
Initial Date of Registration : 2023-08-02
Latest Date of Registration : 2023-08-02
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Vital Laboratories – Trusted Global Manufacturer of Quinine and Antimalarial APIs Since 1998
Hydroxychloroquine Sulfate EP/BP
Date of Issue : 2021-12-16
Valid Till : 2024-05-20
Written Confirmation Number : WC-0303n
Address of the Firm : Plant-1, Plot No 1416 to 1421, 1507/1&2, 1601, Phase-lll, GIDC estate, Vapi, Val...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Hydroxychloroquine Sulphate BP/Ph.Eur/USP
Date of Issue : 2024-08-16
Valid Till : 2027-02-26
Written Confirmation Number : WC-0494
Address of the Firm : (Unit-1), Sy No 29, Tupakulagudem (V), Pochavaram Panchayat, Tallapudi (M), West...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Hydroxychloroquine Sulphate IP
Date of Issue : 2024-08-16
Valid Till : 2027-02-26
Written Confirmation Number : WC-0494
Address of the Firm : (Unit-1), Sy No 29, Tupakulagudem (V), Pochavaram Panchayat, Tallapudi (M), West...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-03-10
Registration Number : 20210310-209-J-787
Manufacturer Name : EUROAPI Hungary Ltd.
Manufacturer Address : To utca 1-5, Budapest, 1045, Hungary
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI focuses on reinventing active ingredient solutions to sustainably meet the needs of customers and patients worldwide. The company is a leading API player with a portfolio o...
Vital Laboratories – Trusted Global Manufacturer of Quinine and Antimalarial APIs Since 1998
About the Company : Vital Laboratories is an Active Pharmaceutical Ingredients (API) manufacturer established in 1998, initially focused on quinine derivatives. Vital is now among the largest global m...
With Fermion, start the journey of your innovative API.
About the Company : Fermion, a wholly owned subsidiary of Orion Corporation and headquartered in Espoo, Finland, is a fully integrated CDMO offering API and formulation services. Its API portfolio inc...
Temad- We think of world-class quality.
About the Company : Temad Co., established in 1997, is one of Iran's largest API producers and an innovative manufacturer of narcotic and non-narcotic products in the Middle East. It complies with Ira...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
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 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-growth therapeutic 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 with a focus on rapid development and cost-effective production. Its fully equipped research labs, pilot...
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
About the Company : Zeal Medipharma is a Star-rated Export House serving customers in over 50 countries for more than two decades. The company specializes in sourcing and exporting APIs for human and ...
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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 Hydroxychlorochin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydroxychlorochin, including repackagers and relabelers. The FDA regulates Hydroxychlorochin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydroxychlorochin 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 Hydroxychlorochin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydroxychlorochin supplier is an individual or a company that provides Hydroxychlorochin active pharmaceutical ingredient (API) or Hydroxychlorochin finished formulations upon request. The Hydroxychlorochin suppliers may include Hydroxychlorochin API manufacturers, exporters, distributors and traders.
click here to find a list of Hydroxychlorochin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hydroxychlorochin DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydroxychlorochin active pharmaceutical ingredient (API) in detail. Different forms of Hydroxychlorochin DMFs exist exist since differing nations have different regulations, such as Hydroxychlorochin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydroxychlorochin DMF submitted to regulatory agencies in the US is known as a USDMF. Hydroxychlorochin USDMF includes data on Hydroxychlorochin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydroxychlorochin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydroxychlorochin 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 Hydroxychlorochin Drug Master File in Japan (Hydroxychlorochin JDMF) empowers Hydroxychlorochin 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 Hydroxychlorochin JDMF during the approval evaluation for pharmaceutical products. At the time of Hydroxychlorochin 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 Hydroxychlorochin 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 Hydroxychlorochin Drug Master File in Korea (Hydroxychlorochin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hydroxychlorochin. The MFDS reviews the Hydroxychlorochin KDMF as part of the drug registration process and uses the information provided in the Hydroxychlorochin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hydroxychlorochin 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 Hydroxychlorochin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hydroxychlorochin suppliers with KDMF on PharmaCompass.
A Hydroxychlorochin CEP of the European Pharmacopoeia monograph is often referred to as a Hydroxychlorochin Certificate of Suitability (COS). The purpose of a Hydroxychlorochin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hydroxychlorochin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hydroxychlorochin to their clients by showing that a Hydroxychlorochin CEP has been issued for it. The manufacturer submits a Hydroxychlorochin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hydroxychlorochin CEP holder for the record. Additionally, the data presented in the Hydroxychlorochin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hydroxychlorochin DMF.
A Hydroxychlorochin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hydroxychlorochin 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 Hydroxychlorochin suppliers with CEP (COS) on PharmaCompass.
A Hydroxychlorochin written confirmation (Hydroxychlorochin WC) is an official document issued by a regulatory agency to a Hydroxychlorochin manufacturer, verifying that the manufacturing facility of a Hydroxychlorochin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hydroxychlorochin APIs or Hydroxychlorochin finished pharmaceutical products to another nation, regulatory agencies frequently require a Hydroxychlorochin WC (written confirmation) as part of the regulatory process.
click here to find a list of Hydroxychlorochin 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 Hydroxychlorochin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hydroxychlorochin 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 Hydroxychlorochin 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 Hydroxychlorochin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hydroxychlorochin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hydroxychlorochin suppliers with NDC on PharmaCompass.
Hydroxychlorochin 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 Hydroxychlorochin 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 Hydroxychlorochin GMP manufacturer or Hydroxychlorochin GMP API supplier for your needs.
A Hydroxychlorochin CoA (Certificate of Analysis) is a formal document that attests to Hydroxychlorochin's compliance with Hydroxychlorochin specifications and serves as a tool for batch-level quality control.
Hydroxychlorochin CoA mostly includes findings from lab analyses of a specific batch. For each Hydroxychlorochin 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.
Hydroxychlorochin may be tested according to a variety of international standards, such as European Pharmacopoeia (Hydroxychlorochin EP), Hydroxychlorochin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hydroxychlorochin USP).
