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