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