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API SUPPLIERS
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USDMF
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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 Prestwick3_000520 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prestwick3_000520, including repackagers and relabelers. The FDA regulates Prestwick3_000520 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prestwick3_000520 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 Prestwick3_000520 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prestwick3_000520 supplier is an individual or a company that provides Prestwick3_000520 active pharmaceutical ingredient (API) or Prestwick3_000520 finished formulations upon request. The Prestwick3_000520 suppliers may include Prestwick3_000520 API manufacturers, exporters, distributors and traders.
click here to find a list of Prestwick3_000520 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prestwick3_000520 DMF (Drug Master File) is a document detailing the whole manufacturing process of Prestwick3_000520 active pharmaceutical ingredient (API) in detail. Different forms of Prestwick3_000520 DMFs exist exist since differing nations have different regulations, such as Prestwick3_000520 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prestwick3_000520 DMF submitted to regulatory agencies in the US is known as a USDMF. Prestwick3_000520 USDMF includes data on Prestwick3_000520's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prestwick3_000520 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prestwick3_000520 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 Prestwick3_000520 Drug Master File in Japan (Prestwick3_000520 JDMF) empowers Prestwick3_000520 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 Prestwick3_000520 JDMF during the approval evaluation for pharmaceutical products. At the time of Prestwick3_000520 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 Prestwick3_000520 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 Prestwick3_000520 Drug Master File in Korea (Prestwick3_000520 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Prestwick3_000520. The MFDS reviews the Prestwick3_000520 KDMF as part of the drug registration process and uses the information provided in the Prestwick3_000520 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Prestwick3_000520 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 Prestwick3_000520 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Prestwick3_000520 suppliers with KDMF on PharmaCompass.
A Prestwick3_000520 CEP of the European Pharmacopoeia monograph is often referred to as a Prestwick3_000520 Certificate of Suitability (COS). The purpose of a Prestwick3_000520 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Prestwick3_000520 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Prestwick3_000520 to their clients by showing that a Prestwick3_000520 CEP has been issued for it. The manufacturer submits a Prestwick3_000520 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Prestwick3_000520 CEP holder for the record. Additionally, the data presented in the Prestwick3_000520 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Prestwick3_000520 DMF.
A Prestwick3_000520 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Prestwick3_000520 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 Prestwick3_000520 suppliers with CEP (COS) on PharmaCompass.
A Prestwick3_000520 written confirmation (Prestwick3_000520 WC) is an official document issued by a regulatory agency to a Prestwick3_000520 manufacturer, verifying that the manufacturing facility of a Prestwick3_000520 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Prestwick3_000520 APIs or Prestwick3_000520 finished pharmaceutical products to another nation, regulatory agencies frequently require a Prestwick3_000520 WC (written confirmation) as part of the regulatory process.
click here to find a list of Prestwick3_000520 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 Prestwick3_000520 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Prestwick3_000520 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 Prestwick3_000520 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 Prestwick3_000520 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Prestwick3_000520 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Prestwick3_000520 suppliers with NDC on PharmaCompass.
Prestwick3_000520 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 Prestwick3_000520 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 Prestwick3_000520 GMP manufacturer or Prestwick3_000520 GMP API supplier for your needs.
A Prestwick3_000520 CoA (Certificate of Analysis) is a formal document that attests to Prestwick3_000520's compliance with Prestwick3_000520 specifications and serves as a tool for batch-level quality control.
Prestwick3_000520 CoA mostly includes findings from lab analyses of a specific batch. For each Prestwick3_000520 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.
Prestwick3_000520 may be tested according to a variety of international standards, such as European Pharmacopoeia (Prestwick3_000520 EP), Prestwick3_000520 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Prestwick3_000520 USP).
