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API SUPPLIERS
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USDMF
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Rochem International Inc
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ABOUT THIS PAGE
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PharmaCompass offers a list of Selexipag 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 Selexipag manufacturer or Selexipag supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Selexipag manufacturer or Selexipag supplier.
PharmaCompass also assists you with knowing the Selexipag API Price utilized in the formulation of products. Selexipag API Price is not always fixed or binding as the Selexipag Price is obtained through a variety of data sources. The Selexipag Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A NS 304 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NS 304, including repackagers and relabelers. The FDA regulates NS 304 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NS 304 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 NS 304 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A NS 304 supplier is an individual or a company that provides NS 304 active pharmaceutical ingredient (API) or NS 304 finished formulations upon request. The NS 304 suppliers may include NS 304 API manufacturers, exporters, distributors and traders.
click here to find a list of NS 304 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A NS 304 DMF (Drug Master File) is a document detailing the whole manufacturing process of NS 304 active pharmaceutical ingredient (API) in detail. Different forms of NS 304 DMFs exist exist since differing nations have different regulations, such as NS 304 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A NS 304 DMF submitted to regulatory agencies in the US is known as a USDMF. NS 304 USDMF includes data on NS 304's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The NS 304 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of NS 304 suppliers with USDMF 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 NS 304 Drug Master File in Korea (NS 304 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of NS 304. The MFDS reviews the NS 304 KDMF as part of the drug registration process and uses the information provided in the NS 304 KDMF to evaluate the safety and efficacy of the drug.
After submitting a NS 304 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 NS 304 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of NS 304 suppliers with KDMF on PharmaCompass.
A NS 304 written confirmation (NS 304 WC) is an official document issued by a regulatory agency to a NS 304 manufacturer, verifying that the manufacturing facility of a NS 304 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting NS 304 APIs or NS 304 finished pharmaceutical products to another nation, regulatory agencies frequently require a NS 304 WC (written confirmation) as part of the regulatory process.
click here to find a list of NS 304 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 NS 304 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for NS 304 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 NS 304 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 NS 304 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a NS 304 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of NS 304 suppliers with NDC on PharmaCompass.
NS 304 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 NS 304 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 NS 304 GMP manufacturer or NS 304 GMP API supplier for your needs.
A NS 304 CoA (Certificate of Analysis) is a formal document that attests to NS 304's compliance with NS 304 specifications and serves as a tool for batch-level quality control.
NS 304 CoA mostly includes findings from lab analyses of a specific batch. For each NS 304 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.
NS 304 may be tested according to a variety of international standards, such as European Pharmacopoeia (NS 304 EP), NS 304 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (NS 304 USP).
