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API SUPPLIERS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
EU-WC
NDC
Maithri Drugs: Dedicated to your API needs.
EU-WC
ASMF, CA...
Maithri Drugs: Dedicated to your API needs.
ASMF, CA...
Maithri Drugs: Dedicated to your API needs.
ASMF, CA...
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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 Uptravi manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Uptravi, including repackagers and relabelers. The FDA regulates Uptravi manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Uptravi 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 Uptravi manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Uptravi supplier is an individual or a company that provides Uptravi active pharmaceutical ingredient (API) or Uptravi finished formulations upon request. The Uptravi suppliers may include Uptravi API manufacturers, exporters, distributors and traders.
click here to find a list of Uptravi suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Uptravi DMF (Drug Master File) is a document detailing the whole manufacturing process of Uptravi active pharmaceutical ingredient (API) in detail. Different forms of Uptravi DMFs exist exist since differing nations have different regulations, such as Uptravi USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Uptravi DMF submitted to regulatory agencies in the US is known as a USDMF. Uptravi USDMF includes data on Uptravi's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Uptravi USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Uptravi 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 Uptravi Drug Master File in Korea (Uptravi KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Uptravi. The MFDS reviews the Uptravi KDMF as part of the drug registration process and uses the information provided in the Uptravi KDMF to evaluate the safety and efficacy of the drug.
After submitting a Uptravi 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 Uptravi API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Uptravi suppliers with KDMF on PharmaCompass.
A Uptravi written confirmation (Uptravi WC) is an official document issued by a regulatory agency to a Uptravi manufacturer, verifying that the manufacturing facility of a Uptravi active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Uptravi APIs or Uptravi finished pharmaceutical products to another nation, regulatory agencies frequently require a Uptravi WC (written confirmation) as part of the regulatory process.
click here to find a list of Uptravi 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 Uptravi as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Uptravi 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 Uptravi 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 Uptravi and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Uptravi NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Uptravi suppliers with NDC on PharmaCompass.
Uptravi 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 Uptravi 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 Uptravi GMP manufacturer or Uptravi GMP API supplier for your needs.
A Uptravi CoA (Certificate of Analysis) is a formal document that attests to Uptravi's compliance with Uptravi specifications and serves as a tool for batch-level quality control.
Uptravi CoA mostly includes findings from lab analyses of a specific batch. For each Uptravi 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.
Uptravi may be tested according to a variety of international standards, such as European Pharmacopoeia (Uptravi EP), Uptravi JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Uptravi USP).
