Synopsis
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JDMF
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DRUG PRODUCT COMPOSITIONS
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Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
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ASMF
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.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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USDMF
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-27
Pay. Date : 2016-12-28
DMF Number : 31213
Submission : 2017-01-05
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-03
Pay. Date : 2017-02-22
DMF Number : 31416
Submission : 2017-04-13
Status :
Type : II
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Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
About the Company : Honour is a leading global CDMO and a trusted manufacturer of specialty chemicals and ingredients. With seven world-class facilities built to meet global safety and quality standar...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
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We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q4 2023
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q4 2023
Registration Country : Germany
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Topical
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ABOUT THIS PAGE
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PharmaCompass offers a list of Macitentan 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 Macitentan manufacturer or Macitentan supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Macitentan manufacturer or Macitentan supplier.
PharmaCompass also assists you with knowing the Macitentan API Price utilized in the formulation of products. Macitentan API Price is not always fixed or binding as the Macitentan Price is obtained through a variety of data sources. The Macitentan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A opsumit manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of opsumit, including repackagers and relabelers. The FDA regulates opsumit manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. opsumit 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 opsumit manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A opsumit supplier is an individual or a company that provides opsumit active pharmaceutical ingredient (API) or opsumit finished formulations upon request. The opsumit suppliers may include opsumit API manufacturers, exporters, distributors and traders.
click here to find a list of opsumit suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A opsumit DMF (Drug Master File) is a document detailing the whole manufacturing process of opsumit active pharmaceutical ingredient (API) in detail. Different forms of opsumit DMFs exist exist since differing nations have different regulations, such as opsumit USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A opsumit DMF submitted to regulatory agencies in the US is known as a USDMF. opsumit USDMF includes data on opsumit's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The opsumit USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of opsumit 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 opsumit Drug Master File in Korea (opsumit KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of opsumit. The MFDS reviews the opsumit KDMF as part of the drug registration process and uses the information provided in the opsumit KDMF to evaluate the safety and efficacy of the drug.
After submitting a opsumit 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 opsumit API can apply through the Korea Drug Master File (KDMF).
click here to find a list of opsumit suppliers with KDMF on PharmaCompass.
A opsumit written confirmation (opsumit WC) is an official document issued by a regulatory agency to a opsumit manufacturer, verifying that the manufacturing facility of a opsumit active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting opsumit APIs or opsumit finished pharmaceutical products to another nation, regulatory agencies frequently require a opsumit WC (written confirmation) as part of the regulatory process.
click here to find a list of opsumit 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 opsumit as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for opsumit 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 opsumit 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 opsumit and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a opsumit NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of opsumit suppliers with NDC on PharmaCompass.
opsumit 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 opsumit 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 opsumit GMP manufacturer or opsumit GMP API supplier for your needs.
A opsumit CoA (Certificate of Analysis) is a formal document that attests to opsumit's compliance with opsumit specifications and serves as a tool for batch-level quality control.
opsumit CoA mostly includes findings from lab analyses of a specific batch. For each opsumit 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.
opsumit may be tested according to a variety of international standards, such as European Pharmacopoeia (opsumit EP), opsumit JP (Japanese Pharmacopeia) and the US Pharmacopoeia (opsumit USP).
