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Australia
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API SUPPLIERS
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
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KDMF
ASMF
M2i Group, an integrated CDMO, is your French partner for development & manufacturing in fine chemistry.
Inke S.A: APIs manufacturing plant.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Mesochem is focused on incessant innovation along with the R&D of new APIs.
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
ASMF
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
ASMF
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USDMF
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-05
Pay. Date : 2014-07-23
DMF Number : 28471
Submission : 2014-07-31
Status :
Type : II
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Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
About the Company : Interquim, founded in 1978, is now part of the Ferrer HealthTech division. Interquim specializes in the development of competitive processes for manufacturing high added-value APIs...
M2i Group, an integrated CDMO, is your French partner for development & manufacturing in fine chemistry.
About the Company : Integrated solutions for all your projects.
M2i Group provides integrated solutions for all your projects. We offer our clients an integrated partner, from early development...
Inke S.A: APIs manufacturing plant.
About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...
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, ...
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...
Mesochem is focused on incessant innovation along with the R&D of new APIs.
About the Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine c...
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DOSAGE - TABLET;ORAL - 250MCG
USFDA APPLICATION NUMBER - 22522
DOSAGE - TABLET;ORAL - 500MCG
USFDA APPLICATION NUMBER - 22522
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ABOUT THIS PAGE
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PharmaCompass offers a list of Roflumilast 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 Roflumilast manufacturer or Roflumilast supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Roflumilast manufacturer or Roflumilast supplier.
PharmaCompass also assists you with knowing the Roflumilast API Price utilized in the formulation of products. Roflumilast API Price is not always fixed or binding as the Roflumilast Price is obtained through a variety of data sources. The Roflumilast Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A ROF manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ROF, including repackagers and relabelers. The FDA regulates ROF manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ROF 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 ROF manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ROF supplier is an individual or a company that provides ROF active pharmaceutical ingredient (API) or ROF finished formulations upon request. The ROF suppliers may include ROF API manufacturers, exporters, distributors and traders.
click here to find a list of ROF suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ROF DMF (Drug Master File) is a document detailing the whole manufacturing process of ROF active pharmaceutical ingredient (API) in detail. Different forms of ROF DMFs exist exist since differing nations have different regulations, such as ROF USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ROF DMF submitted to regulatory agencies in the US is known as a USDMF. ROF USDMF includes data on ROF's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ROF USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ROF 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 ROF Drug Master File in Korea (ROF KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ROF. The MFDS reviews the ROF KDMF as part of the drug registration process and uses the information provided in the ROF KDMF to evaluate the safety and efficacy of the drug.
After submitting a ROF 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 ROF API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ROF suppliers with KDMF on PharmaCompass.
A ROF written confirmation (ROF WC) is an official document issued by a regulatory agency to a ROF manufacturer, verifying that the manufacturing facility of a ROF active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting ROF APIs or ROF finished pharmaceutical products to another nation, regulatory agencies frequently require a ROF WC (written confirmation) as part of the regulatory process.
click here to find a list of ROF 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 ROF as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ROF 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 ROF 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 ROF and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ROF NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ROF suppliers with NDC on PharmaCompass.
ROF 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 ROF 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 ROF GMP manufacturer or ROF GMP API supplier for your needs.
A ROF CoA (Certificate of Analysis) is a formal document that attests to ROF's compliance with ROF specifications and serves as a tool for batch-level quality control.
ROF CoA mostly includes findings from lab analyses of a specific batch. For each ROF 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.
ROF may be tested according to a variety of international standards, such as European Pharmacopoeia (ROF EP), ROF JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ROF USP).
