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CEP/COS
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JDMF
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VMF
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EDQM
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USP
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JP
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Australia
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Weekly News Recap #Phispers
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
Inke S.A: APIs manufacturing plant.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
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
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
Lead Product(s) : Roflumilast,Inapplicable
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Senores Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Acquisition
Senores Pharma Gains After Arm Inks Pact to Acquire Roflumilast Tablets
Details : Senores acquire the USFDA-approved abbreviated new drug application for Roflumilast, indicated as a treatment to reduce the risk of COPD exacerbations, from Breckenridge.
Product Name : Roflumilast-Generic
Product Type : Miscellaneous
Upfront Cash : Undisclosed
February 21, 2025
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Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
CAS Number : 5911-08-0
End Use API : Roflumilast
About The Company : MINAKEM is a cGMP custom manufacturer specializing in small molecule APIs, HPAPIs, and steroids. Its highly skilled R&D teams, supported by strong analytical an...
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
CAS Number : 7051-34-5
End Use API : Roflumilast
About The Company : MINAKEM is a cGMP custom manufacturer specializing in small molecule APIs, HPAPIs, and steroids. Its highly skilled R&D teams, supported by strong analytical an...
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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 Roflumilast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Roflumilast, including repackagers and relabelers. The FDA regulates Roflumilast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Roflumilast 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 Roflumilast manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Roflumilast supplier is an individual or a company that provides Roflumilast active pharmaceutical ingredient (API) or Roflumilast finished formulations upon request. The Roflumilast suppliers may include Roflumilast API manufacturers, exporters, distributors and traders.
click here to find a list of Roflumilast suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Roflumilast DMF (Drug Master File) is a document detailing the whole manufacturing process of Roflumilast active pharmaceutical ingredient (API) in detail. Different forms of Roflumilast DMFs exist exist since differing nations have different regulations, such as Roflumilast USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Roflumilast DMF submitted to regulatory agencies in the US is known as a USDMF. Roflumilast USDMF includes data on Roflumilast's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Roflumilast USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Roflumilast 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 Roflumilast Drug Master File in Korea (Roflumilast KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Roflumilast. The MFDS reviews the Roflumilast KDMF as part of the drug registration process and uses the information provided in the Roflumilast KDMF to evaluate the safety and efficacy of the drug.
After submitting a Roflumilast 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 Roflumilast API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Roflumilast suppliers with KDMF on PharmaCompass.
A Roflumilast written confirmation (Roflumilast WC) is an official document issued by a regulatory agency to a Roflumilast manufacturer, verifying that the manufacturing facility of a Roflumilast active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Roflumilast APIs or Roflumilast finished pharmaceutical products to another nation, regulatory agencies frequently require a Roflumilast WC (written confirmation) as part of the regulatory process.
click here to find a list of Roflumilast 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 Roflumilast as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Roflumilast 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 Roflumilast 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 Roflumilast and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Roflumilast NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Roflumilast suppliers with NDC on PharmaCompass.
Roflumilast 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 Roflumilast 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 Roflumilast GMP manufacturer or Roflumilast GMP API supplier for your needs.
A Roflumilast CoA (Certificate of Analysis) is a formal document that attests to Roflumilast's compliance with Roflumilast specifications and serves as a tool for batch-level quality control.
Roflumilast CoA mostly includes findings from lab analyses of a specific batch. For each Roflumilast 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.
Roflumilast may be tested according to a variety of international standards, such as European Pharmacopoeia (Roflumilast EP), Roflumilast JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Roflumilast USP).
