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Looking for 162401-32-3 / Roflumilast API manufacturers, exporters & distributors?

Roflumilast manufacturers, exporters & distributors 1

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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.

API | Excipient name

Roflumilast

Synonyms

162401-32-3, Daxas, 3-(cyclopropylmethoxy)-n-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide, Daliresp, By217, Byk20869

Cas Number

162401-32-3

Unique Ingredient Identifier (UNII)

0P6C6ZOP5U

About Roflumilast

Roflumilast is an orally available, long-acting inhibitor of phosphodiesterase (PDE) type 4 (PDE4), with anti-inflammatory and potential antineoplastic activities. Upon administration, roflumilast and its active metabolite roflumilast N-oxide selectively and competitively bind to and inhibit PDE4, which leads to an increase of both intracellular levels of cyclic-3',5'-adenosine monophosphate (cAMP) and cAMP-mediated signaling. cAMP prevents phosphorylation of spleen tyrosine kinase (SYK) and abrogates activation of the PI3K/AKT/mTOR signaling pathway, which may result in the induction of apoptosis. PDE4, a member of the PDE superfamily that hydrolyses cAMP and 3',5'-cyclic guanosine monophosphate (cGMP) to their inactive 5' monophosphates, is upregulated in a variety of cancers and may contribute to chemoresistance; it also plays a key role in inflammation, especially in inflammatory airway diseases.

Roflumilast Manufacturers

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.

Roflumilast Suppliers

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.

Roflumilast USDMF

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.

Roflumilast KDMF

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.

Roflumilast WC

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.

Roflumilast NDC

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).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Roflumilast API and other APIs are published in this directory by the FDA.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Roflumilast CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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