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  • TABLET;ORAL - 10MG
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Looking for 107753-78-6 / Zafirlukast API manufacturers, exporters & distributors?

Zafirlukast manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Zafirlukast 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 Zafirlukast manufacturer or Zafirlukast supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Zafirlukast manufacturer or Zafirlukast supplier.

PharmaCompass also assists you with knowing the Zafirlukast API Price utilized in the formulation of products. Zafirlukast API Price is not always fixed or binding as the Zafirlukast Price is obtained through a variety of data sources. The Zafirlukast Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Zafirlukast

Synonyms

107753-78-6, Accolate, Olmoran, Ici-204219, Cyclopentyl (3-(2-methoxy-4-((o-tolylsulfonyl)carbamoyl)benzyl)-1-methyl-1h-indol-5-yl)carbamate, Accoleit

Cas Number

107753-78-6

Unique Ingredient Identifier (UNII)

XZ629S5L50

About Zafirlukast

Zafirlukast is a tolyl compound and leukotriene receptor antagonist (LTRA), with anti-asthmatic and potential capsular contracture-preventing activities. Upon administration, zafirlukast selectively and competitively binds to and blocks the cysteinyl leukotriene 1 receptor (CYSLTR1), thereby preventing the potent pro-inflammatory mediators leukotriene C4, D4 and E4 from binding. This prevents leukotriene-mediated actions, including enhanced migration of eosinophils and neutrophils, increased adhesion of leukocytes, increased monocyte and neutrophil aggregation, increased airway edema, inflammation, capillary permeability and bronchoconstriction. In addition, zafirlukast may decrease collagen deposition, fibrosis, and capsular thickness after implantation, thereby preventing scar tissue.

Zafirlukast Manufacturers

A Zafirlukast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zafirlukast, including repackagers and relabelers. The FDA regulates Zafirlukast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zafirlukast 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 Zafirlukast manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Zafirlukast Suppliers

A Zafirlukast supplier is an individual or a company that provides Zafirlukast active pharmaceutical ingredient (API) or Zafirlukast finished formulations upon request. The Zafirlukast suppliers may include Zafirlukast API manufacturers, exporters, distributors and traders.

click here to find a list of Zafirlukast suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Zafirlukast USDMF

A Zafirlukast DMF (Drug Master File) is a document detailing the whole manufacturing process of Zafirlukast active pharmaceutical ingredient (API) in detail. Different forms of Zafirlukast DMFs exist exist since differing nations have different regulations, such as Zafirlukast USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Zafirlukast DMF submitted to regulatory agencies in the US is known as a USDMF. Zafirlukast USDMF includes data on Zafirlukast's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zafirlukast USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Zafirlukast suppliers with USDMF on PharmaCompass.

Zafirlukast WC

A Zafirlukast written confirmation (Zafirlukast WC) is an official document issued by a regulatory agency to a Zafirlukast manufacturer, verifying that the manufacturing facility of a Zafirlukast active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Zafirlukast APIs or Zafirlukast finished pharmaceutical products to another nation, regulatory agencies frequently require a Zafirlukast WC (written confirmation) as part of the regulatory process.

click here to find a list of Zafirlukast suppliers with Written Confirmation (WC) on PharmaCompass.

Zafirlukast 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 Zafirlukast as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Zafirlukast 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 Zafirlukast 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 Zafirlukast and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zafirlukast NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Zafirlukast suppliers with NDC on PharmaCompass.

Zafirlukast GMP

Zafirlukast 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 Zafirlukast 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 Zafirlukast GMP manufacturer or Zafirlukast GMP API supplier for your needs.

Zafirlukast CoA

A Zafirlukast CoA (Certificate of Analysis) is a formal document that attests to Zafirlukast's compliance with Zafirlukast specifications and serves as a tool for batch-level quality control.

Zafirlukast CoA mostly includes findings from lab analyses of a specific batch. For each Zafirlukast 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.

Zafirlukast may be tested according to a variety of international standards, such as European Pharmacopoeia (Zafirlukast EP), Zafirlukast JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zafirlukast 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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