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Looking for 100299-08-9 / Pemirolast API manufacturers, exporters & distributors?

Pemirolast manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Pemirolast

Synonyms

100299-08-9, Alamast, Pemirolast potassium salt, Pemilaston, Alegysal, Bmy 26517

Cas Number

100299-08-9

Unique Ingredient Identifier (UNII)

497A17OUUE

About Pemirolast

Pemirolast Potassium is the potassium salt form of pemirolast, a pyrimidinone derivative with antiallergic property. Pemirolast potassium exerts its action by blocking the antigen-mediated calcium ion influx into mast cells. This prevents mast cell degranulation, resulting in mast cell stabilization and inhibition of the release of inflammatory mediators, histamine and leukotrienes, which are involved in the allergic process. Pemirolast potassium also prevents inflammatory mediator release from eosinophils.

Pemirolast Manufacturers

A Pemirolast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pemirolast, including repackagers and relabelers. The FDA regulates Pemirolast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pemirolast API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Pemirolast Suppliers

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

Pemirolast KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Pemirolast Drug Master File in Korea (Pemirolast KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pemirolast. The MFDS reviews the Pemirolast KDMF as part of the drug registration process and uses the information provided in the Pemirolast KDMF to evaluate the safety and efficacy of the drug.

After submitting a Pemirolast 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 Pemirolast API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Pemirolast suppliers with KDMF on PharmaCompass.

Pemirolast GMP

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

Pemirolast CoA

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

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

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