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ABOUT THIS PAGE
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PharmaCompass offers a list of Pranlukast 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 Pranlukast manufacturer or Pranlukast supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pranlukast manufacturer or Pranlukast supplier.
PharmaCompass also assists you with knowing the Pranlukast API Price utilized in the formulation of products. Pranlukast API Price is not always fixed or binding as the Pranlukast Price is obtained through a variety of data sources. The Pranlukast Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Pranlukast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pranlukast, including repackagers and relabelers. The FDA regulates Pranlukast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pranlukast 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 Pranlukast manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pranlukast supplier is an individual or a company that provides Pranlukast active pharmaceutical ingredient (API) or Pranlukast finished formulations upon request. The Pranlukast suppliers may include Pranlukast API manufacturers, exporters, distributors and traders.
click here to find a list of Pranlukast suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Pranlukast Drug Master File in Japan (Pranlukast JDMF) empowers Pranlukast API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Pranlukast JDMF during the approval evaluation for pharmaceutical products. At the time of Pranlukast JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Pranlukast suppliers with JDMF 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 Pranlukast Drug Master File in Korea (Pranlukast KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pranlukast. The MFDS reviews the Pranlukast KDMF as part of the drug registration process and uses the information provided in the Pranlukast KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pranlukast 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 Pranlukast API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pranlukast suppliers with KDMF on PharmaCompass.
A Pranlukast written confirmation (Pranlukast WC) is an official document issued by a regulatory agency to a Pranlukast manufacturer, verifying that the manufacturing facility of a Pranlukast active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pranlukast APIs or Pranlukast finished pharmaceutical products to another nation, regulatory agencies frequently require a Pranlukast WC (written confirmation) as part of the regulatory process.
click here to find a list of Pranlukast suppliers with Written Confirmation (WC) on PharmaCompass.
Pranlukast 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 Pranlukast 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 Pranlukast GMP manufacturer or Pranlukast GMP API supplier for your needs.
A Pranlukast CoA (Certificate of Analysis) is a formal document that attests to Pranlukast's compliance with Pranlukast specifications and serves as a tool for batch-level quality control.
Pranlukast CoA mostly includes findings from lab analyses of a specific batch. For each Pranlukast 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.
Pranlukast may be tested according to a variety of international standards, such as European Pharmacopoeia (Pranlukast EP), Pranlukast JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pranlukast USP).
