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ABOUT THIS PAGE
A Pranlukast Hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pranlukast Hydrate, including repackagers and relabelers. The FDA regulates Pranlukast Hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pranlukast Hydrate 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 Hydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pranlukast Hydrate supplier is an individual or a company that provides Pranlukast Hydrate active pharmaceutical ingredient (API) or Pranlukast Hydrate finished formulations upon request. The Pranlukast Hydrate suppliers may include Pranlukast Hydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Pranlukast Hydrate 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 Hydrate Drug Master File in Japan (Pranlukast Hydrate JDMF) empowers Pranlukast Hydrate 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 Hydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Pranlukast Hydrate 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 Hydrate 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 Hydrate Drug Master File in Korea (Pranlukast Hydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pranlukast Hydrate. The MFDS reviews the Pranlukast Hydrate KDMF as part of the drug registration process and uses the information provided in the Pranlukast Hydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pranlukast Hydrate 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 Hydrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pranlukast Hydrate suppliers with KDMF on PharmaCompass.
A Pranlukast Hydrate written confirmation (Pranlukast Hydrate WC) is an official document issued by a regulatory agency to a Pranlukast Hydrate manufacturer, verifying that the manufacturing facility of a Pranlukast Hydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pranlukast Hydrate APIs or Pranlukast Hydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Pranlukast Hydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Pranlukast Hydrate suppliers with Written Confirmation (WC) on PharmaCompass.
Pranlukast Hydrate 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 Hydrate 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 Hydrate GMP manufacturer or Pranlukast Hydrate GMP API supplier for your needs.
A Pranlukast Hydrate CoA (Certificate of Analysis) is a formal document that attests to Pranlukast Hydrate's compliance with Pranlukast Hydrate specifications and serves as a tool for batch-level quality control.
Pranlukast Hydrate CoA mostly includes findings from lab analyses of a specific batch. For each Pranlukast Hydrate 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 Hydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Pranlukast Hydrate EP), Pranlukast Hydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pranlukast Hydrate USP).
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