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