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