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