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