API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
Other Suppliers
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
27
PharmaCompass offers a list of Mosapride Citrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Mosapride Citrate manufacturer or Mosapride Citrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mosapride Citrate manufacturer or Mosapride Citrate supplier.
PharmaCompass also assists you with knowing the Mosapride Citrate API Price utilized in the formulation of products. Mosapride Citrate API Price is not always fixed or binding as the Mosapride Citrate Price is obtained through a variety of data sources. The Mosapride Citrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Mosapride Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mosapride Citrate, including repackagers and relabelers. The FDA regulates Mosapride Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mosapride Citrate 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 Mosapride Citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mosapride Citrate supplier is an individual or a company that provides Mosapride Citrate active pharmaceutical ingredient (API) or Mosapride Citrate finished formulations upon request. The Mosapride Citrate suppliers may include Mosapride Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Mosapride Citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mosapride Citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Mosapride Citrate active pharmaceutical ingredient (API) in detail. Different forms of Mosapride Citrate DMFs exist exist since differing nations have different regulations, such as Mosapride Citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mosapride Citrate DMF submitted to regulatory agencies in the US is known as a USDMF. Mosapride Citrate USDMF includes data on Mosapride Citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mosapride Citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mosapride Citrate suppliers with USDMF 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 Mosapride Citrate Drug Master File in Japan (Mosapride Citrate JDMF) empowers Mosapride Citrate 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 Mosapride Citrate JDMF during the approval evaluation for pharmaceutical products. At the time of Mosapride Citrate 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 Mosapride Citrate 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 Mosapride Citrate Drug Master File in Korea (Mosapride Citrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mosapride Citrate. The MFDS reviews the Mosapride Citrate KDMF as part of the drug registration process and uses the information provided in the Mosapride Citrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mosapride Citrate 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 Mosapride Citrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mosapride Citrate suppliers with KDMF on PharmaCompass.
A Mosapride Citrate written confirmation (Mosapride Citrate WC) is an official document issued by a regulatory agency to a Mosapride Citrate manufacturer, verifying that the manufacturing facility of a Mosapride Citrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mosapride Citrate APIs or Mosapride Citrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Mosapride Citrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Mosapride Citrate suppliers with Written Confirmation (WC) on PharmaCompass.
Mosapride Citrate 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 Mosapride Citrate 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 Mosapride Citrate GMP manufacturer or Mosapride Citrate GMP API supplier for your needs.
A Mosapride Citrate CoA (Certificate of Analysis) is a formal document that attests to Mosapride Citrate's compliance with Mosapride Citrate specifications and serves as a tool for batch-level quality control.
Mosapride Citrate CoA mostly includes findings from lab analyses of a specific batch. For each Mosapride Citrate 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.
Mosapride Citrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Mosapride Citrate EP), Mosapride Citrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mosapride Citrate USP).