X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
Other Suppliers
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
0
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
38
PharmaCompass offers a list of Imidapril 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 Imidapril manufacturer or Imidapril supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Imidapril manufacturer or Imidapril supplier.
PharmaCompass also assists you with knowing the Imidapril API Price utilized in the formulation of products. Imidapril API Price is not always fixed or binding as the Imidapril Price is obtained through a variety of data sources. The Imidapril Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Imidapril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Imidapril, including repackagers and relabelers. The FDA regulates Imidapril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Imidapril 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 Imidapril manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Imidapril supplier is an individual or a company that provides Imidapril active pharmaceutical ingredient (API) or Imidapril finished formulations upon request. The Imidapril suppliers may include Imidapril API manufacturers, exporters, distributors and traders.
click here to find a list of Imidapril suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Imidapril DMF (Drug Master File) is a document detailing the whole manufacturing process of Imidapril active pharmaceutical ingredient (API) in detail. Different forms of Imidapril DMFs exist exist since differing nations have different regulations, such as Imidapril USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Imidapril DMF submitted to regulatory agencies in the US is known as a USDMF. Imidapril USDMF includes data on Imidapril's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Imidapril USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Imidapril 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 Imidapril Drug Master File in Japan (Imidapril JDMF) empowers Imidapril 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 Imidapril JDMF during the approval evaluation for pharmaceutical products. At the time of Imidapril 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 Imidapril 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 Imidapril Drug Master File in Korea (Imidapril KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Imidapril. The MFDS reviews the Imidapril KDMF as part of the drug registration process and uses the information provided in the Imidapril KDMF to evaluate the safety and efficacy of the drug.
After submitting a Imidapril 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 Imidapril API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Imidapril suppliers with KDMF on PharmaCompass.
A Imidapril written confirmation (Imidapril WC) is an official document issued by a regulatory agency to a Imidapril manufacturer, verifying that the manufacturing facility of a Imidapril active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Imidapril APIs or Imidapril finished pharmaceutical products to another nation, regulatory agencies frequently require a Imidapril WC (written confirmation) as part of the regulatory process.
click here to find a list of Imidapril suppliers with Written Confirmation (WC) on PharmaCompass.
Imidapril 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 Imidapril 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 Imidapril GMP manufacturer or Imidapril GMP API supplier for your needs.
A Imidapril CoA (Certificate of Analysis) is a formal document that attests to Imidapril's compliance with Imidapril specifications and serves as a tool for batch-level quality control.
Imidapril CoA mostly includes findings from lab analyses of a specific batch. For each Imidapril 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.
Imidapril may be tested according to a variety of international standards, such as European Pharmacopoeia (Imidapril EP), Imidapril JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Imidapril USP).
Market Place
