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ABOUT THIS PAGE
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PharmaCompass offers a list of Alacepril 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 Alacepril manufacturer or Alacepril supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Alacepril manufacturer or Alacepril supplier.
PharmaCompass also assists you with knowing the Alacepril API Price utilized in the formulation of products. Alacepril API Price is not always fixed or binding as the Alacepril Price is obtained through a variety of data sources. The Alacepril Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cetapril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cetapril, including repackagers and relabelers. The FDA regulates Cetapril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cetapril 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 Cetapril manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cetapril supplier is an individual or a company that provides Cetapril active pharmaceutical ingredient (API) or Cetapril finished formulations upon request. The Cetapril suppliers may include Cetapril API manufacturers, exporters, distributors and traders.
click here to find a list of Cetapril 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 Cetapril Drug Master File in Japan (Cetapril JDMF) empowers Cetapril 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 Cetapril JDMF during the approval evaluation for pharmaceutical products. At the time of Cetapril 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 Cetapril 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 Cetapril Drug Master File in Korea (Cetapril KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cetapril. The MFDS reviews the Cetapril KDMF as part of the drug registration process and uses the information provided in the Cetapril KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cetapril 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 Cetapril API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cetapril suppliers with KDMF on PharmaCompass.
Cetapril 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 Cetapril 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 Cetapril GMP manufacturer or Cetapril GMP API supplier for your needs.
A Cetapril CoA (Certificate of Analysis) is a formal document that attests to Cetapril's compliance with Cetapril specifications and serves as a tool for batch-level quality control.
Cetapril CoA mostly includes findings from lab analyses of a specific batch. For each Cetapril 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.
Cetapril may be tested according to a variety of international standards, such as European Pharmacopoeia (Cetapril EP), Cetapril JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cetapril USP).
