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ABOUT THIS PAGE
A Cilazapril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cilazapril, including repackagers and relabelers. The FDA regulates Cilazapril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cilazapril 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 Cilazapril manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cilazapril supplier is an individual or a company that provides Cilazapril active pharmaceutical ingredient (API) or Cilazapril finished formulations upon request. The Cilazapril suppliers may include Cilazapril API manufacturers, exporters, distributors and traders.
click here to find a list of Cilazapril 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 Cilazapril Drug Master File in Japan (Cilazapril JDMF) empowers Cilazapril 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 Cilazapril JDMF during the approval evaluation for pharmaceutical products. At the time of Cilazapril 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 Cilazapril 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 Cilazapril Drug Master File in Korea (Cilazapril KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cilazapril. The MFDS reviews the Cilazapril KDMF as part of the drug registration process and uses the information provided in the Cilazapril KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cilazapril 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 Cilazapril API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cilazapril suppliers with KDMF on PharmaCompass.
A Cilazapril CEP of the European Pharmacopoeia monograph is often referred to as a Cilazapril Certificate of Suitability (COS). The purpose of a Cilazapril CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cilazapril EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cilazapril to their clients by showing that a Cilazapril CEP has been issued for it. The manufacturer submits a Cilazapril CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cilazapril CEP holder for the record. Additionally, the data presented in the Cilazapril CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cilazapril DMF.
A Cilazapril CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cilazapril CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Cilazapril suppliers with CEP (COS) on PharmaCompass.
A Cilazapril written confirmation (Cilazapril WC) is an official document issued by a regulatory agency to a Cilazapril manufacturer, verifying that the manufacturing facility of a Cilazapril active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cilazapril APIs or Cilazapril finished pharmaceutical products to another nation, regulatory agencies frequently require a Cilazapril WC (written confirmation) as part of the regulatory process.
click here to find a list of Cilazapril suppliers with Written Confirmation (WC) on PharmaCompass.
Cilazapril 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 Cilazapril 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 Cilazapril GMP manufacturer or Cilazapril GMP API supplier for your needs.
A Cilazapril CoA (Certificate of Analysis) is a formal document that attests to Cilazapril's compliance with Cilazapril specifications and serves as a tool for batch-level quality control.
Cilazapril CoA mostly includes findings from lab analyses of a specific batch. For each Cilazapril 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.
Cilazapril may be tested according to a variety of international standards, such as European Pharmacopoeia (Cilazapril EP), Cilazapril JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cilazapril USP).
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