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PharmaCompass offers a list of Enalapril Maleate 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 Enalapril Maleate manufacturer or Enalapril Maleate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Enalapril Maleate manufacturer or Enalapril Maleate supplier.
PharmaCompass also assists you with knowing the Enalapril Maleate API Price utilized in the formulation of products. Enalapril Maleate API Price is not always fixed or binding as the Enalapril Maleate Price is obtained through a variety of data sources. The Enalapril Maleate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Enalapril Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Enalapril Maleate, including repackagers and relabelers. The FDA regulates Enalapril Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Enalapril Maleate 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 Enalapril Maleate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Enalapril Maleate supplier is an individual or a company that provides Enalapril Maleate active pharmaceutical ingredient (API) or Enalapril Maleate finished formulations upon request. The Enalapril Maleate suppliers may include Enalapril Maleate API manufacturers, exporters, distributors and traders.
click here to find a list of Enalapril Maleate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Enalapril Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Enalapril Maleate active pharmaceutical ingredient (API) in detail. Different forms of Enalapril Maleate DMFs exist exist since differing nations have different regulations, such as Enalapril Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Enalapril Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Enalapril Maleate USDMF includes data on Enalapril Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Enalapril Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Enalapril Maleate 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 Enalapril Maleate Drug Master File in Japan (Enalapril Maleate JDMF) empowers Enalapril Maleate 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 Enalapril Maleate JDMF during the approval evaluation for pharmaceutical products. At the time of Enalapril Maleate 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 Enalapril Maleate 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 Enalapril Maleate Drug Master File in Korea (Enalapril Maleate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Enalapril Maleate. The MFDS reviews the Enalapril Maleate KDMF as part of the drug registration process and uses the information provided in the Enalapril Maleate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Enalapril Maleate 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 Enalapril Maleate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Enalapril Maleate suppliers with KDMF on PharmaCompass.
A Enalapril Maleate CEP of the European Pharmacopoeia monograph is often referred to as a Enalapril Maleate Certificate of Suitability (COS). The purpose of a Enalapril Maleate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Enalapril Maleate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Enalapril Maleate to their clients by showing that a Enalapril Maleate CEP has been issued for it. The manufacturer submits a Enalapril Maleate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Enalapril Maleate CEP holder for the record. Additionally, the data presented in the Enalapril Maleate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Enalapril Maleate DMF.
A Enalapril Maleate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Enalapril Maleate 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 Enalapril Maleate suppliers with CEP (COS) on PharmaCompass.
A Enalapril Maleate written confirmation (Enalapril Maleate WC) is an official document issued by a regulatory agency to a Enalapril Maleate manufacturer, verifying that the manufacturing facility of a Enalapril Maleate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Enalapril Maleate APIs or Enalapril Maleate finished pharmaceutical products to another nation, regulatory agencies frequently require a Enalapril Maleate WC (written confirmation) as part of the regulatory process.
click here to find a list of Enalapril Maleate suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Enalapril Maleate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Enalapril Maleate API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Enalapril Maleate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Enalapril Maleate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Enalapril Maleate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Enalapril Maleate suppliers with NDC on PharmaCompass.
Enalapril Maleate 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 Enalapril Maleate 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 Enalapril Maleate GMP manufacturer or Enalapril Maleate GMP API supplier for your needs.
A Enalapril Maleate CoA (Certificate of Analysis) is a formal document that attests to Enalapril Maleate's compliance with Enalapril Maleate specifications and serves as a tool for batch-level quality control.
Enalapril Maleate CoA mostly includes findings from lab analyses of a specific batch. For each Enalapril Maleate 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.
Enalapril Maleate may be tested according to a variety of international standards, such as European Pharmacopoeia (Enalapril Maleate EP), Enalapril Maleate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Enalapril Maleate USP).