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