API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
0
EU WC
Listed Suppliers
USA (Orange Book)
Europe
Canada
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
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PharmaCompass offers a list of Lopinavir 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 Lopinavir manufacturer or Lopinavir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lopinavir manufacturer or Lopinavir supplier.
PharmaCompass also assists you with knowing the Lopinavir API Price utilized in the formulation of products. Lopinavir API Price is not always fixed or binding as the Lopinavir Price is obtained through a variety of data sources. The Lopinavir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lopinavir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lopinavir, including repackagers and relabelers. The FDA regulates Lopinavir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lopinavir 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 Lopinavir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lopinavir supplier is an individual or a company that provides Lopinavir active pharmaceutical ingredient (API) or Lopinavir finished formulations upon request. The Lopinavir suppliers may include Lopinavir API manufacturers, exporters, distributors and traders.
click here to find a list of Lopinavir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lopinavir DMF (Drug Master File) is a document detailing the whole manufacturing process of Lopinavir active pharmaceutical ingredient (API) in detail. Different forms of Lopinavir DMFs exist exist since differing nations have different regulations, such as Lopinavir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lopinavir DMF submitted to regulatory agencies in the US is known as a USDMF. Lopinavir USDMF includes data on Lopinavir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lopinavir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lopinavir suppliers with USDMF 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 Lopinavir Drug Master File in Korea (Lopinavir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lopinavir. The MFDS reviews the Lopinavir KDMF as part of the drug registration process and uses the information provided in the Lopinavir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lopinavir 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 Lopinavir API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lopinavir suppliers with KDMF on PharmaCompass.
A Lopinavir CEP of the European Pharmacopoeia monograph is often referred to as a Lopinavir Certificate of Suitability (COS). The purpose of a Lopinavir CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lopinavir EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lopinavir to their clients by showing that a Lopinavir CEP has been issued for it. The manufacturer submits a Lopinavir CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lopinavir CEP holder for the record. Additionally, the data presented in the Lopinavir CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lopinavir DMF.
A Lopinavir CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lopinavir 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 Lopinavir suppliers with CEP (COS) on PharmaCompass.
A Lopinavir written confirmation (Lopinavir WC) is an official document issued by a regulatory agency to a Lopinavir manufacturer, verifying that the manufacturing facility of a Lopinavir active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lopinavir APIs or Lopinavir finished pharmaceutical products to another nation, regulatory agencies frequently require a Lopinavir WC (written confirmation) as part of the regulatory process.
click here to find a list of Lopinavir 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 Lopinavir as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lopinavir 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 Lopinavir 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 Lopinavir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lopinavir NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lopinavir suppliers with NDC on PharmaCompass.
Lopinavir 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 Lopinavir 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 Lopinavir GMP manufacturer or Lopinavir GMP API supplier for your needs.
A Lopinavir CoA (Certificate of Analysis) is a formal document that attests to Lopinavir's compliance with Lopinavir specifications and serves as a tool for batch-level quality control.
Lopinavir CoA mostly includes findings from lab analyses of a specific batch. For each Lopinavir 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.
Lopinavir may be tested according to a variety of international standards, such as European Pharmacopoeia (Lopinavir EP), Lopinavir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lopinavir USP).