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