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