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API SUPPLIERS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Maithri Drugs: Dedicated to your API needs.
Maithri Drugs: Dedicated to your API needs.
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USDMF
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Maithri Drugs: Dedicated to your API needs.
Lercanidipine Hydrochloride, Crystalline Form I
Certificate Number : CEP 2024-503 - Rev 00
Status : Valid
Issue Date : 2025-12-16
Type : Chemical
Substance Number : 3052
Maithri Drugs: Dedicated to your API needs.
Lercanidipine Hydrochloride, Amorphous
Certificate Number : CEP 2024-409 - Rev 00
Status : Valid
Issue Date : 2025-12-04
Type : Chemical
Substance Number : 3052
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PharmaCompass offers a list of Lercanidipine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Lercanidipine Hydrochloride manufacturer or Lercanidipine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lercanidipine Hydrochloride manufacturer or Lercanidipine Hydrochloride supplier.
A Cardiovasc manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cardiovasc, including repackagers and relabelers. The FDA regulates Cardiovasc manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cardiovasc 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 Cardiovasc manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Cardiovasc supplier is an individual or a company that provides Cardiovasc active pharmaceutical ingredient (API) or Cardiovasc finished formulations upon request. The Cardiovasc suppliers may include Cardiovasc API manufacturers, exporters, distributors and traders.
click here to find a list of Cardiovasc suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Cardiovasc DMF (Drug Master File) is a document detailing the whole manufacturing process of Cardiovasc active pharmaceutical ingredient (API) in detail. Different forms of Cardiovasc DMFs exist exist since differing nations have different regulations, such as Cardiovasc USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cardiovasc DMF submitted to regulatory agencies in the US is known as a USDMF. Cardiovasc USDMF includes data on Cardiovasc's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cardiovasc USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cardiovasc 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 Cardiovasc Drug Master File in Korea (Cardiovasc KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cardiovasc. The MFDS reviews the Cardiovasc KDMF as part of the drug registration process and uses the information provided in the Cardiovasc KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cardiovasc 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 Cardiovasc API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cardiovasc suppliers with KDMF on PharmaCompass.
A Cardiovasc CEP of the European Pharmacopoeia monograph is often referred to as a Cardiovasc Certificate of Suitability (COS). The purpose of a Cardiovasc CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cardiovasc EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cardiovasc to their clients by showing that a Cardiovasc CEP has been issued for it. The manufacturer submits a Cardiovasc CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cardiovasc CEP holder for the record. Additionally, the data presented in the Cardiovasc CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cardiovasc DMF.
A Cardiovasc CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cardiovasc 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 Cardiovasc suppliers with CEP (COS) on PharmaCompass.
A Cardiovasc written confirmation (Cardiovasc WC) is an official document issued by a regulatory agency to a Cardiovasc manufacturer, verifying that the manufacturing facility of a Cardiovasc active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cardiovasc APIs or Cardiovasc finished pharmaceutical products to another nation, regulatory agencies frequently require a Cardiovasc WC (written confirmation) as part of the regulatory process.
click here to find a list of Cardiovasc 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 Cardiovasc as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cardiovasc 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 Cardiovasc 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 Cardiovasc and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cardiovasc NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cardiovasc suppliers with NDC on PharmaCompass.
Cardiovasc 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 Cardiovasc GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Cardiovasc GMP manufacturer or Cardiovasc GMP API supplier for your needs.
A Cardiovasc CoA (Certificate of Analysis) is a formal document that attests to Cardiovasc's compliance with Cardiovasc specifications and serves as a tool for batch-level quality control.
Cardiovasc CoA mostly includes findings from lab analyses of a specific batch. For each Cardiovasc 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.
Cardiovasc may be tested according to a variety of international standards, such as European Pharmacopoeia (Cardiovasc EP), Cardiovasc JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cardiovasc USP).
