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