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