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