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