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ABOUT THIS PAGE
A Amlodipine Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amlodipine Maleate, including repackagers and relabelers. The FDA regulates Amlodipine Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amlodipine Maleate 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 Amlodipine Maleate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amlodipine Maleate supplier is an individual or a company that provides Amlodipine Maleate active pharmaceutical ingredient (API) or Amlodipine Maleate finished formulations upon request. The Amlodipine Maleate suppliers may include Amlodipine Maleate API manufacturers, exporters, distributors and traders.
click here to find a list of Amlodipine Maleate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amlodipine Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Amlodipine Maleate active pharmaceutical ingredient (API) in detail. Different forms of Amlodipine Maleate DMFs exist exist since differing nations have different regulations, such as Amlodipine Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amlodipine Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Amlodipine Maleate USDMF includes data on Amlodipine Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amlodipine Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amlodipine Maleate 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 Amlodipine Maleate Drug Master File in Korea (Amlodipine Maleate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Amlodipine Maleate. The MFDS reviews the Amlodipine Maleate KDMF as part of the drug registration process and uses the information provided in the Amlodipine Maleate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Amlodipine Maleate 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 Amlodipine Maleate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Amlodipine Maleate suppliers with KDMF on PharmaCompass.
A Amlodipine Maleate written confirmation (Amlodipine Maleate WC) is an official document issued by a regulatory agency to a Amlodipine Maleate manufacturer, verifying that the manufacturing facility of a Amlodipine Maleate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Amlodipine Maleate APIs or Amlodipine Maleate finished pharmaceutical products to another nation, regulatory agencies frequently require a Amlodipine Maleate WC (written confirmation) as part of the regulatory process.
click here to find a list of Amlodipine Maleate suppliers with Written Confirmation (WC) on PharmaCompass.
Amlodipine Maleate 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 Amlodipine Maleate 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 Amlodipine Maleate GMP manufacturer or Amlodipine Maleate GMP API supplier for your needs.
A Amlodipine Maleate CoA (Certificate of Analysis) is a formal document that attests to Amlodipine Maleate's compliance with Amlodipine Maleate specifications and serves as a tool for batch-level quality control.
Amlodipine Maleate CoA mostly includes findings from lab analyses of a specific batch. For each Amlodipine Maleate 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.
Amlodipine Maleate may be tested according to a variety of international standards, such as European Pharmacopoeia (Amlodipine Maleate EP), Amlodipine Maleate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Amlodipine Maleate USP).
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