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