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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product ...
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ABOUT THIS PAGE
A Manidipine Dihydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Manidipine Dihydrochloride, including repackagers and relabelers. The FDA regulates Manidipine Dihydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Manidipine Dihydrochloride 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 Dihydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Manidipine Dihydrochloride supplier is an individual or a company that provides Manidipine Dihydrochloride active pharmaceutical ingredient (API) or Manidipine Dihydrochloride finished formulations upon request. The Manidipine Dihydrochloride suppliers may include Manidipine Dihydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Manidipine Dihydrochloride 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 Dihydrochloride Drug Master File in Japan (Manidipine Dihydrochloride JDMF) empowers Manidipine Dihydrochloride 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 Dihydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Manidipine Dihydrochloride 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 Dihydrochloride 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 Dihydrochloride Drug Master File in Korea (Manidipine Dihydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Manidipine Dihydrochloride. The MFDS reviews the Manidipine Dihydrochloride KDMF as part of the drug registration process and uses the information provided in the Manidipine Dihydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Manidipine Dihydrochloride 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 Dihydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Manidipine Dihydrochloride suppliers with KDMF on PharmaCompass.
A Manidipine Dihydrochloride written confirmation (Manidipine Dihydrochloride WC) is an official document issued by a regulatory agency to a Manidipine Dihydrochloride manufacturer, verifying that the manufacturing facility of a Manidipine Dihydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Manidipine Dihydrochloride APIs or Manidipine Dihydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Manidipine Dihydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Manidipine Dihydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.
Manidipine Dihydrochloride 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 Dihydrochloride 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 Dihydrochloride GMP manufacturer or Manidipine Dihydrochloride GMP API supplier for your needs.
A Manidipine Dihydrochloride CoA (Certificate of Analysis) is a formal document that attests to Manidipine Dihydrochloride's compliance with Manidipine Dihydrochloride specifications and serves as a tool for batch-level quality control.
Manidipine Dihydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Manidipine Dihydrochloride 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 Dihydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Manidipine Dihydrochloride EP), Manidipine Dihydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Manidipine Dihydrochloride USP).
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