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PharmaCompass offers a list of Cilnidipine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Cilnidipine manufacturer or Cilnidipine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cilnidipine manufacturer or Cilnidipine supplier.
A Atelec manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Atelec, including repackagers and relabelers. The FDA regulates Atelec manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Atelec 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 Atelec manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Atelec supplier is an individual or a company that provides Atelec active pharmaceutical ingredient (API) or Atelec finished formulations upon request. The Atelec suppliers may include Atelec API manufacturers, exporters, distributors and traders.
click here to find a list of Atelec suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Atelec DMF (Drug Master File) is a document detailing the whole manufacturing process of Atelec active pharmaceutical ingredient (API) in detail. Different forms of Atelec DMFs exist exist since differing nations have different regulations, such as Atelec USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Atelec DMF submitted to regulatory agencies in the US is known as a USDMF. Atelec USDMF includes data on Atelec's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Atelec USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Atelec 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 Atelec Drug Master File in Japan (Atelec JDMF) empowers Atelec 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 Atelec JDMF during the approval evaluation for pharmaceutical products. At the time of Atelec 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 Atelec 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 Atelec Drug Master File in Korea (Atelec KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Atelec. The MFDS reviews the Atelec KDMF as part of the drug registration process and uses the information provided in the Atelec KDMF to evaluate the safety and efficacy of the drug.
After submitting a Atelec 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 Atelec API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Atelec suppliers with KDMF on PharmaCompass.
A Atelec written confirmation (Atelec WC) is an official document issued by a regulatory agency to a Atelec manufacturer, verifying that the manufacturing facility of a Atelec active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Atelec APIs or Atelec finished pharmaceutical products to another nation, regulatory agencies frequently require a Atelec WC (written confirmation) as part of the regulatory process.
click here to find a list of Atelec suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Atelec as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Atelec API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Atelec as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Atelec and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Atelec NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Atelec suppliers with NDC on PharmaCompass.
Atelec 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 Atelec GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Atelec GMP manufacturer or Atelec GMP API supplier for your needs.
A Atelec CoA (Certificate of Analysis) is a formal document that attests to Atelec's compliance with Atelec specifications and serves as a tool for batch-level quality control.
Atelec CoA mostly includes findings from lab analyses of a specific batch. For each Atelec 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.
Atelec may be tested according to a variety of international standards, such as European Pharmacopoeia (Atelec EP), Atelec JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Atelec USP).
