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