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