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