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ABOUT THIS PAGE
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PharmaCompass offers a list of Tipiracil 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 Tipiracil Hydrochloride manufacturer or Tipiracil Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tipiracil Hydrochloride manufacturer or Tipiracil Hydrochloride supplier.
PharmaCompass also assists you with knowing the Tipiracil Hydrochloride API Price utilized in the formulation of products. Tipiracil Hydrochloride API Price is not always fixed or binding as the Tipiracil Hydrochloride Price is obtained through a variety of data sources. The Tipiracil Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A TAS-1-462 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TAS-1-462, including repackagers and relabelers. The FDA regulates TAS-1-462 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TAS-1-462 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 TAS-1-462 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A TAS-1-462 supplier is an individual or a company that provides TAS-1-462 active pharmaceutical ingredient (API) or TAS-1-462 finished formulations upon request. The TAS-1-462 suppliers may include TAS-1-462 API manufacturers, exporters, distributors and traders.
click here to find a list of TAS-1-462 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A TAS-1-462 DMF (Drug Master File) is a document detailing the whole manufacturing process of TAS-1-462 active pharmaceutical ingredient (API) in detail. Different forms of TAS-1-462 DMFs exist exist since differing nations have different regulations, such as TAS-1-462 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A TAS-1-462 DMF submitted to regulatory agencies in the US is known as a USDMF. TAS-1-462 USDMF includes data on TAS-1-462's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TAS-1-462 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of TAS-1-462 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 TAS-1-462 Drug Master File in Korea (TAS-1-462 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of TAS-1-462. The MFDS reviews the TAS-1-462 KDMF as part of the drug registration process and uses the information provided in the TAS-1-462 KDMF to evaluate the safety and efficacy of the drug.
After submitting a TAS-1-462 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 TAS-1-462 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of TAS-1-462 suppliers with KDMF on PharmaCompass.
A TAS-1-462 written confirmation (TAS-1-462 WC) is an official document issued by a regulatory agency to a TAS-1-462 manufacturer, verifying that the manufacturing facility of a TAS-1-462 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting TAS-1-462 APIs or TAS-1-462 finished pharmaceutical products to another nation, regulatory agencies frequently require a TAS-1-462 WC (written confirmation) as part of the regulatory process.
click here to find a list of TAS-1-462 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 TAS-1-462 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for TAS-1-462 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 TAS-1-462 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 TAS-1-462 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a TAS-1-462 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of TAS-1-462 suppliers with NDC on PharmaCompass.
TAS-1-462 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 TAS-1-462 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 TAS-1-462 GMP manufacturer or TAS-1-462 GMP API supplier for your needs.
A TAS-1-462 CoA (Certificate of Analysis) is a formal document that attests to TAS-1-462's compliance with TAS-1-462 specifications and serves as a tool for batch-level quality control.
TAS-1-462 CoA mostly includes findings from lab analyses of a specific batch. For each TAS-1-462 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.
TAS-1-462 may be tested according to a variety of international standards, such as European Pharmacopoeia (TAS-1-462 EP), TAS-1-462 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (TAS-1-462 USP).
