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API SUPPLIERS
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33217
Submission : 2018-09-28
Status :
Type : II
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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 Tipiracil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tipiracil, including repackagers and relabelers. The FDA regulates Tipiracil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tipiracil 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 Tipiracil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tipiracil supplier is an individual or a company that provides Tipiracil active pharmaceutical ingredient (API) or Tipiracil finished formulations upon request. The Tipiracil suppliers may include Tipiracil API manufacturers, exporters, distributors and traders.
click here to find a list of Tipiracil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tipiracil DMF (Drug Master File) is a document detailing the whole manufacturing process of Tipiracil active pharmaceutical ingredient (API) in detail. Different forms of Tipiracil DMFs exist exist since differing nations have different regulations, such as Tipiracil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tipiracil DMF submitted to regulatory agencies in the US is known as a USDMF. Tipiracil USDMF includes data on Tipiracil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tipiracil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tipiracil 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 Tipiracil Drug Master File in Korea (Tipiracil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tipiracil. The MFDS reviews the Tipiracil KDMF as part of the drug registration process and uses the information provided in the Tipiracil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tipiracil 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 Tipiracil API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tipiracil suppliers with KDMF on PharmaCompass.
A Tipiracil written confirmation (Tipiracil WC) is an official document issued by a regulatory agency to a Tipiracil manufacturer, verifying that the manufacturing facility of a Tipiracil active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tipiracil APIs or Tipiracil finished pharmaceutical products to another nation, regulatory agencies frequently require a Tipiracil WC (written confirmation) as part of the regulatory process.
click here to find a list of Tipiracil 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 Tipiracil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tipiracil 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 Tipiracil 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 Tipiracil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tipiracil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tipiracil suppliers with NDC on PharmaCompass.
Tipiracil 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 Tipiracil 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 Tipiracil GMP manufacturer or Tipiracil GMP API supplier for your needs.
A Tipiracil CoA (Certificate of Analysis) is a formal document that attests to Tipiracil's compliance with Tipiracil specifications and serves as a tool for batch-level quality control.
Tipiracil CoA mostly includes findings from lab analyses of a specific batch. For each Tipiracil 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.
Tipiracil may be tested according to a variety of international standards, such as European Pharmacopoeia (Tipiracil EP), Tipiracil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tipiracil USP).
