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API SUPPLIERS
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USDMF
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Inke S.A: APIs manufacturing plant.
About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in...
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DOSAGE - TABLET;ORAL - EQ 10MG BASE
USFDA APPLICATION NUMBER - 22307
DOSAGE - TABLET;ORAL - EQ 5MG BASE
USFDA APPLICATION NUMBER - 22307
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PharmaCompass offers a list of Prasugrel 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 Prasugrel Hydrochloride manufacturer or Prasugrel Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Prasugrel Hydrochloride manufacturer or Prasugrel Hydrochloride supplier.
PharmaCompass also assists you with knowing the Prasugrel Hydrochloride API Price utilized in the formulation of products. Prasugrel Hydrochloride API Price is not always fixed or binding as the Prasugrel Hydrochloride Price is obtained through a variety of data sources. The Prasugrel Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Prasugrel HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prasugrel HCl, including repackagers and relabelers. The FDA regulates Prasugrel HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prasugrel HCl 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 Prasugrel HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prasugrel HCl supplier is an individual or a company that provides Prasugrel HCl active pharmaceutical ingredient (API) or Prasugrel HCl finished formulations upon request. The Prasugrel HCl suppliers may include Prasugrel HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Prasugrel HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prasugrel HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Prasugrel HCl active pharmaceutical ingredient (API) in detail. Different forms of Prasugrel HCl DMFs exist exist since differing nations have different regulations, such as Prasugrel HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prasugrel HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Prasugrel HCl USDMF includes data on Prasugrel HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prasugrel HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prasugrel HCl 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 Prasugrel HCl Drug Master File in Japan (Prasugrel HCl JDMF) empowers Prasugrel HCl 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 Prasugrel HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Prasugrel HCl 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 Prasugrel HCl 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 Prasugrel HCl Drug Master File in Korea (Prasugrel HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Prasugrel HCl. The MFDS reviews the Prasugrel HCl KDMF as part of the drug registration process and uses the information provided in the Prasugrel HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Prasugrel HCl 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 Prasugrel HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Prasugrel HCl suppliers with KDMF on PharmaCompass.
A Prasugrel HCl CEP of the European Pharmacopoeia monograph is often referred to as a Prasugrel HCl Certificate of Suitability (COS). The purpose of a Prasugrel HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Prasugrel HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Prasugrel HCl to their clients by showing that a Prasugrel HCl CEP has been issued for it. The manufacturer submits a Prasugrel HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Prasugrel HCl CEP holder for the record. Additionally, the data presented in the Prasugrel HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Prasugrel HCl DMF.
A Prasugrel HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Prasugrel HCl CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Prasugrel HCl suppliers with CEP (COS) on PharmaCompass.
A Prasugrel HCl written confirmation (Prasugrel HCl WC) is an official document issued by a regulatory agency to a Prasugrel HCl manufacturer, verifying that the manufacturing facility of a Prasugrel HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Prasugrel HCl APIs or Prasugrel HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Prasugrel HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Prasugrel HCl 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 Prasugrel HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Prasugrel HCl 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 Prasugrel HCl 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 Prasugrel HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Prasugrel HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Prasugrel HCl suppliers with NDC on PharmaCompass.
Prasugrel HCl 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 Prasugrel HCl 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 Prasugrel HCl GMP manufacturer or Prasugrel HCl GMP API supplier for your needs.
A Prasugrel HCl CoA (Certificate of Analysis) is a formal document that attests to Prasugrel HCl's compliance with Prasugrel HCl specifications and serves as a tool for batch-level quality control.
Prasugrel HCl CoA mostly includes findings from lab analyses of a specific batch. For each Prasugrel HCl 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.
Prasugrel HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Prasugrel HCl EP), Prasugrel HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Prasugrel HCl USP).
