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API SUPPLIERS
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USDMF
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-30
Pay. Date : 2013-04-09
DMF Number : 27048
Submission : 2013-06-12
Status :
Type : II
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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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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Prasugrel Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prasugrel Hydrochloride, including repackagers and relabelers. The FDA regulates Prasugrel Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prasugrel Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prasugrel Hydrochloride supplier is an individual or a company that provides Prasugrel Hydrochloride active pharmaceutical ingredient (API) or Prasugrel Hydrochloride finished formulations upon request. The Prasugrel Hydrochloride suppliers may include Prasugrel Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Prasugrel Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prasugrel Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Prasugrel Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Prasugrel Hydrochloride DMFs exist exist since differing nations have different regulations, such as Prasugrel Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prasugrel Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Prasugrel Hydrochloride USDMF includes data on Prasugrel Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prasugrel Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prasugrel Hydrochloride 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 Prasugrel Hydrochloride Drug Master File in Korea (Prasugrel Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Prasugrel Hydrochloride. The MFDS reviews the Prasugrel Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Prasugrel Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Prasugrel Hydrochloride 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 Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Prasugrel Hydrochloride suppliers with KDMF on PharmaCompass.
A Prasugrel Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Prasugrel Hydrochloride Certificate of Suitability (COS). The purpose of a Prasugrel Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Prasugrel Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Prasugrel Hydrochloride to their clients by showing that a Prasugrel Hydrochloride CEP has been issued for it. The manufacturer submits a Prasugrel Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Prasugrel Hydrochloride CEP holder for the record. Additionally, the data presented in the Prasugrel Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Prasugrel Hydrochloride DMF.
A Prasugrel Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Prasugrel Hydrochloride 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 Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Prasugrel Hydrochloride written confirmation (Prasugrel Hydrochloride WC) is an official document issued by a regulatory agency to a Prasugrel Hydrochloride manufacturer, verifying that the manufacturing facility of a Prasugrel Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Prasugrel Hydrochloride APIs or Prasugrel Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Prasugrel Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Prasugrel Hydrochloride 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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Prasugrel Hydrochloride 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 Hydrochloride 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 Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Prasugrel Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Prasugrel Hydrochloride suppliers with NDC on PharmaCompass.
Prasugrel Hydrochloride 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 Hydrochloride 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 Hydrochloride GMP manufacturer or Prasugrel Hydrochloride GMP API supplier for your needs.
A Prasugrel Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Prasugrel Hydrochloride's compliance with Prasugrel Hydrochloride specifications and serves as a tool for batch-level quality control.
Prasugrel Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Prasugrel Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Prasugrel Hydrochloride EP), Prasugrel Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Prasugrel Hydrochloride USP).
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