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Drugs in Development
Lead Product(s) : Dabigatran Etexilate Mesylate,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Dabigatran Etexilate Capsules (generic for Pradaxa®), is good at preventing blood clots that can cause a stroke or heart attack, but it can be very expensive and must be used carefully in patients with kidney problems.
Product Name : Dabigatran Etexilate-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 22, 2022
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DOSAGE - CAPSULE;ORAL - EQ 110MG BASE
USFDA APPLICATION NUMBER - 22512
DOSAGE - CAPSULE;ORAL - EQ 150MG BASE
USFDA APPLICATION NUMBER - 22512
DOSAGE - CAPSULE;ORAL - EQ 75MG BASE
USFDA APPLICATION NUMBER - 22512
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PharmaCompass offers a list of Dabigatran Etexilate Mesylate 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 Dabigatran Etexilate Mesylate manufacturer or Dabigatran Etexilate Mesylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dabigatran Etexilate Mesylate manufacturer or Dabigatran Etexilate Mesylate supplier.
PharmaCompass also assists you with knowing the Dabigatran Etexilate Mesylate API Price utilized in the formulation of products. Dabigatran Etexilate Mesylate API Price is not always fixed or binding as the Dabigatran Etexilate Mesylate Price is obtained through a variety of data sources. The Dabigatran Etexilate Mesylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dabigatran Etexilate Mesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dabigatran Etexilate Mesylate, including repackagers and relabelers. The FDA regulates Dabigatran Etexilate Mesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dabigatran Etexilate Mesylate 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 Dabigatran Etexilate Mesylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dabigatran Etexilate Mesylate supplier is an individual or a company that provides Dabigatran Etexilate Mesylate active pharmaceutical ingredient (API) or Dabigatran Etexilate Mesylate finished formulations upon request. The Dabigatran Etexilate Mesylate suppliers may include Dabigatran Etexilate Mesylate API manufacturers, exporters, distributors and traders.
click here to find a list of Dabigatran Etexilate Mesylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dabigatran Etexilate Mesylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Dabigatran Etexilate Mesylate active pharmaceutical ingredient (API) in detail. Different forms of Dabigatran Etexilate Mesylate DMFs exist exist since differing nations have different regulations, such as Dabigatran Etexilate Mesylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dabigatran Etexilate Mesylate DMF submitted to regulatory agencies in the US is known as a USDMF. Dabigatran Etexilate Mesylate USDMF includes data on Dabigatran Etexilate Mesylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dabigatran Etexilate Mesylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dabigatran Etexilate Mesylate 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 Dabigatran Etexilate Mesylate Drug Master File in Korea (Dabigatran Etexilate Mesylate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dabigatran Etexilate Mesylate. The MFDS reviews the Dabigatran Etexilate Mesylate KDMF as part of the drug registration process and uses the information provided in the Dabigatran Etexilate Mesylate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dabigatran Etexilate Mesylate 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 Dabigatran Etexilate Mesylate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dabigatran Etexilate Mesylate suppliers with KDMF on PharmaCompass.
A Dabigatran Etexilate Mesylate CEP of the European Pharmacopoeia monograph is often referred to as a Dabigatran Etexilate Mesylate Certificate of Suitability (COS). The purpose of a Dabigatran Etexilate Mesylate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dabigatran Etexilate Mesylate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dabigatran Etexilate Mesylate to their clients by showing that a Dabigatran Etexilate Mesylate CEP has been issued for it. The manufacturer submits a Dabigatran Etexilate Mesylate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dabigatran Etexilate Mesylate CEP holder for the record. Additionally, the data presented in the Dabigatran Etexilate Mesylate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dabigatran Etexilate Mesylate DMF.
A Dabigatran Etexilate Mesylate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dabigatran Etexilate Mesylate 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 Dabigatran Etexilate Mesylate suppliers with CEP (COS) on PharmaCompass.
A Dabigatran Etexilate Mesylate written confirmation (Dabigatran Etexilate Mesylate WC) is an official document issued by a regulatory agency to a Dabigatran Etexilate Mesylate manufacturer, verifying that the manufacturing facility of a Dabigatran Etexilate Mesylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dabigatran Etexilate Mesylate APIs or Dabigatran Etexilate Mesylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Dabigatran Etexilate Mesylate WC (written confirmation) as part of the regulatory process.
click here to find a list of Dabigatran Etexilate Mesylate 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 Dabigatran Etexilate Mesylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dabigatran Etexilate Mesylate 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 Dabigatran Etexilate Mesylate 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 Dabigatran Etexilate Mesylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dabigatran Etexilate Mesylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dabigatran Etexilate Mesylate suppliers with NDC on PharmaCompass.
Dabigatran Etexilate Mesylate 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 Dabigatran Etexilate Mesylate 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 Dabigatran Etexilate Mesylate GMP manufacturer or Dabigatran Etexilate Mesylate GMP API supplier for your needs.
A Dabigatran Etexilate Mesylate CoA (Certificate of Analysis) is a formal document that attests to Dabigatran Etexilate Mesylate's compliance with Dabigatran Etexilate Mesylate specifications and serves as a tool for batch-level quality control.
Dabigatran Etexilate Mesylate CoA mostly includes findings from lab analyses of a specific batch. For each Dabigatran Etexilate Mesylate 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.
Dabigatran Etexilate Mesylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Dabigatran Etexilate Mesylate EP), Dabigatran Etexilate Mesylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dabigatran Etexilate Mesylate USP).
