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JDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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API SUPPLIERS
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Neuland Laboratories- A dedicated 100% API provider.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Qingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.
NDC 
KDMF
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USDMF
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Dabigatran Etexilate Mesylate IH
Date of Issue : 2025-07-15
Valid Till : 2028-07-07
Written Confirmation Number : WC-0067
Address of the Firm : Chemical Technical Operation
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Dabigatran Etexilate Mesylate IH/Ph.Eur.
Date of Issue : 2024-04-03
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm : Unit-IV, Plot No: 34B, 40B & 60B, J.N. Pharma City, Thanam (V), Parawada (M), An...
Neuland Laboratories- A dedicated 100% API provider.
Dabigatran Etexilate Mesylate IH
Date of Issue : 2025-06-27
Valid Till : 2028-06-16
Written Confirmation Number : WC-0037
Address of the Firm : Unit-ll, Plot No. 92-94, 257-259, IDA Pashamylaram, Pashamylaram Village, Patanc...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Dabigatran Etexilate Mesylate IH
Date of Issue : 2025-06-04
Valid Till : 2028-05-20
Written Confirmation Number : WC-0001
Address of the Firm : Plot No. Q1 to Q4 Industrial Area, Ghirongi, Malanpur, District -Bhind (M.P.), I...
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Dabigatran Zentiva
Dosage Form : Hard Capsule
Dosage Strength : 75mg
Packaging :
Approval Date : 07/03/2024
Application Number : 68728
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Dabigatran Zentiva
Dosage Form : Hard Capsule
Dosage Strength : 110mg
Packaging :
Approval Date : 07/03/2024
Application Number : 68728
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Dabigatran Zentiva
Dosage Form : Hard Capsule
Dosage Strength : 150mg
Packaging :
Approval Date : 07/03/2024
Application Number : 68728
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Dabigatran Etexilate \"Orion\"
Dosage Form : Hard Capsules
Dosage Strength : 110mg
Packaging :
Approval Date : 18-03-2024
Application Number : 28106532720
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Dabigatran Etexilate \"Orion\"
Dosage Form : Hard Capsules
Dosage Strength : 150mg
Packaging :
Approval Date : 18-03-2024
Application Number : 28106532820
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Dabigatran Etexilate \"Orion\"
Dosage Form : Hard Capsules
Dosage Strength : 75mg
Packaging :
Approval Date : 18-03-2024
Application Number : 28106532620
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Dabigatran Etexilate Orion
Dosage Form : Capsule
Dosage Strength : 75mg
Packaging :
Approval Date : 19-12-2023
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Dabigatran Etexilate Orion
Dosage Form : Capsule
Dosage Strength : 110mg
Packaging :
Approval Date : 19-12-2023
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Dabigatran Etexilate Orion
Dosage Form : Capsule
Dosage Strength : 150mg
Packaging :
Approval Date : 19-12-2023
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info : Authorised
Registration Country : Malta
Brand Name : Sianta
Dosage Form : Hard Capsule
Dosage Strength : 75MG
Packaging :
Approval Date : 2024-01-31
Application Number :
Regulatory Info : Authorised
Registration Country : Malta
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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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Controlled & Modified Release
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Solubilizers
Emulsifying Agents
Fillers, Diluents & Binders
Vegetarian Capsules
API Stability Enhancers
Topical
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Parenteral
Direct Compression
Lubricants & Glidants
Taste Masking
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Coloring Agents
Rheology Modifiers
Chewable & Orodispersible Aids
Soft Gelatin
Disintegrants & Superdisintegrants
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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US Patents
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USP
USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.
CAS Number : 212321-78-3
Quantity Per Vial :
Price ($) : 1200
Catalog Number : 1A03730
Current Lot : 25 mg
Previous Lot :
NDC Code :
USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.
Dabigatran Etexilate Isopropyl Ester
CAS Number : 1610758-19-4
Quantity Per Vial :
Price ($) : 1200
Catalog Number : 1A03740
Current Lot : 25 mg
Previous Lot :
NDC Code :
USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.
Dabigatran Heptane-2-yl Analog
CAS Number : 1610758-21-8
Quantity Per Vial :
Price ($) : 1500
Catalog Number : 1A03750
Current Lot : 25 mg
Previous Lot :
NDC Code :
Others
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
14
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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dabigatran, including repackagers and relabelers. The FDA regulates Dabigatran manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dabigatran 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dabigatran supplier is an individual or a company that provides Dabigatran active pharmaceutical ingredient (API) or Dabigatran finished formulations upon request. The Dabigatran suppliers may include Dabigatran API manufacturers, exporters, distributors and traders.
click here to find a list of Dabigatran suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dabigatran DMF (Drug Master File) is a document detailing the whole manufacturing process of Dabigatran active pharmaceutical ingredient (API) in detail. Different forms of Dabigatran DMFs exist exist since differing nations have different regulations, such as Dabigatran USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dabigatran DMF submitted to regulatory agencies in the US is known as a USDMF. Dabigatran USDMF includes data on Dabigatran's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dabigatran USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dabigatran 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 Drug Master File in Korea (Dabigatran KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dabigatran. The MFDS reviews the Dabigatran KDMF as part of the drug registration process and uses the information provided in the Dabigatran KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dabigatran 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dabigatran suppliers with KDMF on PharmaCompass.
A Dabigatran CEP of the European Pharmacopoeia monograph is often referred to as a Dabigatran Certificate of Suitability (COS). The purpose of a Dabigatran CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dabigatran EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dabigatran to their clients by showing that a Dabigatran CEP has been issued for it. The manufacturer submits a Dabigatran CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dabigatran CEP holder for the record. Additionally, the data presented in the Dabigatran CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dabigatran DMF.
A Dabigatran CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dabigatran 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 suppliers with CEP (COS) on PharmaCompass.
A Dabigatran written confirmation (Dabigatran WC) is an official document issued by a regulatory agency to a Dabigatran manufacturer, verifying that the manufacturing facility of a Dabigatran active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dabigatran APIs or Dabigatran finished pharmaceutical products to another nation, regulatory agencies frequently require a Dabigatran WC (written confirmation) as part of the regulatory process.
click here to find a list of Dabigatran 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dabigatran 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dabigatran NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dabigatran suppliers with NDC on PharmaCompass.
Dabigatran 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 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 GMP manufacturer or Dabigatran GMP API supplier for your needs.
A Dabigatran CoA (Certificate of Analysis) is a formal document that attests to Dabigatran's compliance with Dabigatran specifications and serves as a tool for batch-level quality control.
Dabigatran CoA mostly includes findings from lab analyses of a specific batch. For each Dabigatran 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Dabigatran EP), Dabigatran JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dabigatran USP).
