Synopsis
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JDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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.
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USDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2025-07-20
Pay. Date : 2025-06-23
DMF Number : 40568
Submission : 2024-09-30
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-07
Pay. Date : 2014-04-21
DMF Number : 27960
Submission : 2014-04-04
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37633
Submission : 2022-10-31
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38769
Submission : 2025-03-28
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28352
Submission : 2014-07-07
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-15
Pay. Date : 2014-04-22
DMF Number : 28118
Submission : 2014-04-27
Status :
Type : II
Qingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36539
Submission : 2021-12-29
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Certificate Number : CEP 2024-130 - Rev 00
Status : Valid
Issue Date : 2026-01-22
Type : Chemical
Substance Number : 3095
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Dabigatran Etexilate Mesilate, Form I, ACL
Certificate Number : CEP 2025-606 - Rev 00
Status : Valid
Issue Date : 2026-03-11
Type : Chemical
Substance Number : 3095
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Dabigatran Etexilate Mesilate, Form I
Certificate Number : CEP 2024-114 - Rev 01
Status : Valid
Issue Date : 2025-03-20
Type : Chemical
Substance Number : 3095
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
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...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : Sangjin Trading Co., Ltd.
Registration Date : 2021-07-05
Registration Number : Su583-29-ND
Manufacturer Name : Dr. Reddy's Laboratories Lim...
Manufacturer Address : CTD-VI, APIIC Industrial Estate, Pydhibeemavaram, Ranasthalam Mandal, Srikakulam Dist...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Registrant Name : Korea United Pharmaceutical Co., Ltd.
Registration Date : 2017-06-28
Registration Number : Su207-29-ND(1)
Manufacturer Name : Teva API India Pvt. LTD.
Manufacturer Address : Plot no. Q1 to Q4, Industrial Area, Ghirongi, Malanpur, Distt. Bhind M.P., India
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Registrant Name : Sam-O Pharmaceutical Co., Ltd.
Registration Date : 2016-11-24
Registration Number : Su207-29-ND
Manufacturer Name : Teva API India Pvt. Ltd.
Manufacturer Address : Plot no. Q1 to Q4, Industrial Area, Ghirongi, Malanpur, Distt. Bhind M.P., India
Qingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.
Registrant Name : Otran Korea Co., Ltd.
Registration Date : 2022-12-20
Registration Number : Su695-14-ND
Manufacturer Name : Sichuan Qingmu Pharmaceutica...
Manufacturer Address : No. 55, South Shunjiang Avenue, East Economic Development Zone, Dongpo District, Meis...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Coating Systems & Additives
Controlled & Modified Release
Film Formers & Plasticizers
Empty Capsules
Solubilizers
Fillers, Diluents & Binders
Vegetarian Capsules
API Stability Enhancers
Emulsifying Agents
Thickeners and Stabilizers
Parenteral
Topical
Lubricants & Glidants
Taste Masking
Granulation
Coloring Agents
Direct Compression
Chewable & Orodispersible Aids
Soft Gelatin
Disintegrants & Superdisintegrants
Rheology Modifiers
Digital Content
DATA COMPILATION #PharmaFlow
WEEKLY NEWS RECAP #Phispers
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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, 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.
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, and COA 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, and COA 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, 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).
