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JDMF
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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
EU-WC
NDC
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
Neuland Laboratories- A dedicated 100% API provider.
EU-WC
NDC
ASMF
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
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USDMF
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Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
About the Company : Bal Pharma is a leading Indian pharmaceutical company with 30+ years of experience, specializing in prescription drugs, generic and OTC products, intravenous infusions, and bulk ac...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
About the Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include c...
Neuland Laboratories- A dedicated 100% API provider.
About the Company : Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the p...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
Lead Product(s) : Dabigatran Etexilate Mesylate
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
April 22, 2022
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Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
CAS Number : 42288-26-6
End Use API : Dabigatran Etexilate Mesylate
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
4-Methylamino-3-nitro benzoic acid
CAS Number : 41263-74-5
End Use API : Dabigatran Etexilate Mesylate
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
N-Ethyl 3-(pyridin-2-ylamino)propanoate
CAS Number : 103041-38-9
End Use API : Dabigatran Etexilate Mesylate
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
ethyl N-[3-amino-4- (methylamino)benzoyl]-N- pyrid...
CAS Number : 212322-56-0
End Use API : Dabigatran Etexilate Mesylate
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
CAS Number : 42288-26-6
End Use API : Dabigatran Etexilate Mesylate
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
Sichuan Qingmu Pharmaceutical offers reliable CDMO support and high-quality APIs for regulated markets.
4-Aminobenzamidine dihydrochloride
CAS Number : 2498-50-2
End Use API : Dabigatran Etexilate Mesylate
About The Company : Sichuan Qingmu Pharmaceutical Co., Ltd. is an innovation-driven pharmaceutical company focused on regulated markets. We specialize in the R&D and manufacturing ...
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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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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
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Controlled & Modified Release
Thickeners and Stabilizers
Film Formers & Plasticizers
Rheology Modifiers
Empty Capsules
Coloring Agents
Solubilizers
Fillers, Diluents & Binders
Vegetarian Capsules
API Stability Enhancers
Emulsifying Agents
Parenteral
Topical
Lubricants & Glidants
Taste Masking
Granulation
Direct Compression
Soft Gelatin
Disintegrants & Superdisintegrants
Chewable & Orodispersible Aids
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
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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 Pradaxa manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pradaxa, including repackagers and relabelers. The FDA regulates Pradaxa manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pradaxa 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 Pradaxa manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pradaxa supplier is an individual or a company that provides Pradaxa active pharmaceutical ingredient (API) or Pradaxa finished formulations upon request. The Pradaxa suppliers may include Pradaxa API manufacturers, exporters, distributors and traders.
click here to find a list of Pradaxa suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pradaxa DMF (Drug Master File) is a document detailing the whole manufacturing process of Pradaxa active pharmaceutical ingredient (API) in detail. Different forms of Pradaxa DMFs exist exist since differing nations have different regulations, such as Pradaxa USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pradaxa DMF submitted to regulatory agencies in the US is known as a USDMF. Pradaxa USDMF includes data on Pradaxa's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pradaxa USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pradaxa 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 Pradaxa Drug Master File in Korea (Pradaxa KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pradaxa. The MFDS reviews the Pradaxa KDMF as part of the drug registration process and uses the information provided in the Pradaxa KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pradaxa 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 Pradaxa API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pradaxa suppliers with KDMF on PharmaCompass.
A Pradaxa CEP of the European Pharmacopoeia monograph is often referred to as a Pradaxa Certificate of Suitability (COS). The purpose of a Pradaxa CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pradaxa EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pradaxa to their clients by showing that a Pradaxa CEP has been issued for it. The manufacturer submits a Pradaxa CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pradaxa CEP holder for the record. Additionally, the data presented in the Pradaxa CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pradaxa DMF.
A Pradaxa CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pradaxa 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 Pradaxa suppliers with CEP (COS) on PharmaCompass.
A Pradaxa written confirmation (Pradaxa WC) is an official document issued by a regulatory agency to a Pradaxa manufacturer, verifying that the manufacturing facility of a Pradaxa active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pradaxa APIs or Pradaxa finished pharmaceutical products to another nation, regulatory agencies frequently require a Pradaxa WC (written confirmation) as part of the regulatory process.
click here to find a list of Pradaxa 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 Pradaxa as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pradaxa 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 Pradaxa 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 Pradaxa and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pradaxa NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pradaxa suppliers with NDC on PharmaCompass.
Pradaxa 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 Pradaxa 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 Pradaxa GMP manufacturer or Pradaxa GMP API supplier for your needs.
A Pradaxa CoA (Certificate of Analysis) is a formal document that attests to Pradaxa's compliance with Pradaxa specifications and serves as a tool for batch-level quality control.
Pradaxa CoA mostly includes findings from lab analyses of a specific batch. For each Pradaxa 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.
Pradaxa may be tested according to a variety of international standards, such as European Pharmacopoeia (Pradaxa EP), Pradaxa JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pradaxa USP).
