Synopsis
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CEP/COS
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JDMF
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VMF
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FDA Orange Book
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Canada
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Australia
DRUG PRODUCT COMPOSITIONS
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US Patents
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US Exclusivities
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Health Canada Patents
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
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 : 34537
Submission : 2020-02-22
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 : 41843
Submission : 2025-06-24
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
2-Chloro-1,3-bis(dimethylamino)trimethinium hexafl...
CAS Number : 249561-98-6
End Use API : Etoricoxib
About The Company : Zeon Pharma Industries India Pvt. Ltd. is an ISO 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), p...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
4-(methyl sulfonyl)-phenyl acetic acid
CAS Number : 90536-66-6
End Use API : Etoricoxib
About The Company : Zeon Pharma Industries India Pvt. Ltd. is an ISO 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), p...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
CAS Number : 10297-73-1
End Use API : Etoricoxib
About The Company : Zeon Pharma Industries India Pvt. Ltd. is an ISO 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), p...
Oxygenta Pharmaceutical Limited — Powering healthcare through reliable pharmaceuticals and organic fine chemicals
CAS Number : 291756-76-8
End Use API : Etoricoxib
About The Company : Oxygenta Pharmaceutical Limited was incorporated as a private limited company in 1990 and later converted into a limited company in 1993. The company was establ...
Oxygenta Pharmaceutical Limited — Powering healthcare through reliable pharmaceuticals and organic fine chemicals
2-Butyl-4-chloro-5-Formyl-1H-Imidazole(BCFI)
CAS Number : 221615-75-4
End Use API : Etoricoxib
About The Company : Oxygenta Pharmaceutical Limited was incorporated as a private limited company in 1990 and later converted into a limited company in 1993. The company was establ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
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 : Etoricoxib Zentiva
Dosage Form : Film Coated Tablet
Dosage Strength : 30mg
Packaging :
Approval Date : 24/02/2022
Application Number : 68245
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 : Etoricoxib Zentiva
Dosage Form : Film Coated Tablet
Dosage Strength : 60mg
Packaging :
Approval Date : 24/02/2022
Application Number : 68245
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Etoricoxib Orion
Dosage Form : Film Coated Tablet
Dosage Strength : 30mg
Packaging :
Approval Date : 02-12-2016
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Etoricoxib Orion
Dosage Form : Film Coated Tablet
Dosage Strength : 60mg
Packaging :
Approval Date : 02-12-2016
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Etoricoxib Orion
Dosage Form : Film Coated Tablet
Dosage Strength : 90mg
Packaging :
Approval Date : 02-12-2016
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Etoricoxib Orion
Dosage Form : Film Coated Tablet
Dosage Strength : 120mg
Packaging :
Approval Date : 02-12-2016
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Etoricoxib \"Strides\"
Dosage Form : Film Coated Tablet
Dosage Strength : 120mg
Packaging :
Approval Date : 18-03-2024
Application Number : 28107075623
Regulatory Info : Prescription
Registration Country : Denmark
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Etoricoxib \"Strides\"
Dosage Form : Film Coated Tablet
Dosage Strength : 30mg
Packaging :
Approval Date : 18-03-2024
Application Number : 28107074823
Regulatory Info : Prescription
Registration Country : Denmark
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Etoricoxib \"Strides\"
Dosage Form : Film Coated Tablet
Dosage Strength : 60mg
Packaging :
Approval Date : 18-03-2024
Application Number : 28107075423
Regulatory Info : Prescription
Registration Country : Denmark
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Etoricoxib \"Strides\"
Dosage Form : Film Coated Tablet
Dosage Strength : 90mg
Packaging :
Approval Date : 18-03-2024
Application Number : 28107075523
Regulatory Info : Prescription
Registration Country : Denmark
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Etoricoxib 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 Etoricoxib manufacturer or Etoricoxib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Etoricoxib manufacturer or Etoricoxib supplier.
A Tauxib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tauxib, including repackagers and relabelers. The FDA regulates Tauxib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tauxib 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 Tauxib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Tauxib supplier is an individual or a company that provides Tauxib active pharmaceutical ingredient (API) or Tauxib finished formulations upon request. The Tauxib suppliers may include Tauxib API manufacturers, exporters, distributors and traders.
click here to find a list of Tauxib suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Tauxib DMF (Drug Master File) is a document detailing the whole manufacturing process of Tauxib active pharmaceutical ingredient (API) in detail. Different forms of Tauxib DMFs exist exist since differing nations have different regulations, such as Tauxib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tauxib DMF submitted to regulatory agencies in the US is known as a USDMF. Tauxib USDMF includes data on Tauxib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tauxib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tauxib 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 Tauxib Drug Master File in Korea (Tauxib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tauxib. The MFDS reviews the Tauxib KDMF as part of the drug registration process and uses the information provided in the Tauxib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tauxib 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 Tauxib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tauxib suppliers with KDMF on PharmaCompass.
A Tauxib written confirmation (Tauxib WC) is an official document issued by a regulatory agency to a Tauxib manufacturer, verifying that the manufacturing facility of a Tauxib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tauxib APIs or Tauxib finished pharmaceutical products to another nation, regulatory agencies frequently require a Tauxib WC (written confirmation) as part of the regulatory process.
click here to find a list of Tauxib 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 Tauxib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tauxib 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 Tauxib 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 Tauxib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tauxib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tauxib suppliers with NDC on PharmaCompass.
Tauxib 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 Tauxib GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Tauxib GMP manufacturer or Tauxib GMP API supplier for your needs.
A Tauxib CoA (Certificate of Analysis) is a formal document that attests to Tauxib's compliance with Tauxib specifications and serves as a tool for batch-level quality control.
Tauxib CoA mostly includes findings from lab analyses of a specific batch. For each Tauxib 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.
Tauxib may be tested according to a variety of international standards, such as European Pharmacopoeia (Tauxib EP), Tauxib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tauxib USP).
