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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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Data Compilation #PharmaFlow
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API SUPPLIERS
With Virupaksha, you get a quality product with on-time delivery.
Axplora is your partner of choice for complex APIs.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Jai Radhe Sales is your partner for all your sourcing needs.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
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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]KDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
With Virupaksha, you get a quality product with on-time delivery.
About the Company : Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylaram produce high-qual...
Axplora is your partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
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...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Nuray Chemicals Pvt Ltd, established in 2012 near Chennai, is an API manufacturer for highly regulated markets. Its state-of-the-art R&D facility specializes in synthesizing NCEs, ...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology p...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of experience in formulation development, manufacturing, and commercialization. Its portfoli...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
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), phytochemicals, herba...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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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 Etoricoxib [USAN:INN:BAN] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Etoricoxib [USAN:INN:BAN], including repackagers and relabelers. The FDA regulates Etoricoxib [USAN:INN:BAN] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Etoricoxib [USAN:INN:BAN] API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Etoricoxib [USAN:INN:BAN] supplier is an individual or a company that provides Etoricoxib [USAN:INN:BAN] active pharmaceutical ingredient (API) or Etoricoxib [USAN:INN:BAN] finished formulations upon request. The Etoricoxib [USAN:INN:BAN] suppliers may include Etoricoxib [USAN:INN:BAN] API manufacturers, exporters, distributors and traders.
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A Etoricoxib [USAN:INN:BAN] DMF (Drug Master File) is a document detailing the whole manufacturing process of Etoricoxib [USAN:INN:BAN] active pharmaceutical ingredient (API) in detail. Different forms of Etoricoxib [USAN:INN:BAN] DMFs exist exist since differing nations have different regulations, such as Etoricoxib [USAN:INN:BAN] USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Etoricoxib [USAN:INN:BAN] DMF submitted to regulatory agencies in the US is known as a USDMF. Etoricoxib [USAN:INN:BAN] USDMF includes data on Etoricoxib [USAN:INN:BAN]'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Etoricoxib [USAN:INN:BAN] USDMF is kept confidential to protect the manufacturer’s intellectual property.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Etoricoxib [USAN:INN:BAN] Drug Master File in Korea (Etoricoxib [USAN:INN:BAN] KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Etoricoxib [USAN:INN:BAN]. The MFDS reviews the Etoricoxib [USAN:INN:BAN] KDMF as part of the drug registration process and uses the information provided in the Etoricoxib [USAN:INN:BAN] KDMF to evaluate the safety and efficacy of the drug.
After submitting a Etoricoxib [USAN:INN:BAN] 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 Etoricoxib [USAN:INN:BAN] API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Etoricoxib [USAN:INN:BAN] suppliers with KDMF on PharmaCompass.
A Etoricoxib [USAN:INN:BAN] written confirmation (Etoricoxib [USAN:INN:BAN] WC) is an official document issued by a regulatory agency to a Etoricoxib [USAN:INN:BAN] manufacturer, verifying that the manufacturing facility of a Etoricoxib [USAN:INN:BAN] active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Etoricoxib [USAN:INN:BAN] APIs or Etoricoxib [USAN:INN:BAN] finished pharmaceutical products to another nation, regulatory agencies frequently require a Etoricoxib [USAN:INN:BAN] WC (written confirmation) as part of the regulatory process.
click here to find a list of Etoricoxib [USAN:INN:BAN] 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 Etoricoxib [USAN:INN:BAN] as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Etoricoxib [USAN:INN:BAN] 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 Etoricoxib [USAN:INN:BAN] 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 Etoricoxib [USAN:INN:BAN] and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Etoricoxib [USAN:INN:BAN] NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Etoricoxib [USAN:INN:BAN] suppliers with NDC on PharmaCompass.
Etoricoxib [USAN:INN:BAN] 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 Etoricoxib [USAN:INN:BAN] GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Etoricoxib [USAN:INN:BAN] GMP manufacturer or Etoricoxib [USAN:INN:BAN] GMP API supplier for your needs.
A Etoricoxib [USAN:INN:BAN] CoA (Certificate of Analysis) is a formal document that attests to Etoricoxib [USAN:INN:BAN]'s compliance with Etoricoxib [USAN:INN:BAN] specifications and serves as a tool for batch-level quality control.
Etoricoxib [USAN:INN:BAN] CoA mostly includes findings from lab analyses of a specific batch. For each Etoricoxib [USAN:INN:BAN] 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.
Etoricoxib [USAN:INN:BAN] may be tested according to a variety of international standards, such as European Pharmacopoeia (Etoricoxib [USAN:INN:BAN] EP), Etoricoxib [USAN:INN:BAN] JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Etoricoxib [USAN:INN:BAN] USP).
