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JDMF
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API SUPPLIERS
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
CEP/COS
EU-WC
KDMF
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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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 : 28026
Submission : 2014-02-19
Status :
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28375
Submission : 2014-06-09
Status :
Type : II
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Certificate Number : CEP 2020-214 - Rev 02
Status : Valid
Issue Date : 2025-02-07
Type : Chemical
Substance Number : 2923
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Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2011-11-04
Registration Number : 20111104-127-H-192-07
Manufacturer Name : Minakem Dunkerque Production
Manufacturer Address : 224 avenue de la Dordogne Zone d'Entreprises du Nord Gracht 59640 Dunkerque, France
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Registrant Name : Hiple Co., Ltd.
Registration Date : 2017-10-31
Registration Number : 20171031-127-H-320-29
Manufacturer Name : Metrochem API Private Limite...
Manufacturer Address : Unit-Ⅰ, Plot. No. 62/C/6, Pipeline Road Phase-I, IDA, Jeedimetla, Quthbullapur Mand...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2019-11-05
Registration Number : 20171031-127-H-320-29(2)
Manufacturer Name : Metrochem API Private Limite...
Manufacturer Address : Unit-Ⅰ, Plot. No. 62/C/6, Pipeline Road Phase-I, IDA, Jeedimetla, Quthbullapur Mand...
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DOSAGE - INJECTABLE;INTRAVENOUS - EQ 20MG BAS...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21689
DOSAGE - INJECTABLE;INTRAVENOUS - EQ 40MG BAS...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 40MG BASE/VIAL
USFDA APPLICATION NUMBER - 21689
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ABOUT THIS PAGE
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PharmaCompass offers a list of Esomeprazole Sodium 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 Esomeprazole Sodium manufacturer or Esomeprazole Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Esomeprazole Sodium manufacturer or Esomeprazole Sodium supplier.
PharmaCompass also assists you with knowing the Esomeprazole Sodium API Price utilized in the formulation of products. Esomeprazole Sodium API Price is not always fixed or binding as the Esomeprazole Sodium Price is obtained through a variety of data sources. The Esomeprazole Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Esomeprazole Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Esomeprazole Sodium, including repackagers and relabelers. The FDA regulates Esomeprazole Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Esomeprazole Sodium 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 Esomeprazole Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Esomeprazole Sodium supplier is an individual or a company that provides Esomeprazole Sodium active pharmaceutical ingredient (API) or Esomeprazole Sodium finished formulations upon request. The Esomeprazole Sodium suppliers may include Esomeprazole Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Esomeprazole Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Esomeprazole Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Esomeprazole Sodium active pharmaceutical ingredient (API) in detail. Different forms of Esomeprazole Sodium DMFs exist exist since differing nations have different regulations, such as Esomeprazole Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Esomeprazole Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Esomeprazole Sodium USDMF includes data on Esomeprazole Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Esomeprazole Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Esomeprazole Sodium 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 Esomeprazole Sodium Drug Master File in Korea (Esomeprazole Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Esomeprazole Sodium. The MFDS reviews the Esomeprazole Sodium KDMF as part of the drug registration process and uses the information provided in the Esomeprazole Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Esomeprazole Sodium 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 Esomeprazole Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Esomeprazole Sodium suppliers with KDMF on PharmaCompass.
A Esomeprazole Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Esomeprazole Sodium Certificate of Suitability (COS). The purpose of a Esomeprazole Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Esomeprazole Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Esomeprazole Sodium to their clients by showing that a Esomeprazole Sodium CEP has been issued for it. The manufacturer submits a Esomeprazole Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Esomeprazole Sodium CEP holder for the record. Additionally, the data presented in the Esomeprazole Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Esomeprazole Sodium DMF.
A Esomeprazole Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Esomeprazole Sodium 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 Esomeprazole Sodium suppliers with CEP (COS) on PharmaCompass.
A Esomeprazole Sodium written confirmation (Esomeprazole Sodium WC) is an official document issued by a regulatory agency to a Esomeprazole Sodium manufacturer, verifying that the manufacturing facility of a Esomeprazole Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Esomeprazole Sodium APIs or Esomeprazole Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Esomeprazole Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Esomeprazole Sodium 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 Esomeprazole Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Esomeprazole Sodium 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 Esomeprazole Sodium 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 Esomeprazole Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Esomeprazole Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Esomeprazole Sodium suppliers with NDC on PharmaCompass.
Esomeprazole Sodium 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 Esomeprazole Sodium 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 Esomeprazole Sodium GMP manufacturer or Esomeprazole Sodium GMP API supplier for your needs.
A Esomeprazole Sodium CoA (Certificate of Analysis) is a formal document that attests to Esomeprazole Sodium's compliance with Esomeprazole Sodium specifications and serves as a tool for batch-level quality control.
Esomeprazole Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Esomeprazole Sodium 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.
Esomeprazole Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Esomeprazole Sodium EP), Esomeprazole Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Esomeprazole Sodium USP).
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