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API SUPPLIERS
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
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NDC
KDMF
CN
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
NDC
ASMF
Minakem is manufacturing small molecules APIs including corticosteroids
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
CEP/COS
EU-WC
NDC
KDMF
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Jai Radhe Sales is your partner for all your sourcing needs.
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USDMF
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28462
Submission : 2014-07-08
Status :
Type : II
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-25
Pay. Date : 2019-10-16
DMF Number : 34026
Submission : 2019-10-04
Status :
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37233
Submission : 2022-07-01
Status :
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-26
Pay. Date : 2023-04-18
DMF Number : 36556
Submission : 2021-12-24
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 : 35519
Submission : 2020-12-29
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 : Complete
Rev. Date : 2026-03-04
Pay. Date : 2026-02-06
DMF Number : 35400
Submission : 2020-11-28
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-18
Pay. Date : 2013-01-16
DMF Number : 25858
Submission : 2012-03-30
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-07
Pay. Date : 2013-01-16
DMF Number : 23994
Submission : 2010-07-26
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 : 28127
Submission : 2014-03-31
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Esomeprazole Magnesium Trihydrate, Micronised, N...
Certificate Number : R1-CEP 2012-256 - Rev 02
Status : Valid
Issue Date : 2021-06-03
Type : Chemical
Substance Number : 2372
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Esomeprazole Magnesium Trihydrate
Certificate Number : CEP 2020-386 - Rev 03
Status : Valid
Issue Date : 2026-01-26
Type : Chemical
Substance Number : 2372
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Esomeprazole Magnesium Dihydrate
Certificate Number : CEP 2021-022 - Rev 01
Status : Valid
Issue Date : 2024-06-20
Type : Chemical
Substance Number : 2787
Esomeprazole Magnesium Dihydrate, Form A - Micro...
Certificate Number : R1-CEP 2015-043 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2020-12-02
Type : Chemical
Substance Number : 2787
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Esomeprazole Magnesium Trihydrate, EMT-2 Process
Certificate Number : R0-CEP 2023-070 - Rev 00
Status : Valid
Issue Date : 2023-06-15
Type : Chemical
Substance Number : 2372
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Esomeprazole Magnesium Trihydrate
Certificate Number : R1-CEP 2012-395 - Rev 01
Status : Valid
Issue Date : 2023-06-05
Type : Chemical
Substance Number : 2372
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Esomeprazole Magnesium Trihydrate, Process II
Certificate Number : R0-CEP 2021-243 - Rev 00
Status : Valid
Issue Date : 2022-01-03
Type : Chemical
Substance Number : 2372
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
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Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
esomeprazole magnesium trihydrate
Registrant Name : AstraZeneca Korea
Registration Date : 2010-10-29
Registration Number : 20101029-127-H-21-05
Manufacturer Name : Minakem Dunkerque Production
Manufacturer Address : 224 avenue de la Dordogne Zone d'Entreprises du Nord Gracht 59640 Dunkerque, France
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
esomeprazole magnesium trihydrate
Registrant Name : Daehan Newpharm Co., Ltd.
Registration Date : 2020-03-11
Registration Number : 20180627-127-H-339-30(4)
Manufacturer Name : Minakem Dunkerque production
Manufacturer Address : 224 avenue de la Dordogne Zone d'entreprises du Nord Gracht Dunkerque, 59640 France
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
esomeprazole magnesium trihydrate
Registrant Name : Pharma Solution Co., Ltd.
Registration Date : 2019-04-04
Registration Number : 20180627-127-H-339-30(1)
Manufacturer Name : Minakem Dunkerque production
Manufacturer Address : 224 avenue de la Dordogne Zone d'entreprises du Nord Gracht Dunkerque, 59640 France
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
esomeprazole magnesium trihydrate
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2020-02-06
Registration Number : 20180627-127-H-339-30(3)
Manufacturer Name : Minakem Dunkerque production
Manufacturer Address : 224 avenue de la Dordogne Zone d'entreprises du Nord Gracht Dunkerque, 59640 France
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
esomeprazole magnesium trihydrate
Registrant Name : MPK Korea Co., Ltd.
Registration Date : 2019-12-24
Registration Number : 20180627-127-H-339-30(2)
Manufacturer Name : Minakem Dunkerque production
Manufacturer Address : 224 avenue de la Dordogne Zone d'entreprises du Nord Gracht Dunkerque, 59640 France
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
esomeprazole magnesium trihydrate
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2018-06-27
Registration Number : 20180627-127-H-339-30
Manufacturer Name : Minakem Dunkerque production
Manufacturer Address : 224 avenue de la Dordogne Zone d'entreprises du Nord Gracht Dunkerque, 59640 France
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
esomeprazole magnesium dihydrate
Registrant Name : Korea United Pharmaceutical Co., Ltd.
Registration Date : 2021-08-10
Registration Number : 20200904-127-H-381-38(1)
Manufacturer Name : Athena Drug Delivery Solutio...
Manufacturer Address : Plot No. A-1 to A-5, MIDC, Chemical zone, Ambernath(W), Thane 421 501 Maharashtra Sta...
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
esomeprazole magnesium dihydrate
Registrant Name : Wooshin Labotach Co., Ltd.
Registration Date : 2020-09-04
Registration Number : 20200904-127-H-381-38
Manufacturer Name : Athena Drug Delivery Solutio...
Manufacturer Address : Plot No. A-1 to A-5, MIDC, Chemical zone, Ambernath(W), Thane 421 501 Maharashtra Sta...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
esomeprazole magnesium trihydrate
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2025-12-11
Registration Number : 20151230-127-H-290-20(6)
Manufacturer Name : Metrochem API PVT LTD
Manufacturer Address : Unit-I, Plot No. 62/C/6, Pipeline Road, Phase-I, IDA., Jeedimetla, Quthbullapur (M), ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Esomeprazole magnesium hydrate
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2025-08-05
Registration Number : 20151230-127-H-290-20(5)
Manufacturer Name : Metrochem API PVT LTD
Manufacturer Address : Unit-I, Plot No. 62/C/6, Pipeline Road, Phase-I, IDA., Jeedimetla, Quthbullapur (M), ...
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DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 2...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 20MG BASE
USFDA APPLICATION NUMBER - 204655
DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE
USFDA APPLICATION NUMBER - 21153
DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 40MG BASE
USFDA APPLICATION NUMBER - 21153
DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 2.5MG BASE/PACKET
USFDA APPLICATION NUMBER - 21957
DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 20MG BASE/PACKET
USFDA APPLICATION NUMBER - 21957
DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 40MG BASE/PACKET
USFDA APPLICATION NUMBER - 21957
DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 5MG BASE/PACKET
USFDA APPLICATION NUMBER - 21957
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22511
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22511
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ABOUT THIS PAGE
36
PharmaCompass offers a list of Esomeprazole Magnesium 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 Esomeprazole Magnesium manufacturer or Esomeprazole Magnesium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Esomeprazole Magnesium manufacturer or Esomeprazole Magnesium supplier.
A Nexium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nexium, including repackagers and relabelers. The FDA regulates Nexium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nexium 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 Nexium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Nexium supplier is an individual or a company that provides Nexium active pharmaceutical ingredient (API) or Nexium finished formulations upon request. The Nexium suppliers may include Nexium API manufacturers, exporters, distributors and traders.
click here to find a list of Nexium suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Nexium DMF (Drug Master File) is a document detailing the whole manufacturing process of Nexium active pharmaceutical ingredient (API) in detail. Different forms of Nexium DMFs exist exist since differing nations have different regulations, such as Nexium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nexium DMF submitted to regulatory agencies in the US is known as a USDMF. Nexium USDMF includes data on Nexium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nexium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nexium suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Nexium Drug Master File in Japan (Nexium JDMF) empowers Nexium API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Nexium JDMF during the approval evaluation for pharmaceutical products. At the time of Nexium JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Nexium suppliers with JDMF 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 Nexium Drug Master File in Korea (Nexium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nexium. The MFDS reviews the Nexium KDMF as part of the drug registration process and uses the information provided in the Nexium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nexium 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 Nexium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nexium suppliers with KDMF on PharmaCompass.
A Nexium CEP of the European Pharmacopoeia monograph is often referred to as a Nexium Certificate of Suitability (COS). The purpose of a Nexium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nexium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nexium to their clients by showing that a Nexium CEP has been issued for it. The manufacturer submits a Nexium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nexium CEP holder for the record. Additionally, the data presented in the Nexium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nexium DMF.
A Nexium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nexium 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 Nexium suppliers with CEP (COS) on PharmaCompass.
A Nexium written confirmation (Nexium WC) is an official document issued by a regulatory agency to a Nexium manufacturer, verifying that the manufacturing facility of a Nexium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nexium APIs or Nexium finished pharmaceutical products to another nation, regulatory agencies frequently require a Nexium WC (written confirmation) as part of the regulatory process.
click here to find a list of Nexium 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 Nexium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nexium 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 Nexium 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 Nexium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nexium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nexium suppliers with NDC on PharmaCompass.
Nexium 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 Nexium GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Nexium GMP manufacturer or Nexium GMP API supplier for your needs.
A Nexium CoA (Certificate of Analysis) is a formal document that attests to Nexium's compliance with Nexium specifications and serves as a tool for batch-level quality control.
Nexium CoA mostly includes findings from lab analyses of a specific batch. For each Nexium 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.
Nexium may be tested according to a variety of international standards, such as European Pharmacopoeia (Nexium EP), Nexium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nexium USP).
