Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
API SUPPLIERS
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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 : Complete
Rev. Date : 2019-11-25
Pay. Date : 2019-10-16
DMF Number : 34026
Submission : 2019-10-04
Status :
Type : II
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
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
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
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 : 2014-07-07
Pay. Date : 2014-04-21
DMF Number : 28127
Submission : 2014-03-31
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
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Alemtuzumab, Cetirizine, Ranitidine, Methylprednisolone, Acyclovir
Therapeutic Area : Neurology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA
Details : Alemtuzumab is a Antibody drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Multiple Sclerosis, Relapsing-Remitting.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
July 31, 2014
Lead Product(s) : Esomeprazole Magnesium,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Acino Pharma
Deal Size : $119.4 million
Deal Type : Acquisition
Acino Acquires Selected Aspen Brands in South Africa
Details : The transaction includes Trustan, Altosec, Zuvamor, Ciavor, Grantryl and Aspen Granisetron brands. To secure uninterrupted patient access to these medicines, the parties have also signed a manufacturing and supply agreement.
Product Name : Trustan
Product Type : Miscellaneous
Upfront Cash : Undisclosed
October 22, 2021
Lead Product(s) : Esomeprazole Magnesium,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Notice of Approval for Esomeprazole Capsules with New Manufacturing Plant Addition
Details : Esomeprazole magnesium hydrate capsules is a proton pump inhibitor indicated for the treatment of gastroesophageal reflux disease and NSAID-associated gastric ulcer.
Product Name : Esomeprazole-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 14, 2024
Lead Product(s) : Esomeprazole Magnesium,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Granules India Gets USFDA Nod for Generic Drug Used for Short-term Treatment of Heartburn
Details : Esomeprazole magnesium delayed-release capsules is a proton pump inhibitor indicated for the treatment of gastroesophageal reflux disease and NSAID-associated gastric ulcer.
Product Name : Nexium-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 19, 2023
Lead Product(s) : Sevabertinib,Esomeprazole Magnesium
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : BAY2927088 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 22, 2024
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
2-Hydroxymethyl-3,5-dimethyl,4-methoxy pyridine (O...
CAS Number : 86604-78-6
End Use API : Esomeprazole Magnesium
About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
2-Chloromethyl-3,5-dimethyl-4-methoxypyridine HCl ...
CAS Number : 86604-75-3
End Use API : Esomeprazole Magnesium
About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
5-Methoxy-2[[(4-methoxy-3,5-dimethyl-2-methylpyrid...
CAS Number : 73590-85-9
End Use API : Esomeprazole Magnesium
About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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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REF. STANDARDS & IMPURITIES
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ANALYTICAL
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 Esomeprazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Esomeprazole, including repackagers and relabelers. The FDA regulates Esomeprazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Esomeprazole 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Esomeprazole supplier is an individual or a company that provides Esomeprazole active pharmaceutical ingredient (API) or Esomeprazole finished formulations upon request. The Esomeprazole suppliers may include Esomeprazole API manufacturers, exporters, distributors and traders.
click here to find a list of Esomeprazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Esomeprazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Esomeprazole active pharmaceutical ingredient (API) in detail. Different forms of Esomeprazole DMFs exist exist since differing nations have different regulations, such as Esomeprazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Esomeprazole DMF submitted to regulatory agencies in the US is known as a USDMF. Esomeprazole USDMF includes data on Esomeprazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Esomeprazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Esomeprazole 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 Esomeprazole Drug Master File in Japan (Esomeprazole JDMF) empowers Esomeprazole 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 Esomeprazole JDMF during the approval evaluation for pharmaceutical products. At the time of Esomeprazole 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 Esomeprazole 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 Esomeprazole Drug Master File in Korea (Esomeprazole KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Esomeprazole. The MFDS reviews the Esomeprazole KDMF as part of the drug registration process and uses the information provided in the Esomeprazole KDMF to evaluate the safety and efficacy of the drug.
After submitting a Esomeprazole 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Esomeprazole suppliers with KDMF on PharmaCompass.
A Esomeprazole CEP of the European Pharmacopoeia monograph is often referred to as a Esomeprazole Certificate of Suitability (COS). The purpose of a Esomeprazole CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Esomeprazole EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Esomeprazole to their clients by showing that a Esomeprazole CEP has been issued for it. The manufacturer submits a Esomeprazole CEP (COS) as part of the market authorization procedure, and it takes on the role of a Esomeprazole CEP holder for the record. Additionally, the data presented in the Esomeprazole CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Esomeprazole DMF.
A Esomeprazole CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Esomeprazole 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 suppliers with CEP (COS) on PharmaCompass.
A Esomeprazole written confirmation (Esomeprazole WC) is an official document issued by a regulatory agency to a Esomeprazole manufacturer, verifying that the manufacturing facility of a Esomeprazole active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Esomeprazole APIs or Esomeprazole finished pharmaceutical products to another nation, regulatory agencies frequently require a Esomeprazole WC (written confirmation) as part of the regulatory process.
click here to find a list of Esomeprazole 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Esomeprazole 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Esomeprazole NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Esomeprazole suppliers with NDC on PharmaCompass.
Esomeprazole 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 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Esomeprazole GMP manufacturer or Esomeprazole GMP API supplier for your needs.
A Esomeprazole CoA (Certificate of Analysis) is a formal document that attests to Esomeprazole's compliance with Esomeprazole specifications and serves as a tool for batch-level quality control.
Esomeprazole CoA mostly includes findings from lab analyses of a specific batch. For each Esomeprazole 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Esomeprazole EP), Esomeprazole JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Esomeprazole USP).
