01 1Apitoria Pharma Private Limited
02 1Aurobindo Pharma Limited
03 1Cheer Fine Pharmaceutical Co. , Ltd.
04 1Glenmark Life Sciences Limited
05 1Guilin Hwasun Pharmaceutical Co. , Ltd.
06 1HETERO DRUGS LIMITED.
07 1SHOUGUANG FUKANG PHARMACEUTICAL CO. , LTD.
01 1Esomeprazole Magnesium Hydrate "D"
02 4Esomeprazole magnesium hydrate
03 1esomeprazole magnesium hydrate
04 1Blank
01 3China
02 4India
Esomeprazole magnesium hydrate
Registration Number : 303MF10137
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Telangana, India
Initial Date of Registration : 2021-08-20
Latest Date of Registration : 2021-08-20
Esomeprazole magnesium hydrate "Apitoria"
Registration Number : 306MF10086
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, INDIA.
Initial Date of Registration : 2024-07-03
Latest Date of Registration : 2024-07-03
Esomeprazole magnesium hydrate
Registration Number : 303MF10107
Registrant's Address : No. 2066 Tangkou Road, Economy and Technology Development Zone, Hefei, Anhui Province...
Initial Date of Registration : 2021-07-09
Latest Date of Registration : 2021-07-09
Esomeprazole magnesium hydrate
Registration Number : 303MF10113
Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Mahara...
Initial Date of Registration : 2021-07-16
Latest Date of Registration : 2021-07-16
Esomeprazole magnesium hydrate
Registration Number : 303MF10115
Registrant's Address : No. 89 1st street, Lingbei Road, Lingchuan, Guilin Guangxi, PR China
Initial Date of Registration : 2021-07-20
Latest Date of Registration : 2021-07-20
Esomeprazole magnesium hydrate "D"
Registration Number : 301MF10050
Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telang...
Initial Date of Registration : 2019-08-20
Latest Date of Registration : 2019-08-20
Esomeprazole magnesium hydrate
Registration Number : 303MF10042
Registrant's Address : NORTH-EAST OF DONGWAIHUAN ROAD, DONGCHENG INDUSTRIAL AREA, SHOUGUANG CITY, SHANDONG, ...
Initial Date of Registration : 2021-03-15
Latest Date of Registration : 2021-03-15
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, COA and API Price 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, COA and API Price related information 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.
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