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List of Drug Master Files (JDMF) for Esomeprazole Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 Aurobindo Pharma Limited (1)

02 Cheer Fine Pharmaceutical Co. , Ltd. (1)

03 Glenmark Life Sciences Limited (1)

04 Guilin Hwasun Pharmaceutical Co. , Ltd. (1)

05 HETERO DRUGS LIMITED. (1)

06 SHOUGUANG FUKANG PHARMACEUTICAL CO. , LTD. (1)

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01 Esomeprazole Magnesium Hydrate "D" (1)

02 Esomeprazole magnesium hydrate (4)

03 esomeprazole magnesium hydrate (1)

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01 China (3)

02 India (3)

URL Supplier Web Content
303MF10137
Plot No. 2, Maitrivihar, Ameerpet, ...
2021-08-20
2021-08-20
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303MF10107
No. 2066 Tangkou Road, Economy and ...
2021-07-09
2021-07-09
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303MF10113
4th Floor, OIA House, 470, Cardinal...
2021-07-16
2021-07-16
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303MF10115
No. 89 1st street, Lingbei Road, Li...
2021-07-20
2021-07-20
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301MF10050
7-2-A2, Hetero Corporate, Industria...
2019-08-20
2019-08-20
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303MF10042
NORTH-EAST OF DONGWAIHUAN ROAD, DON...
2021-03-15
2021-03-15
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Looking for 95382-33-5 / Esomeprazole Magnesium API manufacturers, exporters & distributors?

Esomeprazole Magnesium manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Esomeprazole Magnesium 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 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.

PharmaCompass also assists you with knowing the Esomeprazole Magnesium API Price utilized in the formulation of products. Esomeprazole Magnesium API Price is not always fixed or binding as the Esomeprazole Magnesium Price is obtained through a variety of data sources. The Esomeprazole Magnesium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Esomeprazole Magnesium

Synonyms

Omeprazole magnesium, 161973-10-0, Prilosec otc, H 168/68 magnesium, 95382-33-5, Omeprazole (as magnesium)

Cas Number

95382-33-5

Unique Ingredient Identifier (UNII)

426QFE7XLK

About Esomeprazole Magnesium

The S-isomer of omeprazole.

Esomeprazole Manufacturers

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.

Esomeprazole Suppliers

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.

Esomeprazole JDMF

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.

Esomeprazole Manufacturers | Traders | Suppliers

Esomeprazole Manufacturers, Traders, Suppliers 1
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Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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