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List of Drug Master Files (DMF) of Esomeprazole Magnesium Dihydrate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Minakem (2)

02 Metrochem API Private Limited (2)

03 Dr. Reddy's Laboratories (3)

04 RANBAXY LABORATORIES LIMITED (1)

05 Sun Pharmaceutical Industries Limited (2)

06 Alkem Laboratories (2)

07 Aurobindo Pharma Limited (2)

08 Chromo Laboratories (1)

09 Cipla (2)

10 Everest Organics (1)

11 F.I.S. Fabbrica Italiana Sintetici (3)

12 Glenmark Life Sciences (4)

13 Granules India Limited (2)

14 HEC Pharm (1)

15 Hetero Drugs (5)

16 Jubilant Generics (5)

17 Lee Pharma (1)

18 Lupin Ltd (1)

19 MSN Laboratories (3)

20 Macleods Pharmaceuticals Limited (2)

21 Ningbo Menovo Pharmaceutical (1)

22 Perrigo API India Private Limited (1)

23 Raks Pharma (2)

24 Shouguang Fukang Pharmaceutical Co., Ltd (2)

25 Srini Pharmaceuticals (1)

26 Torrent Pharmaceuticals Limited (2)

27 UQUIFA (1)

28 Vasudha Pharma Chem (1)

29 Viatris (3)

30 ZHEJIANG JINHUA CONBA BIO-PHARM. CO., LTD. (1)

31 Zhejiang Yongtai Technology (1)

32 Zydus Lifesciences (2)

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01 ESOMEPRAZOLE (1)

02 ESOMEPRAZOLE MAGNESIUM (1)

03 ESOMEPRAZOLE MAGNESIUM (AMORPHOUS) USP (1)

04 ESOMEPRAZOLE MAGNESIUM (AMORPHOUS, NON-STERILE BULK DRUG SUBSTANCE) (1)

05 ESOMEPRAZOLE MAGNESIUM AMORPHOUS (PROCESS-2) USP (1)

06 ESOMEPRAZOLE MAGNESIUM AMORPHOUS-USP (1)

07 ESOMEPRAZOLE MAGNESIUM DELAYED - RELEASE PELLETS (1)

08 ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE PELLETS (25.82% W/W) (1)

09 ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE PELLETS (AS 20.94%W/W OF ESOMEPRAZOLE) (1)

10 ESOMEPRAZOLE MAGNESIUM DIHYDRATE (13)

11 ESOMEPRAZOLE MAGNESIUM DIHYDRATE (PROCESS II) (2)

12 ESOMEPRAZOLE MAGNESIUM DIHYDRATE (PROCESS-III) (1)

13 ESOMEPRAZOLE MAGNESIUM DIHYDRATE MICRONIZED AND NON MICRONIZED (1)

14 ESOMEPRAZOLE MAGNESIUM DIHYDRATE NON-STERILE BULK DRUG SUBSTANCE (1)

15 ESOMEPRAZOLE MAGNESIUM DIHYDRATE PROCESS II (1)

16 ESOMEPRAZOLE MAGNESIUM DIHYDRATE USP (4)

17 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (8)

18 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP (10)

19 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, USP (3)

20 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, USP (ROUTE CODE - "ES") (1)

21 ESOMEPRAZOLE MAGNESIUM USP (2)

22 ESOMEPRAZOLE MAGNESIUM USP (AMORPHOUS) (1)

23 ESOMEPRAZOLE MAGNESIUM USP (AMORPHOUS) (PROCESS I) (1)

24 ESOMEPRAZOLE MAGNESIUM USP (AMORPHOUS) (PROCESS II) (1)

25 ESOMEPRAZOLE MAGNESIUM USP (DIHYDRATE) [ROUTE CODE EP] (1)

26 ESOMEPRAZOLE MAGNESIUM USP (TRIHYDRATE) [ROUTE CODE 'EG'] (1)

27 ESOMEPRAZOLE MAGNESIUM USP, NON-STERILE, BULK DRUG SUBSTANCE (1)

28 ESOMEPRAZOLE POTASSIUM (1)

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01 China (6)

02 France (2)

03 India (48)

04 Italy (3)

05 Spain (1)

06 U.S.A (3)

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01 Active (55)

02 Inactive (8)

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01 Complete (39)

02 Blank (24)

URL Supplier Web Content
18559
Inactive
2005-08-03
N/A
II
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URL Supplier Web Content
30175
Active
2016-05-31
Complete
2016-07-28
2016-05-04
II
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URL Supplier Web Content
31094
Active
2016-12-30
Complete
2017-02-27
2016-11-18
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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 Magnesium Dihydrate Manufacturers

A Esomeprazole Magnesium Dihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Esomeprazole Magnesium Dihydrate, including repackagers and relabelers. The FDA regulates Esomeprazole Magnesium Dihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Esomeprazole Magnesium Dihydrate 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 Magnesium Dihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Esomeprazole Magnesium Dihydrate Suppliers

A Esomeprazole Magnesium Dihydrate supplier is an individual or a company that provides Esomeprazole Magnesium Dihydrate active pharmaceutical ingredient (API) or Esomeprazole Magnesium Dihydrate finished formulations upon request. The Esomeprazole Magnesium Dihydrate suppliers may include Esomeprazole Magnesium Dihydrate API manufacturers, exporters, distributors and traders.

click here to find a list of Esomeprazole Magnesium Dihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Esomeprazole Magnesium Dihydrate USDMF

A Esomeprazole Magnesium Dihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Esomeprazole Magnesium Dihydrate active pharmaceutical ingredient (API) in detail. Different forms of Esomeprazole Magnesium Dihydrate DMFs exist exist since differing nations have different regulations, such as Esomeprazole Magnesium Dihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Esomeprazole Magnesium Dihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Esomeprazole Magnesium Dihydrate USDMF includes data on Esomeprazole Magnesium Dihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Esomeprazole Magnesium Dihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Esomeprazole Magnesium Dihydrate suppliers with USDMF on PharmaCompass.

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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