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List of Certificates of Suitability (CEPs) for Esomeprazole Active Pharmaceutical Ingredient (API) issued by the EDQM. Original Data: EDQM Database

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01 MINAKEM Dunkerque FR (2)

02 METROCHEM API PRIVATE LIMITED Hyderabad IN (2)

03 DR. REDDY'S LABORATORIES LIMITED Hyderabad IN (3)

04 APITORIA PHARMA PRIVATE LIMITED Hyderabad IN (2)

05 CHROMO LABORATORIES INDIA PRIVATE LIMITED Pashamylaram IN (1)

06 CIPLA LIMITED Mumbai IN (2)

07 EVEREST ORGANICS LIMITED Aroor Village IN (1)

08 F.I.S. - Fabbrica Italiana Sintetici S.p.A. Montecchio Maggiore IT (1)

09 GLENMARK LIFE SCIENCES LIMITED Mumbai IN (1)

10 GRANULES INDIA LIMITED Hyderabad IN (1)

11 HEC PHARM CO., LTD. Yidu City CN (1)

12 HETERO DRUGS LIMITED Hyderabad IN (2)

13 JIANGSU ZHONGBANG PHARMACEUTICAL CO., LTD. Gaochun CN (1)

14 JUBILANT PHARMOVA LIMITED Nanjangud IN (2)

15 KRKA, d.d., Novo mesto Novo mesto SI (1)

16 LEE PHARMA LIMITED Hyderabad IN (2)

17 LUPIN LIMITED Mumbai IN (1)

18 MSN LIFE SCIENCES PRIVATE LIMITED Chandampet Village IN (2)

19 MYLAN LABORATORIES LIMITED Hyderabad IN (2)

20 NIFTY LABS PVT. LTD. Hyderabad IN (1)

21 NINGBO MENOVO PHARMACEUTICAL CO., LTD. Ningbo Hi-Tech District CN (2)

22 NOSCH LABS PRIVATE LIMITED Hyderabad IN (5)

23 PCAS Ecully FR (1)

24 QILU PHARMACEUTICAL CO., LTD. Jinan CN (1)

25 SHOUGUANG FUKANG PHARMACEUTICAL CO., LTD. Shouguang City CN (3)

26 SRINI PHARMACEUTICALS PRIVATE LIMITED Choutuppal IN (1)

27 Sandoz Syntek Ilaç Hammaddeleri Sanayi Ve Ticaret A.S. Istanbul TR (1)

28 Union Quimico Farmaceutica, S.A. (Uquifa S.A.) Barcelona ES (1)

29 VASUDHA PHARMA CHEM LIMITED Hyderabad IN (1)

30 ZHEJIANG HUAYI PHARMACEUTICAL CO., LTD. Yiwu CN (1)

31 ZYDUS LIFESCIENCES LIMITED Vadodara IN (1)

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01 Esomeprazole magnesium dihydrate (16)

02 Esomeprazole magnesium dihydrate, Form A - Micronised (1)

03 Esomeprazole magnesium dihydrate, Form-A (1)

04 Esomeprazole magnesium dihydrate, Micronised 1 and Micronised 2 (1)

05 Esomeprazole magnesium dihydrate, Micronised, non-micronised (1)

06 Esomeprazole magnesium dihydrate, Process II (1)

07 Esomeprazole magnesium dihydrate, Site-II (1)

08 Esomeprazole magnesium dihydrate, Unit IV (1)

09 Esomeprazole magnesium trihydrate (20)

10 Esomeprazole magnesium trihydrate, EMT-2 Process (1)

11 Esomeprazole magnesium trihydrate, ESQ process (1)

12 Esomeprazole magnesium trihydrate, Micronised, non-micronised (1)

13 Esomeprazole magnesium trihydrate, Powder (1)

14 Esomeprazole magnesium trihydrate, Process II (1)

15 Esomeprazole magnesium trihydrate, Unit IV (1)

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01 Austria (1)

02 China (9)

03 France (3)

04 India (31)

05 Italy (1)

06 Slovenia (1)

07 Spain (1)

08 U.S.A (2)

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01 Expired (1)

02 Valid (45)

03 Withdrawn by Holder (3)

URL Supplier Web Content
R1-CEP 2015-320 - Rev 00
Valid
Chemical
2022-08-22
2372
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PHARMACOMPASS
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URL Supplier Web Content
R0-CEP 2021-416 - Rev 00
Valid
Chemical
2022-06-13
2787
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US
PHARMACOMPASS
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URL Supplier Web Content
R0-CEP 2021-169 - Rev 00
Valid
Chemical
2021-07-29
2787
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PHARMACOMPASS
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Looking for 95382-33-5 / Esomeprazole Magnesium API manufacturers, exporters & distributors?

Esomeprazole Magnesium manufacturers, exporters & distributors 1

15

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 CEP

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.

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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