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

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01 Metrochem API Private Limited (1)

02 Dr. Reddy's Laboratories (1)

03 Neuland Laboratories (1)

04 Acebright India Pharma Private Limited (1)

05 Alembic Pharmaceuticals Limited (1)

06 Apotex Pharmachem (1)

07 Aurobindo Pharma Limited (1)

08 Aurore Life Sciences (1)

09 Biocon (1)

10 Changzhou Pharmaceutical Factory (1)

11 Esteve Quimica (1)

12 Glenmark Life Sciences (2)

13 Hetero Drugs (1)

14 Hikal (1)

15 Hisun Pharmaceutical Nantong Co., Ltd. (1)

16 Intas Pharmaceuticals (1)

17 Jiangxi Synergy Pharmaceutical (1)

18 Jubilant Generics (1)

19 Lee Pharma (1)

20 Lupin Ltd (1)

21 MSN Laboratories (2)

22 Micro Labs Limited (1)

23 Optimus Pharma (2)

24 Piramal Pharma Solutions (1)

25 Sichuan Qingmu Pharmaceutical (1)

26 Sichuan Renan Pharmaceutical (1)

27 Solara Active Pharma Sciences (1)

28 Srini Pharmaceuticals (1)

29 Sun Pharmaceutical Industries Limited (1)

30 Teva API (1)

31 Yabao Pharmaceutical Group Co. Ltd (1)

32 Zhejiang Huahai Pharmaceutical (1)

33 Zydus Lifesciences (1)

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01 DABIGATRAN ETEXILATE MESILATE (1)

02 DABIGATRAN ETEXILATE MESYLATE (28)

03 DABIGATRAN ETEXILATE MESYLATE (FORM-I) (1)

04 DABIGATRAN ETEXILATE MESYLATE (MICRO-POWDER) (1)

05 DABIGATRAN ETEXILATE MESYLATE FORM-I (1)

06 DABIGATRAN ETEXILATE MESYLATE [DRUG SUBSTANCE (NON-STERILE)] (1)

07 DABIGATRAN ETEXILATE MESYLATE [ROUTE CODE - "DE"] (1)

08 DABIGATRAN ETEXILATE MESYLATE(PROCESS II) (1)

09 ETHYL 3-(3-AMINO-4-(METHYL AMINO)-N-(PYRIDIN-2-YL) BENZAMIDO PROPANOATE [DABIGATRAN INTERMEDIATE] (1)

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01 Canada (1)

02 China (7)

03 India (25)

04 Israel (1)

05 Spain (1)

06 U.S.A (1)

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01 Active (31)

02 Inactive (5)

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01 Complete (15)

02 Blank (21)

URL Supplier Web Content
27781
Active
2013-12-31
Complete
2014-05-28
2014-03-18
II
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URL Supplier Web Content
28029
Active
2014-03-28
Complete
2014-08-25
2014-03-28
II
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URL Supplier Web Content
28177
Active
2014-08-05
Complete
2014-10-13
2014-08-25
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URL Supplier Web Content
28039
Active
2014-04-11
Complete
2014-10-01
2014-07-03
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URL Supplier Web Content
27037
Active
2013-06-29
Complete
2014-03-24
2014-01-24
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URL Supplier Web Content
28118
Active
2014-04-27
Complete
2014-07-15
2014-04-22
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URL Supplier Web Content
28285
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2014-05-29
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2014-06-24
2014-05-19
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Looking for 872728-81-9 / Dabigatran Etexilate Mesylate API manufacturers, exporters & distributors?

Dabigatran Etexilate Mesylate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Dabigatran Etexilate Mesylate 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 Dabigatran Etexilate Mesylate manufacturer or Dabigatran Etexilate Mesylate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dabigatran Etexilate Mesylate manufacturer or Dabigatran Etexilate Mesylate supplier.

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

API | Excipient name

Dabigatran Etexilate Mesylate

Synonyms

872728-81-9, Pradaxa, Ethyl 3-[[2-[[4-[(z)-n'-hexoxycarbonylcarbamimidoyl]anilino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate;methanesulfonic acid, Dtxsid20236248, Ex-a1966, Mfcd25424070

Cas Number

872728-81-9

About Dabigatran Etexilate Mesylate

A THROMBIN inhibitor which acts by binding and blocking thrombogenic activity and the prevention of thrombus formation. It is used to reduce the risk of stroke and systemic EMBOLISM in patients with nonvalvular atrial fibrillation.

Dabigatran Etexilate Manufacturers

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

Dabigatran Etexilate Suppliers

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

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

Dabigatran Etexilate USDMF

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

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

click here to find a list of Dabigatran Etexilate 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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