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

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01 Polpharma (1)

02 Dr. Reddy's Laboratories (1)

03 Metrochem API Private Limited (1)

04 Aarti Pharmalabs (1)

05 Neuland Laboratories (1)

06 Minakem (formerly Delmar Chemicals) (1)

07 Medichem S.A (1)

08 ALP Pharm (1)

09 Actavis Inc (1)

10 Alembic Pharmaceuticals Limited (1)

11 Amoli Organics (1)

12 Apotex Pharmachem (1)

13 Aurobindo Pharma Limited (1)

14 Biocon (1)

15 Changzhou Pharmaceutical Factory (1)

16 Glenmark Life Sciences (1)

17 HEC Pharm (1)

18 HONOUR LAB LTD (1)

19 Hikal (1)

20 Indoco Remedies Limited (1)

21 Jiangxi Synergy Pharmaceutical (1)

22 Jubilant Generics (1)

23 Lee Pharma (1)

24 MSN Laboratories (2)

25 Macleods Pharmaceuticals Limited (1)

26 Micro Labs Limited (1)

27 Morepen Laboratories (3)

28 Natco Pharma (1)

29 Ningbo Menovo Pharmaceutical (1)

30 Optimus Pharma (1)

31 SINTENOVO, S.A. DE C.V. (1)

32 SMS Pharmaceuticals (1)

33 ScinoPharm Taiwan, Ltd (2)

34 Sigmapharm Laboratories, LLC (1)

35 Srini Pharmaceuticals (2)

36 Sun Pharmaceutical Industries Limited (1)

37 Teva API (1)

38 Unichem Laboratories Limited (1)

39 Viatris (1)

40 ZCL Chemicals Limited (1)

41 Zhejiang Hisun Pharmaceutical (1)

42 Zhejiang Huahai Pharmaceutical (1)

43 Zhejiang Supor Pharmaceuticals Co., LTD (1)

44 Zydus Lifesciences (1)

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01 5,6-DIHYDRO-3-(4-MORPHOLINYL)-1-[4-(2-OXO-1-PIPERIDINYL)PHENYL]-2(1H)-PYRIDINONE (AXBN20) (1)

02 APIXABAN (43)

03 APIXABAN AMORPHOUS (1)

04 APIXABAN AMORPHOUS (6.58%) (1)

05 APIXABAN FORM H3 (1)

06 APIXABAN NON-STERILE BULK DRUG SUBSTANCE (1)

07 APIXABAN [ROUTE CODE "AX"] (1)

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01 Canada (2)

02 China (8)

03 India (30)

04 Ireland (1)

05 Israel (1)

06 Mexico (1)

07 Poland (1)

08 Spain (1)

09 Taiwan (2)

10 U.S.A (2)

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01 Active (45)

02 Inactive (4)

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01 Complete (27)

02 Blank (22)

30336
Active
2016-03-14
Complete
2016-08-15
2016-03-28
II
Minakem Delmar

Iran Expo

Not Confirmed

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URL Supplier Web Content
29660
Active
2015-09-30
Complete
2015-12-18
2014-12-24
II
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URL Supplier Web Content
28009
Active
2014-02-26
Complete
2015-11-13
2015-09-23
II
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URL Supplier Web Content
29667
Active
2015-09-02
Complete
2015-12-18
2015-09-25
II
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Looking for 503612-47-3 / Apixaban API manufacturers, exporters & distributors?

Apixaban manufacturers, exporters & distributors 1

15

PharmaCompass offers a list of Apixaban 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 Apixaban manufacturer or Apixaban supplier for your needs.

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

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

API | Excipient name

Apixaban

Synonyms

503612-47-3, Eliquis, Bms-562247, Bms-562247-01, Bms 562247-01, 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1h-pyrazolo[3,4-c]pyridine-3-carboxamide

Cas Number

503612-47-3

Unique Ingredient Identifier (UNII)

3Z9Y7UWC1J

About Apixaban

Apixaban is an orally active inhibitor of coagulation factor Xa with anticoagulant activity. Apixaban directly inhibits factor Xa, thereby interfering with the conversion of prothrombin to thrombin and preventing formation of cross-linked fibrin clots.

Apixaban Manufacturers

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

Apixaban Suppliers

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

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

Apixaban USDMF

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

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

click here to find a list of Apixaban 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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