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List of Drug Master Files (DMF) of Rivaroxaban 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 Neuland Laboratories (1)

04 Megafine Pharma (P) Limited (1)

05 USV Private Limited (1)

06 Medichem S.A (1)

07 Alembic Pharmaceuticals Limited (1)

08 Ami Lifesciences Private Limited (1)

09 Amoli Organics (1)

10 Apotex Pharmachem (1)

11 Aurobindo Pharma Limited (1)

12 Bayer AG (2)

13 Biocon (1)

14 Changzhou Pharmaceutical Factory (1)

15 Charioteer (1)

16 Chengda Pharmaceuticals (1)

17 Cipla (1)

18 Fuxin Long Rui Pharmaceutical (1)

19 Glenmark Life Sciences (1)

20 HEC Pharm (1)

21 Hetero Drugs (1)

22 Hikal (1)

23 Indoco Remedies Limited (1)

24 Innovare Labs (1)

25 Intas Pharmaceuticals (1)

26 Jiangxi Synergy Pharmaceutical (1)

27 Johnson & Johnson Innovative Medicine (1)

28 Jubilant Generics (1)

29 Lee Pharma (1)

30 Lupin Ltd (1)

31 MSN Laboratories (1)

32 Macleods Pharmaceuticals Limited (1)

33 Micro Labs Limited (1)

34 Morepen Laboratories (1)

35 Optimus Pharma (2)

36 Piramal Pharma Solutions (1)

37 Raks Pharma (1)

38 SMS Pharmaceuticals (1)

39 Srini Pharmaceuticals (1)

40 Symed Labs (1)

41 TOPHARMAN SHANDONG CO LTD (1)

42 Taro Pharmaceutical Industries (1)

43 Teva API (1)

44 Tianjin Weijie Pharmaceutical Co., Ltd. (1)

45 UQUIFA (1)

46 Unichem Laboratories Limited (1)

47 Vasudha Pharma Chem (1)

48 Viatris (1)

49 Viwit Pharmaceuticals Limited (1)

50 YUNG ZIP CHEMICAL INDUSTRIAL (1)

51 ZCL Chemicals Limited (1)

52 Zhejiang Guobang Pharmaceutical (1)

53 Zhejiang Huahai Pharmaceutical (1)

54 Zhejiang Jingxin Pharmaceutical Co. ltd (1)

55 Zhejiang Supor Pharmaceuticals Co., LTD (1)

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01 4-(4-AMINOPHENYL) MORPHOLIN-3-ONE [RIVAROXABAN INTERMEDIATE, (PROCESS-1)] (1)

02 RIVAROXABAN (39)

03 RIVAROXABAN (DRUG SUBSTANCE, NON-STERILE) (1)

04 RIVAROXABAN (MICRONIZED) DRUG SUBSTANCE (1)

05 RIVAROXABAN (NON-STERILE DRUG SUBSTANCE) (1)

06 RIVAROXABAN 10 MG FILM COATED TABLETS (1)

07 RIVAROXABAN COATED TABLETS, 10 MG (1)

08 RIVAROXABAN FORM- I (MICRONIZED) (1)

09 RIVAROXABAN MICRONIZED (1)

10 RIVAROXABAN USP (7)

11 RIVAROXABAN USP (MICRONISED) (1)

12 RIVAROXABAN USP [ROUTE CODE "RR") (1)

13 RIVAROXABAN, NON-STERILE BULK DRUG SUBSTANCE (1)

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01 Canada (1)

02 China (13)

03 Germany (2)

04 India (32)

05 Israel (1)

06 Poland (1)

07 Spain (2)

08 Taiwan (1)

09 U.S.A (4)

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01 Active (57)

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01 Complete (33)

02 Blank (24)

30609
Active
2016-09-28
Complete
2022-05-13
2022-04-27
II
URL Supplier Web Content
21581
Active
2008-07-23
N/A
II
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URL Supplier Web Content
21580
Active
2008-07-23
N/A
II
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URL Supplier Web Content
21592
Active
2008-07-24
N/A
II
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URL Supplier Web Content
27807
Active
2013-12-31
Complete
2014-12-01
2014-10-08
II
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PHARMACOMPASS
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Looking for 366789-02-8 / Rivaroxaban API manufacturers, exporters & distributors?

Rivaroxaban manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Rivaroxaban

Synonyms

366789-02-8, Xarelto, Bay 59-7939, (s)-5-chloro-n-((2-oxo-3-(4-(3-oxomorpholino)phenyl)oxazolidin-5-yl)methyl)thiophene-2-carboxamide, Bay59-7939, Bay-59-7939

Cas Number

366789-02-8

Unique Ingredient Identifier (UNII)

9NDF7JZ4M3

About Rivaroxaban

A morpholine and thiophene derivative that functions as a FACTOR XA INHIBITOR and is used in the treatment and prevention of DEEP-VEIN THROMBOSIS and PULMONARY EMBOLISM. It is also used for the prevention of STROKE and systemic embolization in patients with non-valvular ATRIAL FIBRILLATION, and for the prevention of atherothrombotic events in patients after an ACUTE CORONARY SYNDROME.

Rivaroxaban Manufacturers

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

Rivaroxaban Suppliers

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

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

Rivaroxaban USDMF

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

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

click here to find a list of Rivaroxaban 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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