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List of Drug Master Files (KDMF) for Rivaroxaban Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Pharmaceutical Works Polpharma S.A. (2)

02 Interquim, S.A. (1)

03 Dr. Reddy's Laboratories Limited (1)

04 Neuland Laboratories Limited (Unit-II) (2)

05 Medichem Manufacturing (Malta) Ltd. (2)

06 Alembic Pharmaceuticals Limited (11)

07 Assia Chemical Industries Ltd. (Teva-Tech Site) (1)

08 Dijia Pharmaceutical Group Co., Ltd (1)

09 Dongbang FTL Co., Ltd. (1)

10 HLGnomics Co., Ltd. (1)

11 Hanseochem Co., Ltd. (1)

12 Hunan Jiudian Hongyang Pharmaceutical.Co.,Ltd (1)

13 Ildong Pharmaceutical Co., Ltd. (1)

14 Jeil Pharmaceutical Co., Ltd. (1)

15 Jiangxi Synergy Pharmaceutical Co., Ltd (3)

16 Kyungbo Pharmaceutical Co., Ltd. (1)

17 LUPIN LIMITED (1)

18 Piramal Pharma Limited (1)

19 Symed Labs Ltd (Unit-I) (1)

20 Topharman Shandong Co., Ltd. (1)

21 ZCL Chemicals Limited (1)

22 [Processes other than micronization (rivaroxaban manufacturing)] Bayer AG@[micronization manufacturing plant ①] Bayer AG@[micronization manufacturing plant ②] Bayer HealthCare Manufacturing Srl (1)

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01 Aging Life Science Co., Ltd. (1)

02 Bayer Korea Co., Ltd. (1)

03 Daesin Pharmaceutical Co., Ltd. (1)

04 Dongbang FTL Co., Ltd. (1)

05 Farmirae Co., Ltd. (1)

06 HLGnomics Co., Ltd. (1)

07 Hallym Pharmaceutical Co., Ltd. (1)

08 Hanmi Pharmaceutical Co., Ltd. (1)

09 Hanseochem Co., Ltd. (1)

10 Hanyoung Farm Co., Ltd. (1)

11 Hwail Pharmaceutical Co., Ltd. (3)

12 IMCD Korea Co., Ltd. (2)

13 Ildong Pharmaceutical Co., Ltd. (1)

14 Jeil Pharmaceutical Co., Ltd. (1)

15 Kyungbo Pharmaceutical Co., Ltd. (1)

16 Kyungdong Pharmaceutical Co., Ltd. (1)

17 Leaders Bio Co., Ltd. (1)

18 Leesung International Co., Ltd. (2)

19 Lihu Healthcare Co., Ltd. (1)

20 Masung LS Co., Ltd. (1)

21 Mpeak Korea Co., Ltd. (2)

22 Otran Farm Korea Co., Ltd. (2)

23 SG Biochem Co., Ltd. (1)

24 SK Chemicals Co., Ltd. (1)

25 Samo Pharmaceutical Co., Ltd. (1)

26 Seongui Bio Co., Ltd. (1)

27 Sungjin Exim Co., Ltd. (1)

28 Sungwoo Chemical Co., Ltd. (1)

29 Taewang Products Co., Ltd. (1)

30 Wooshin Rabotachi Co., Ltd. (1)

31 Yuyu Pharmaceutical Co., Ltd. (1)

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01 Micronized Rivaroxaban Micronized Rivaroxaban Micronized Rivaroxaban (1)

02 Micronized rivaroxaban (5)

03 Rivaroxaban (30)

04 Rivaroxaban (micronized) (1)

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01 China (6)

02 Germany (1)

03 India (16)

04 Israel (1)

05 Malaysia (1)

06 Poland (2)

07 South Korea (6)

08 Spain (3)

09 U.S.A (1)

Wooshin Rabotachi Co., Ltd.
2020-03-18
Number 172-1-ND(1)
Pharmaceutical Works Polp...
Poland
19. Pelplinska Str, 83-20...
NA Not Available For Sales
Seongui Bio Co., Ltd.
2018-12-28
Number 259-8-ND
Interquim, S.A.
Spain
c/ Joan Buscalla, 10 E-08...
Farmirae Co., Ltd.
2021-05-18
Number 574-19-ND
Dr. Reddy's Laboratories ...
India
CTO-VI, APIIC Industrial ...
SG Biochem Co., Ltd.
2021-07-13
Number 434-11-ND(1)
Neuland Laboratories Limi...
India
Plot No. 92-94, 257-259 I...
Yuyu Pharmaceutical Co., Ltd.
2019-10-10
Number 133-7-ND(1)
Medichem Manufacturing (M...
Malta
HF 61 Hal Far Industrial ...
IMCD Korea Co., Ltd.
2019-12-04
Number 172-1-ND
Pharmaceutical Works Polp...
Poland
19, Pelplinska Str. 83-20...
Aging Life Science Co., Ltd.
2020-06-22
Number 434-11-ND
Neuland Laboratories Limi...
India
Plot No. 92-94, 257-259 I...
Sungjin Exim Co., Ltd.
2017-02-22
Number 133-7-ND
Medichem Manufacturing (M...
Malta
HF-61 Hal Far Industrial ...
URL Supplier Web Content
Daesin Pharmaceutical Co., Ltd.
2023-07-11
Number 331-23-ND(2)
Jiangxi Synergy Pharmaceu...
China
Jiangxi Fengxin Industria...
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Mpeak Korea Co., Ltd.
2023-12-11
Wed812-22-ND
ZCL Chemicals Limited
India
Plot No. 3102/B GIDC, Ind...
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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 KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Rivaroxaban Drug Master File in Korea (Rivaroxaban KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rivaroxaban. The MFDS reviews the Rivaroxaban KDMF as part of the drug registration process and uses the information provided in the Rivaroxaban KDMF to evaluate the safety and efficacy of the drug.

After submitting a Rivaroxaban KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Rivaroxaban API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Rivaroxaban suppliers with KDMF 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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