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

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01 Pharmaceutical Works Polpharma S.A. (2)

02 Dr. Reddy's Laboratories Limited (2)

03 Neuland Laboratories Limited (1)

04 Medichem Manufacturing (Malta) Ltd. (1)

05 Alembic Pharmaceuticals Limited (1)

06 Apotex Pharmachem India Pvt. Ltd. (1)

07 Asia Chemical Industries Ltd. (1)

08 CTX Lifesciences Pvt. Ltd. (1)

09 Dongbang FTL Co., Ltd. (1)

10 Glenmark Life Sciences Limited (4)

11 Hanseochem Co., Ltd. (1)

12 Honor Lab Limited (Unit-III) (1)

13 Jiangxi Synergy Pharmaceutical Co., Ltd (1)

14 Korea Biochem Pharmaceutical Co., Ltd. (1)

15 Kyungbo Pharmaceutical Co., Ltd. (1)

16 M/s. Honor Lab Limited (Unit-III) (2)

17 Natco Pharma Limited (1)

18 RUYUAN HEC PHARM Co., Ltd (1)

19 SK Biotek Ireland Limited@[Micronization Plant ①] Jetpharma SA@[Micronization Plant ②]Catalent Micron Technologies Limited (1)

20 Samjin Pharmaceutical Co., Ltd. (1)

21 Siegfried Evionnaz SA@Jetpharma SA (1)

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01 Ace Biopharm Co., Ltd. (1)

02 Aging Life Science Co., Ltd. (2)

03 BMS Korea Pharmaceutical Co., Ltd. (2)

04 Bahnsen Co., Ltd. (1)

05 Dongbang FTL Co., Ltd. (1)

06 Farmirae Co., Ltd. (2)

07 Hanseochem Co., Ltd. (1)

08 Hwail Pharmaceutical Co., Ltd. (1)

09 IMCD Korea Co., Ltd. (1)

10 Inseong Trading Co., Ltd. (1)

11 Korea Biochem Pharmaceutical Co., Ltd. (1)

12 Kyungbo Pharmaceutical Co., Ltd. (1)

13 Leesung International Co., Ltd. (1)

14 Mpeak Korea Co., Ltd. (1)

15 NBP Healthcare Co., Ltd. (1)

16 Pharmapia Co., Ltd. (1)

17 SG Biochem Co., Ltd. (1)

18 Saehan Pharmaceutical Co., Ltd. (1)

19 Samjin Pharmaceutical Co., Ltd. (1)

20 Samo Pharmaceutical Co., Ltd. (1)

21 Sampoong Pharmachem Co., Ltd. (1)

22 Sungjin Exim Co., Ltd. (1)

23 Sungwoo Chemical Co., Ltd. (1)

24 Wooshin Rabotachi Co., Ltd. (1)

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01 Apixaban (26)

02 Apixaban (micronized) (1)

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01 Canada (1)

02 China (2)

03 India (13)

04 Israel (1)

05 Poland (2)

06 South Korea (5)

07 Spain (1)

08 Switzerland (1)

09 U.S.A (1)

Wooshin Rabotachi Co., Ltd.
2020-09-04
Number 172-5-ND(1)
Pharmaceutical Works Polp...
Poland
19. Pelplinska Str, 83-20...
Farmirae Co., Ltd.
2019-01-17
Number 574-12-ND
Dr. Reddy's Laboratories ...
India
CTO-SEZ Process Unit-01, ...
Aging Life Science Co., Ltd.
2021-11-04
Number 434-42-ND
Neuland Laboratories Limi...
India
Plot No. 92-94, 257-259 I...
Sungjin Exim Co., Ltd.
2019-11-26
Wed133-10-ND
Medichem Manufacturing (M...
Malta
HF-61 Hal Far Industrial ...
IMCD Korea Co., Ltd.
2020-08-05
Number 172-5-ND
Pharmaceutical Works Polp...
Poland
19. Pelplinska Str, 83-20...
Farmirae Co., Ltd.
2018-01-30
Number 574-11-ND
Dr. Reddy's Laboratories ...
India
CTO-SEZ Process Unit-01, ...
URL Supplier Web Content
NBP Healthcare Co., Ltd.
2023-09-20
Number 55-4-ND(3)
Glenmark Life Sciences Li...
India
Plot No 3109, GIDC Indust...
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Sampoong Pharmachem Co., Ltd.
2023-12-27
Number 582-14-ND
RUYUAN HEC PHARM Co., Ltd
China
Xiaba Development Zone, R...
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Ace Biopharm Co., Ltd.
2023-04-25
Wed289-16-ND
Jiangxi Synergy Pharmaceu...
China
699, Changle Ave, Jiangxi...
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Korea Biochem Pharmaceutical Co., Ltd.
2022-09-21
2152-18-ND
Korea Biochem Pharmaceuti...
South Korea
204 Sandan-gil, Jeonui-my...
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Looking for 503612-47-3 / Apixaban API manufacturers, exporters & distributors?

Apixaban manufacturers, exporters & distributors 1

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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 KDMF

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

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

After submitting a Apixaban 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 Apixaban API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Apixaban 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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