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

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01 Pharmaceutical Works Polpharma S.A. (1)

02 Dr. Reddy's Laboratories Limited (1)

03 Alembic Pharmaceuticals Limited (API Unit-III) (1)

04 Biocon Limited (1)

05 Dasan Pharmaceutical Co., Ltd. @Yoilpharm Tech Co., Ltd. (1)

06 Glenmark Life Sciences Limited (1)

07 HONOUR LAB LIMITED(Unit-III) (1)

08 Hanmi Fine Chemical Co., Ltd. @[Dapagliflozin Manufacturing Company] Wisdom Pharmaceutical Co., Ltd. (1)

09 Hunan Jiudian Hongyang Pharmaceutical Co., Ltd@ST ​​Pharm Co., Ltd. (1)

10 Kookjeon Pharmaceutical Co., Ltd. @[Starting Material Manufacturing Site] Lee Pharma Limited (1)

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

12 Kyungdong Pharmaceutical Co., Ltd. (1)

13 Lee Pharma Limited (1)

14 Lupin Limited@[Dapagliflozin L-Proline Manufacturer]SMS Pharmaceuticals Ltd (1)

15 MSN Laboratories Private Limited (1)

16 ST Pharm Co., Ltd. (1)

17 Sun Pharmaceutical Industries Limited@Sun Pharmaceutical Industries Limited (1)

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01 Dasan Pharmaceutical Co., Ltd. (1)

02 Farmirae Co., Ltd. (2)

03 Hanmi Fine Chemical Co., Ltd. (1)

04 Hiple Co., Ltd. (1)

05 Kookjeon Pharmaceutical Co., Ltd. (2)

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

07 Kyungdong Pharmaceutical Co., Ltd. (1)

08 Leesung International Co., Ltd. (1)

09 Masung LS Co., Ltd. (1)

10 Mpeak Korea Co., Ltd. (1)

11 ST Pharm Co., Ltd. (2)

12 Samo Pharmaceutical Co., Ltd. (1)

13 Sungwoo Chemical Co., Ltd. (1)

14 UNUST Co., Ltd. (1)

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01 Dapagliflozin (10)

02 Dapagliflozin Formate (2)

03 Dapagliflozin butanediol hydrate (1)

04 Dapagliflozin citrate (2)

05 Dapagliflozinbis L-proline (2)

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01 China (1)

02 India (9)

03 Poland (1)

04 South Korea (6)

Hiple Co., Ltd.
2019-09-26
Number 30-3-ND
Pharmaceutical Works Polp...
Poland
19 Pelplinska Str., 83-20...
Farmirae Co., Ltd.
2019-04-03
Number 574-13-ND
Dr. Reddy's Laboratories ...
India
CTO-SEZ Process Unit-01, ...
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Dasan Pharmaceutical Co., Ltd.
2024-01-23
2243-14-ND
Dasan Pharmaceutical Co.,...
South Korea
342 Deogamsan-ro, Dogo-my...
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Hanmi Fine Chemical Co., Ltd.
2020-04-08
1444-10-ND
Hanmi Fine Chemical Co., ...
South Korea
57 Gyeongje-ro, Siheung-s...
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ST Pharm Co., Ltd.
2023-09-22
1301-9-ND
Hunan Jiudian Hongyang Ph...
China
Tongguan Circular Economy...
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Kookjeon Pharmaceutical Co., Ltd.
2023-09-21
2520-45-ND
Kookjeon Pharmaceutical C...
South Korea
8 Balangongdan-ro, Hyangn...
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Masung LS Co., Ltd.
2023-04-03
Wed163-30-ND
Lee Pharma Limited
India
Survey No. 10/Gl, Gaddapo...
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UNUST Co., Ltd.
2019-10-29
Number 496-25-ND
Lupin Limited@[Dapagliflo...
India
Plot No : 130, Road No.11...
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ST Pharm Co., Ltd.
2020-10-29
1301-8-ND
ST Pharm Co., Ltd.
South Korea
171 Haean-ro, Danwon-gu, ...
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Farmirae Co., Ltd.
2020-11-17
Number 574-17-ND
Sun Pharmaceutical Indust...
India
Plot No. Z-15, Dahej SEZ,...
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Looking for 461432-26-8 / Dapagliflozin API manufacturers, exporters & distributors?

Dapagliflozin manufacturers, exporters & distributors 1

20

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

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

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

API | Excipient name

Dapagliflozin

Synonyms

461432-26-8, Bms-512148, Forxiga, Bms 512148, (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol, Dagagflozin

Cas Number

461432-26-8

Unique Ingredient Identifier (UNII)

1ULL0QJ8UC

About Dapagliflozin

Dapagliflozin is a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor with antihyperglycemic activity. Dapagliflozin selectively and potently inhibits SGLT2 compared to SGLT1, which is the cotransporter of glucose in the gut.

Dapagliflozin Manufacturers

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

Dapagliflozin Suppliers

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

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

Dapagliflozin KDMF

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

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

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

click here to find a list of Dapagliflozin suppliers with KDMF on PharmaCompass.

Dapagliflozin Manufacturers | Traders | Suppliers

Dapagliflozin Manufacturers, Traders, Suppliers 1
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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