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List of Drug Master Files (KDMF) for Empagliflozin 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@Aragen Life Sciences Private Limited (2)

03 Dr. Reddy's Laboratories Limited@Aragen Life SciencesPrivate Limited (2)

04 Dr. Reddy's Laboratories Limited@GVK Biosciences Private Limited (1)

05 (Excluding micronization process) Bidachem SpA@ (micronization manufacturing plant 1) Boehringer Ingelheim Pharma GmbH & Co. KG@(micronization manufacturing plant 2) Gesellschaft fur Micronisierung mbH (1)

06 @Alembic Pharmaceuticals Limited (1)

07 Alembic Pharmaceuticals Limited (API Unit-III) (2)

08 Boehringer Ingelheim Pharma GmbH & Co. K.G. (1)

09 EMMENNAR PHARMA PRIVATE LIMITED (1)

10 Honor Lab Limited (Unit-III) (7)

11 Honor Lab Limited Unit III (1)

12 JW Pharmaceutical Co., Ltd. (1)

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

14 Laurus Labs Limited(Unit-3)@Laurus Labs Limited(Unit-1) (1)

15 Lee Pharma Limited (3)

16 Lupine Limited (1)

17 MSN Life Sciences Private Limited (2)

18 Mylan Laboratories Limited (1)

19 Teva API India Private Limited (1)

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

02 Boehringer Ingelheim Korea Co., Ltd. (2)

03 Classia Co., Ltd. (1)

04 Daesin Pharmaceutical Co., Ltd. (1)

05 Donggu Bio Pharmaceutical Co., Ltd. (1)

06 Farmirae Co., Ltd. (2)

07 Foosung Bio Co., Ltd. (1)

08 GL Pharma Co., Ltd. (1)

09 IMCD Korea Co., Ltd. (1)

10 JW Pharmaceutical Co., Ltd. (1)

11 Kookjeon Pharmaceutical Co., Ltd. (1)

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

13 Kyungbo Pharmaceutical Co., Ltd. (1)

14 Leesung International Co., Ltd. (2)

15 Lihu Healthcare Co., Ltd. (1)

16 Masung LS Co., Ltd. (1)

17 Mpeak Korea Co., Ltd. (1)

18 Pampia Co., Ltd. (1)

19 Pharmapia Co., Ltd. (4)

20 Samjin Pharmaceutical Co., Ltd. (1)

21 Samo Pharmaceutical Co., Ltd. (1)

22 Sangjin Trading Co., Ltd. (1)

23 Sungwoo Chemical Co., Ltd. (1)

24 Toru Co., Ltd. (1)

25 UNUST Co., Ltd. (1)

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01 Empagliflozin (29)

02 Empagliflozin (amorphous) (2)

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01 Germany (1)

02 India (23)

03 Israel (1)

04 Italy (1)

05 Poland (1)

06 South Korea (3)

07 U.S.A (1)

IMCD Korea Co., Ltd.
2022-01-11
Number 172-9-ND
Pharmaceutical Works Polp...
Poland
19, Pelplinska Street., 8...
Samjin Pharmaceutical Co., Ltd.
2024-01-25
Number 574-15-ND(3)
Dr. Reddy's Laboratories ...
India
CTO-SEZ Process Unit-01, ...
Donggu Bio Pharmaceutical Co., Ltd.
2020-10-29
Number 574-15-ND(1)
Dr. Reddy's Laboratories ...
India
CTO-SEZ Process Unit-01, ...
GL Pharma Co., Ltd.
2022-11-25
Number 574-15-ND(2)
Dr. Reddy's Laboratories ...
India
CTO-SEZ Process Unit-01, ...
Farmirae Co., Ltd.
2021-02-16
Number 574-18-ND
Dr. Reddy's Laboratories ...
India
CTO-SEZ Process Unit-01, ...
Farmirae Co., Ltd.
2020-07-22
Number 574-15-ND
Dr. Reddy's Laboratories ...
India
CTO-SEZ Process Unit-01, ...
URL Supplier Web Content
Pampia Co., Ltd.
2024-01-24
Wed21-10-ND(5)
Honor Lab Limited (Unit-I...
India
Plot No.4, Hetero Infrast...
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Foosung Bio Co., Ltd.
2023-07-11
Wed21-10-ND(4)
Honor Lab Limited Unit II...
India
Plot No.4, Hetero Infrast...
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JW Pharmaceutical Co., Ltd.
2024-01-23
1302-7-ND
JW Pharmaceutical Co., Lt...
South Korea
56 Gyeongje-ro, Siheung-s...
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Toru Co., Ltd.
2023-07-24
Number 163-26-ND(1)
Lee Pharma Limited
India
Survey No. 10/G-1, Gaddap...
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Looking for 864070-44-0 / Empagliflozin API manufacturers, exporters & distributors?

Empagliflozin manufacturers, exporters & distributors 1

46

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

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

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

API | Excipient name

Empagliflozin

Synonyms

864070-44-0, Jardiance, Bi 10773, Bi-10773, Bi10773, Empagliflozin (bi 10773)

Cas Number

864070-44-0

Unique Ingredient Identifier (UNII)

HDC1R2M35U

About Empagliflozin

Empagliflozin is an orally available competitive inhibitor of sodium-glucose co-transporter 2 (SGLT2; SLC5A2) with antihyperglycemic activity. Upon oral administration, empagliflozin selectively and potently inhibits SGLT2 in the kidneys, thereby suppressing the reabsorption of glucose in the proximal tubule. Inhibition of SGLT2 increases urinary glucose excretion by the kidneys, resulting in a reduction of plasma glucose levels in an insulin-independent manner. Inhibition of SGLT2 in the kidneys also suppresses the renal reabsorption of 1,5-anhydroglucitol (1,5AG). This lowers serum 1,5AG and neutrophil 1,5-anhydroglucitol-6-phosphate (1,5AG6P) levels, which may improve neutropenia and neutrophil dysfunction in patients with glycogen storage disease type Ib (GSD Ib). SGLT2, a transport protein exclusively expressed in the proximal renal tubules, mediates approximately 90% of renal glucose reabsorption from tubular fluid.

Empagliflozin Manufacturers

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

Empagliflozin Suppliers

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

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

Empagliflozin KDMF

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

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

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

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

Empagliflozin Manufacturers | Traders | Suppliers

Empagliflozin 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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