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List of Drug Master Files (KDMF) for Linagliptin 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 Asia Chemical Industries Ltd. (2)

04 Bidachem SpA@Boehringer Ingelheim Pharma GmbH & Co KG (1)

05 Bidachem SpA@Gesellschaft fur Micronisierung mbH (1)

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

07 Boehringer Ingelheim Pharma GmbH & Co. KG@Gesellschaft fur Micronisierung mbH (1)

08 Cambrex Profarmaco Milano Srl (1)

09 Cipla Limited. (1)

10 Glenmark Life Sciences Limited (2)

11 Glenmark Pharmaceuticals Limited (1)

12 Hanseochem Co., Ltd. (1)

13 Harman Finochem Limited (1)

14 Honor Lab Limited (Unit-III) (4)

15 Lee Pharma Limited (3)

16 MSN Pharmachem Private Limited (5)

17 RUYUAN HEC PHARMA Co.,LTD (4)

18 Ruyuan HEC Pharma Co., Ltd. (4)

19 Ruyuan HEC Pharma Co., Ltd.@Kyeongbo Pharmaceutical Co., Ltd. (1)

20 Ruyuan Hec Pharma Co., Ltd. (1)

21 Ruyuan Hec Pharma Co.,Ltd. (5)

22 Zydus Lifesciences Limited (1)

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

02 Aju Pharmaceutical Co., Ltd. (1)

03 Boehringer Ingelheim Korea Co., Ltd. (4)

04 Daebong LS Co., Ltd. (1)

05 Farmirae Co., Ltd. (1)

06 Foosung Bio Co., Ltd. (1)

07 Gapi Bio Co., Ltd. (1)

08 Hanseochem Co., Ltd. (1)

09 Hiple Co., Ltd. (2)

10 Hwail Pharmaceutical Co., Ltd. (1)

11 Kookjeon Pharmaceutical Co., Ltd. (2)

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

13 Kyungbo Pharmaceutical Co., Ltd. (1)

14 Leesung International Co., Ltd. (2)

15 Masung LS Co., Ltd. (1)

16 Mpeak Korea Co., Ltd. (3)

17 Narsha Farm Co., Ltd. (1)

18 Otran Farm Korea Co., Ltd. (1)

19 Pharma Solution Co., Ltd. (1)

20 Pharmapia Co., Ltd. (4)

21 SG Biochem Co., Ltd. (2)

22 Samo Pharmaceutical Co., Ltd. (2)

23 Sampoong Finechem Co., Ltd. (1)

24 Sampoong Pharmachem Co., Ltd. (1)

25 Seongui Bio Co., Ltd. (1)

26 Shinil Pharmaceutical Co., Ltd. (1)

27 Sungwoo Chemical Co., Ltd. (1)

28 Toru Co., Ltd. (1)

29 UNUST Co., Ltd. (1)

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01 Linagliptin (30)

02 Linagliptin (micronized) (10)

03 Linagliptin besylate (1)

04 Micronized linagliptin (2)

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01 China (15)

02 Germany (2)

03 India (19)

04 Israel (2)

05 Italy (2)

06 Poland (1)

07 South Korea (1)

08 U.S.A (1)

Aging Life Science Co., Ltd.
2019-01-11
Number 434-8-ND
Pharmaceutical Works Polp...
Poland
19 Pelplinska Street, 83-...
Farmirae Co., Ltd.
2017-12-15
Number 574-8-ND
Dr. Reddy's Laboratories ...
India
Chemical Technical Operat...
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Samo Pharmaceutical Co., Ltd.
2024-01-31
Wed207-63-ND
Cambrex Profarmaco Milano...
Italy
Via Curiel, 34 – 20067 ...
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Hanseochem Co., Ltd.
2023-01-04
2295-18-ND
Hanseochem Co., Ltd.
South Korea
41 Poseunggongdan-ro, Pos...
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Hiple Co., Ltd.
2023-07-26
Number 582-5-ND(12)
Ruyuan HEC Pharma Co., Lt...
China
Xiaba Development Zone, R...
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Kyungbo Pharmaceutical Co., Ltd.
2023-03-17
1673-53-ND
Ruyuan HEC Pharma Co., Lt...
China
Xiaba Development Zone, R...
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Aju Pharmaceutical Co., Ltd.
2023-09-20
Number 582-5-ND(13)
Ruyuan HEC Pharma Co., Lt...
China
Xiaba Development Zone, R...
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Mpeak Korea Co., Ltd.
2023-01-03
Number 4579-15-ND(3)
Honor Lab Limited (Unit-I...
India
Plot No.4, Hetero Infrast...
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Pharmapia Co., Ltd.
2023-03-08
Wed21-21-ND(1)
Lee Pharma Limited
India
Sy no. 10/G-1, Gaddapotha...
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Foosung Bio Co., Ltd.
2023-08-23
Wed21-21-ND(2)
Lee Pharma Limited
India
Sy no. 10/G-1, Gaddapotha...
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Looking for 668270-12-0 / Linagliptin API manufacturers, exporters & distributors?

Linagliptin manufacturers, exporters & distributors 1

18

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

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

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

API | Excipient name

Linagliptin

Synonyms

668270-12-0, Tradjenta, Bi 1356, Bi-1356, Ondero, Linagliptin (bi-1356)

Cas Number

668270-12-0

Unique Ingredient Identifier (UNII)

3X29ZEJ4R2

About Linagliptin

A purine and quinazoline derivative that functions as an INCRETIN and DIPEPTIDYL-PEPTIDASE IV INHIBTOR. It is used as a HYPOGLYCEMIC AGENT in the treatment of TYPE II DIABETES MELLITUS.

Linagliptin Manufacturers

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

Linagliptin Suppliers

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

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

Linagliptin KDMF

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

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

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

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

Linagliptin Manufacturers | Traders | Suppliers

Linagliptin 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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