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

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01 Dr. Reddy's Laboratories Limited (2)

02 Benechim SRL (2)

03 Biocon Limited (2)

04 Honor Lab Limited (3)

05 Honor Lab Limited Unit III (1)

06 Honor Lab Limited Unit-III (1)

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

08 MSN Pharmachem Private Limited (1)

09 Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (1)

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

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

03 Farmirae Co., Ltd. (2)

04 Kookjeon Pharmaceutical Co., Ltd. (1)

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

06 Leesung International Co., Ltd. (1)

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

08 Pharma Solution Co., Ltd. (1)

09 Pharmapia Co., Ltd. (1)

10 Samo Pharmaceutical Co., Ltd. (2)

11 Seongui Bio Co., Ltd. (1)

12 Shinil Pharmaceutical Co., Ltd. (1)

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01 Sitagliptin Hydrochloride (1)

02 Sitagliptin hydrochloride (2)

03 Sitagliptin hydrochloride hydrate (11)

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01 Belgium (2)

02 China (1)

03 India (10)

04 South Korea (1)

Farmirae Co., Ltd.
2021-11-30
Number 574-20-ND
Dr. Reddy's Laboratories ...
India
CTO-SEZ Process Unit-01, ...
URL Supplier Web Content
Donggu Bio Pharmaceutical Co., Ltd.
2022-12-21
Wed207-55-ND(1)
Benechim SRL
Belgium
Rue Rene Magritte 163 Les...
Moehs Benechin CB

RDD 2024

Not Confirmed

envelop Contact Supplier
Farmirae Co., Ltd.
2017-12-15
Number 574-7-ND
Dr. Reddy's Laboratories ...
India
Chemical Technical Operat...
URL Supplier Web Content
Samo Pharmaceutical Co., Ltd.
2022-05-26
Wed207-55-ND
Benechim SRL
Belgium
Rue Rene Magritte 163 Les...
Moehs Benechin CB

RDD 2024

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
Pharma Solution Co., Ltd.
2019-08-12
Number 434-10-ND(1)
Biocon Limited
India
Special Economic Zone Plo...
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URL Supplier Web Content
Aging Life Science Co., Ltd.
2019-08-08
Number 434-10-ND
Biocon Limited
India
Special Economic Zone Plo...
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URL Supplier Web Content
Shinil Pharmaceutical Co., Ltd.
2022-11-18
Number 259-7-ND(4)
Honor Lab Limited Unit II...
India
Plot No.4, Hetero Infrast...
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Otran Farm Korea Co., Ltd.
2019-02-01
Number 259-7-ND(3)
Honor Lab Limited
India
Unit-III, Plot No.4, Hete...
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Kookjeon Pharmaceutical Co., Ltd.
2021-12-24
Wed173-32-ND
MSN Pharmachem Private Li...
India
Plot No.: 212/ A,B,C,D, P...
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Samo Pharmaceutical Co., Ltd.
2021-03-25
Wed207-49-ND
Zhejiang Jiuzhou Pharmace...
China
99 waisha Road, Jiaojiang...
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Looking for 1000153-09-2 / Sitagliptin Hydrochloride API manufacturers, exporters & distributors?

Sitagliptin Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Sitagliptin Hydrochloride

Synonyms

486459-71-6, Sitagliptin monohydrochloride, Iel0a0os7e, (3r)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5h-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one;hydrochloride, (r)-3-amino-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8h)-yl)-4-(2,4,5-trifluorophenyl)butan-1-one hydrochloride, 1,2,4-triazolo(4,3-a)pyrazine, 7-((3r)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl)-5,6,7,8-tetrahydro-3-(trifluoromethyl)-, monohydrochloride

Cas Number

1000153-09-2

Unique Ingredient Identifier (UNII)

IEL0A0OS7E

Sitagliptin Hydrochloride Manufacturers

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

Sitagliptin Hydrochloride Suppliers

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

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

Sitagliptin Hydrochloride KDMF

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

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

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

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

Sitagliptin Hydrochloride Manufacturers | Traders | Suppliers

Sitagliptin Hydrochloride Manufacturers, Traders, Suppliers 1
68

We have 7 companies offering Sitagliptin Hydrochloride

Get in contact with the supplier of your choice:

  1. Benechim
  2. Dr. Reddy's Laboratories
  3. Biocon
  4. HONOUR LAB LTD
  5. Korea Biochem Pharm
  6. MSN Laboratories
  7. Zhejiang Jiuzhou Pharmaceutical
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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