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

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01 Dongbang FTL Co., Ltd. (1)

02 Jeil Pharmaceutical Co., Ltd. (2)

03 MSD International GmbH (Puerto Rico Branch) LLC. (1)

04 Mylan Laboratories Limited (Unit-1) (1)

05 [Partial process consignment manufacturing (manufacturing requester)] (Division process manufacturing) Dasan Pharmaceutical Co., Ltd. @Myungmoon Bio Co., Ltd. @[Starting material manufacturing site] Hebei Baiqi Pharmaceutical Co., Ltd. (1)

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01 Ace Biopharm Co., Ltd. (1)

02 Dasan Pharmaceutical Co., Ltd. (1)

03 Dongbang FTL Co., Ltd. (1)

04 Jeil Pharmaceutical Co., Ltd. (2)

05 MSD Korea Co., Ltd. (1)

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01 Sitagliptin Phosphate (5)

02 Sitagliptin camsylate (1)

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01 South Korea (4)

02 U.S.A (2)

URL Supplier Web Content
Dasan Pharmaceutical Co., Ltd.
2015-03-03
Wed2243-8-ND
[Partial process consignm...
South Korea
[Partial process consignm...
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Dongbang FTL Co., Ltd.
2020-07-14
1731-18-ND
Dongbang FTL Co., Ltd.
South Korea
78, Jaekongdan 4-gil, Hya...
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Jeil Pharmaceutical Co., Ltd.
2018-08-27
1668-22-ND
Jeil Pharmaceutical Co., ...
South Korea
7, Cheongganggachang-ro, ...
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Jeil Pharmaceutical Co., Ltd.
2017-06-27
1668-20-ND
Jeil Pharmaceutical Co., ...
South Korea
7, Cheongganggachang-ro, ...
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MSD Korea Co., Ltd.
2007-08-31
906-3-ND
MSD International GmbH (P...
U.S.A
Road #2, Kilometer 56.7, ...
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Ace Biopharm Co., Ltd.
2015-01-06
Number 5217-4-ND
Mylan Laboratories Limite...
India
Sy.No.10, Gaddapotharam(V...
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Looking for 1269630-53-6 / Sitagliptin Phosphate API manufacturers, exporters & distributors?

Sitagliptin Phosphate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Sitagliptin Phosphate

Synonyms

654671-78-0, Sitagliptin (phosphate), Mk-0431, Chembl393336, 494p4635i6, Mk0431

Cas Number

1269630-53-6

Unique Ingredient Identifier (UNII)

494P4635I6

About Sitagliptin Phosphate

A pyrazine-derived DIPEPTIDYL-PEPTIDASE IV INHIBITOR and HYPOGLYCEMIC AGENT that increases the levels of the INCRETIN hormones GLUCAGON-LIKE PEPTIDE-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). It is used in the treatment of TYPE 2 DIABETES.

Sitagliptin Phosphate Manufacturers

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

Sitagliptin Phosphate Suppliers

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

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

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

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

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

Sitagliptin Phosphate Manufacturers | Traders | Suppliers

Sitagliptin Phosphate Manufacturers, Traders, Suppliers 1
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We have 5 companies offering Sitagliptin Phosphate

Get in contact with the supplier of your choice:

  1. Dasan Pharmaceutical
  2. Dongbang FTL
  3. Jeil Pharmaceutical Co., Ltd
  4. Merck & Co
  5. Viatris
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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