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

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01 Lonza AG (1)

02 PLIVA Croatia Ltd (1)

03 SK Biotek Ireland Limited (1)

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01 AstraZeneca Korea Co., Ltd. (2)

02 Samo Pharmaceutical Co., Ltd. (1)

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01 Saxagliptin hydrate (1)

02 Saxagliptin monohydrate (2)

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01 Croatia (1)

02 U.S.A (2)

URL Supplier Web Content
AstraZeneca Korea Co., Ltd.
2019-12-23
Wed248-13-ND
Lonza AG
Switzerland
Lonzastrasse, 3930 Visp, ...
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URL Supplier Web Content
Samo Pharmaceutical Co., Ltd.
2017-06-09
Wed207-34-ND
PLIVA Croatia Ltd
Croatia
10291 Prigorje Brdovecko,...
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AstraZeneca Korea Co., Ltd.
2011-01-10
Number 335-5-ND
SK Biotek Ireland Limited
Ireland
Watery Lane, Swords, Co. ...
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Looking for 361442-04-8 / Saxagliptin API manufacturers, exporters & distributors?

Saxagliptin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Saxagliptin

Synonyms

361442-04-8, Bms-477118, Saxagliptin [inn], Bms 477118, Opc-262, Saxagliptin anhydrous

Cas Number

361442-04-8

Unique Ingredient Identifier (UNII)

8I7IO46IVQ

About Saxagliptin

Saxagliptin Anhydrous is the anhydrous form of saxagliptin, a potent, selective and competitive, cyanopyrrolidine-based, orally bioavailable inhibitor of dipeptidyl peptidase 4 (DPP-4), with hypoglycemic activity. Saxagliptin is metabolized into an, although less potent, active mono-hydroxy metabolite.

Saxagliptin Manufacturers

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

Saxagliptin Suppliers

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

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

Saxagliptin KDMF

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

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

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

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

Saxagliptin Manufacturers | Traders | Suppliers

Saxagliptin Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Saxagliptin

Get in contact with the supplier of your choice:

  1. Lonza Inc & Lonza America Inc
  2. Pliva Hrvatska
  3. SK Biotek
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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