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

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01 Pfizer Ireland Pharmaceuticals (2)

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01 MSD Korea Co., Ltd. (2)

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01 Ertugliflozin L-pyroglutamic acid (2)

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01 U.S.A (2)

URL Supplier Web Content
MSD Korea Co., Ltd.
2018-04-10
Wed90-24-ND
Pfizer Ireland Pharmaceut...
Ireland
Ringaskiddy API Plant, Ri...
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URL Supplier Web Content
MSD Korea Co., Ltd.
2018-04-10
Wed90-25-ND
Pfizer Ireland Pharmaceut...
Ireland
Ringaskiddy API Plant, Ri...
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Looking for 1210344-57-2 / Ertugliflozin API manufacturers, exporters & distributors?

Ertugliflozin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ertugliflozin

Synonyms

1210344-57-2, Pf-04971729, Steglatro, Pf04971729, (1s,2s,3s,4r,5s)-5-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol, Chembl1770248

Cas Number

1210344-57-2

Unique Ingredient Identifier (UNII)

6C282481IP

About Ertugliflozin

Ertugliflozin belongs to the class of potent and selective inhibitors of the sodium-dependent glucose cotransporters (SGLT), more specifically the type 2 which is responsible for about 90% of the glucose reabsorption from glomerulus. This drug was developed under the collaboration of Merck and Pfizer. It was FDA approved as monotherapy and in combination with sitagliptin or metformin hydrochloride on December 22, 2017.

Ertugliflozin Manufacturers

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

Ertugliflozin Suppliers

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

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

Ertugliflozin KDMF

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

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

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

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

Ertugliflozin Manufacturers | Traders | Suppliers

Ertugliflozin Manufacturers, Traders, Suppliers 1
13

We have 1 companies offering Ertugliflozin

Get in contact with the supplier of your choice:

  1. Pfizer Inc
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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