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

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01 Biocon Limited (1)

02 Boehringer Ingelheim Pharma GmbH & Co KG (1)

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01 Darim Biotech Co., Ltd. (1)

02 Novo Nordisk Pharmaceutical Co., Ltd. (1)

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01 repaglinide (2)

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01 Germany (1)

02 India (1)

URL Supplier Web Content
Darim Biotech Co., Ltd.
2021-06-15
20210615-209-J-1027
Biocon Limited
India
20th KM, Hosur Road, Elec...
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URL Supplier Web Content
Novo Nordisk Pharmaceutical Co., Ltd.
2021-10-28
20211028-209-J-1132
Boehringer Ingelheim Phar...
Germany
Binger Strasse 173, D-552...
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Looking for 135062-02-1 / Repaglinide API manufacturers, exporters & distributors?

Repaglinide manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Repaglinide

Synonyms

135062-02-1, Prandin, Novonorm, Gluconorm, Ag-ee 623 zw, Ag-ee 388 zw

Cas Number

135062-02-1

Unique Ingredient Identifier (UNII)

668Z8C33LU

About Repaglinide

Repaglinide is a nonsulfonylurea insulin secretagogue belonging to the melgitinide class with hypoglycemic activity. Repaglinide is rapidly absorbed and has a rapid onset and short duration of action. This agent is metabolized in the liver by CYP2C8 and CYP3A4 and its metabolites are excreted in the bile. Repaglinide has a half-life of one hour.

Repaglinide Manufacturers

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

Repaglinide Suppliers

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

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

Repaglinide KDMF

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

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

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

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

Repaglinide Manufacturers | Traders | Suppliers

Repaglinide Manufacturers, Traders, Suppliers 1
83

We have 2 companies offering Repaglinide

Get in contact with the supplier of your choice:

  1. Biocon
  2. Boehringer Ingelheim GmbH
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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