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List of Korea Drug Master Files (KDMF) for Glibenclamide Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Samo Pharmaceutical Co., Ltd.
2022-08-01
20220801-209-J-1337
Cambrex Profarmaco Milano...
Italy
Via Curiel, 34 – 20067 ...
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  • TABLET;ORAL - 1.25MG
  • TABLET;ORAL - 2.5MG
  • TABLET;ORAL - 5MG
  • TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 10238-21-8 / Glibenclamide API manufacturers, exporters & distributors?

Glibenclamide manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Glibenclamide

Synonyms

10238-21-8, Glybenclamide, Glynase, Diabeta, Micronase, Daonil

Cas Number

10238-21-8

Unique Ingredient Identifier (UNII)

SX6K58TVWC

About Glibenclamide

An antidiabetic sulfonylurea derivative with actions like those of chlorpropamide

Glibenclamide Manufacturers

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

Glibenclamide Suppliers

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

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

Glibenclamide KDMF

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

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

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

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

Glibenclamide Manufacturers | Traders | Suppliers

Glibenclamide Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Glibenclamide

Get in contact with the supplier of your choice:

  1. Cambrex Corporation
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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