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

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Flag Switzerland
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Bukwang Pharmaceutical Co., Ltd.
2006-09-08
Number 163-5-ND
[Micronized Manufacturing...
Switzerland
[Micronising Manufactory]...
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Bukwang Pharmaceutical Co., Ltd.
2021-07-23
Number 403-2-ND
Mylan Laboratories Limite...
India
Plot No. 14, 99 & 100, ID...
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Looking for 3424-98-4 / Telbivudine API manufacturers, exporters & distributors?

Telbivudine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Telbivudine

Synonyms

3424-98-4, 2'-deoxy-l-thymidine, Epavudine, L-thymidine, Beta-l-thymidine, Tyzeka

Cas Number

3424-98-4

Unique Ingredient Identifier (UNII)

2OC4HKD3SF

About Telbivudine

A thymidine derivative and antiviral agent that inhibits DNA synthesis by HEPATITIS B VIRUS and is used for the treatment of CHRONIC HEPATITIS B.

Telbivudine Manufacturers

A Telbivudine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Telbivudine, including repackagers and relabelers. The FDA regulates Telbivudine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Telbivudine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Telbivudine Suppliers

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

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

Telbivudine KDMF

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

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

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

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

Telbivudine Manufacturers | Traders | Suppliers

Telbivudine Manufacturers, Traders, Suppliers 1
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We have 2 companies offering Telbivudine

Get in contact with the supplier of your choice:

  1. Novartis Pharmaceuticals Corporation
  2. 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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