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ABOUT THIS PAGE
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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.
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.
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.
A Telbivudine DMF (Drug Master File) is a document detailing the whole manufacturing process of Telbivudine active pharmaceutical ingredient (API) in detail. Different forms of Telbivudine DMFs exist exist since differing nations have different regulations, such as Telbivudine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Telbivudine DMF submitted to regulatory agencies in the US is known as a USDMF. Telbivudine USDMF includes data on Telbivudine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Telbivudine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Telbivudine suppliers with USDMF on PharmaCompass.
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 Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Telbivudine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Telbivudine GMP manufacturer or Telbivudine GMP API supplier for your needs.
A Telbivudine CoA (Certificate of Analysis) is a formal document that attests to Telbivudine's compliance with Telbivudine specifications and serves as a tool for batch-level quality control.
Telbivudine CoA mostly includes findings from lab analyses of a specific batch. For each Telbivudine CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Telbivudine may be tested according to a variety of international standards, such as European Pharmacopoeia (Telbivudine EP), Telbivudine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Telbivudine USP).
