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JDMF
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USP
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Australia
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Listed Dossiers
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Data Compilation #PharmaFlow
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API SUPPLIERS
LEBSA- Your strategic API source for niche molecules.
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
KDMF
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
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USDMF
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41441
Submission : 2025-06-29
Status :
Type : II
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China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
Date of Issue : 2024-08-28
Valid Till : 2027-08-27
Written Confirmation Number : SD240048
Address of the Firm : Economic Development Zone, Pingyuan County, Dezhou City, Shandong
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LEBSA- Your strategic API source for niche molecules.
About the Company : Lebsa is an innovative European laboratory that specializes in the synthesis, manufacture and commercialization of APIs with a focus on niche products. With a track record spanning...
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer of Finished Formulat...
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
About the Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include c...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
About the Company : Honour is a leading global CDMO and a trusted manufacturer of specialty chemicals and ingredients. With seven world-class facilities built to meet global safety and quality standar...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
About the Company : Lupin Manufacturing Solutions (LMS), a wholly owned Lupin subsidiary, offers high-quality APIs and end-to-end CDMO services from R&D to commercial scale. Backed by five decades of ...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Letermovir 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 Letermovir manufacturer or Letermovir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Letermovir manufacturer or Letermovir supplier.
PharmaCompass also assists you with knowing the Letermovir API Price utilized in the formulation of products. Letermovir API Price is not always fixed or binding as the Letermovir Price is obtained through a variety of data sources. The Letermovir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Letermovir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Letermovir, including repackagers and relabelers. The FDA regulates Letermovir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Letermovir 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 Letermovir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Letermovir supplier is an individual or a company that provides Letermovir active pharmaceutical ingredient (API) or Letermovir finished formulations upon request. The Letermovir suppliers may include Letermovir API manufacturers, exporters, distributors and traders.
click here to find a list of Letermovir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Letermovir DMF (Drug Master File) is a document detailing the whole manufacturing process of Letermovir active pharmaceutical ingredient (API) in detail. Different forms of Letermovir DMFs exist exist since differing nations have different regulations, such as Letermovir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Letermovir DMF submitted to regulatory agencies in the US is known as a USDMF. Letermovir USDMF includes data on Letermovir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Letermovir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Letermovir 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 Letermovir Drug Master File in Korea (Letermovir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Letermovir. The MFDS reviews the Letermovir KDMF as part of the drug registration process and uses the information provided in the Letermovir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Letermovir 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 Letermovir API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Letermovir suppliers with KDMF on PharmaCompass.
A Letermovir written confirmation (Letermovir WC) is an official document issued by a regulatory agency to a Letermovir manufacturer, verifying that the manufacturing facility of a Letermovir active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Letermovir APIs or Letermovir finished pharmaceutical products to another nation, regulatory agencies frequently require a Letermovir WC (written confirmation) as part of the regulatory process.
click here to find a list of Letermovir suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Letermovir as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Letermovir API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Letermovir as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Letermovir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Letermovir NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Letermovir suppliers with NDC on PharmaCompass.
Letermovir 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 Letermovir 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 Letermovir GMP manufacturer or Letermovir GMP API supplier for your needs.
A Letermovir CoA (Certificate of Analysis) is a formal document that attests to Letermovir's compliance with Letermovir specifications and serves as a tool for batch-level quality control.
Letermovir CoA mostly includes findings from lab analyses of a specific batch. For each Letermovir 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.
Letermovir may be tested according to a variety of international standards, such as European Pharmacopoeia (Letermovir EP), Letermovir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Letermovir USP).
