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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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USDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2023-02-27
Pay. Date : 2021-04-15
DMF Number : 28405
Submission : 2014-07-11
Status :
Type : II
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Lomustine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lomustine, including repackagers and relabelers. The FDA regulates Lomustine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lomustine 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 Lomustine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lomustine supplier is an individual or a company that provides Lomustine active pharmaceutical ingredient (API) or Lomustine finished formulations upon request. The Lomustine suppliers may include Lomustine API manufacturers, exporters, distributors and traders.
click here to find a list of Lomustine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lomustine DMF (Drug Master File) is a document detailing the whole manufacturing process of Lomustine active pharmaceutical ingredient (API) in detail. Different forms of Lomustine DMFs exist exist since differing nations have different regulations, such as Lomustine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lomustine DMF submitted to regulatory agencies in the US is known as a USDMF. Lomustine USDMF includes data on Lomustine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lomustine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lomustine suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Lomustine Drug Master File in Japan (Lomustine JDMF) empowers Lomustine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Lomustine JDMF during the approval evaluation for pharmaceutical products. At the time of Lomustine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Lomustine suppliers with JDMF on PharmaCompass.
A Lomustine CEP of the European Pharmacopoeia monograph is often referred to as a Lomustine Certificate of Suitability (COS). The purpose of a Lomustine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lomustine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lomustine to their clients by showing that a Lomustine CEP has been issued for it. The manufacturer submits a Lomustine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lomustine CEP holder for the record. Additionally, the data presented in the Lomustine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lomustine DMF.
A Lomustine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lomustine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Lomustine suppliers with CEP (COS) on PharmaCompass.
A Lomustine written confirmation (Lomustine WC) is an official document issued by a regulatory agency to a Lomustine manufacturer, verifying that the manufacturing facility of a Lomustine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lomustine APIs or Lomustine finished pharmaceutical products to another nation, regulatory agencies frequently require a Lomustine WC (written confirmation) as part of the regulatory process.
click here to find a list of Lomustine 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 Lomustine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lomustine 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 Lomustine 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 Lomustine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lomustine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lomustine suppliers with NDC on PharmaCompass.
Lomustine 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 Lomustine 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 Lomustine GMP manufacturer or Lomustine GMP API supplier for your needs.
A Lomustine CoA (Certificate of Analysis) is a formal document that attests to Lomustine's compliance with Lomustine specifications and serves as a tool for batch-level quality control.
Lomustine CoA mostly includes findings from lab analyses of a specific batch. For each Lomustine 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.
Lomustine may be tested according to a variety of international standards, such as European Pharmacopoeia (Lomustine EP), Lomustine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lomustine USP).
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