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Drugs in Development
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DOSAGE - CAPSULE;ORAL - 24MCG
USFDA APPLICATION NUMBER - 21908
DOSAGE - CAPSULE;ORAL - 8MCG
USFDA APPLICATION NUMBER - 21908
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ABOUT THIS PAGE
A Lubiprostone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lubiprostone, including repackagers and relabelers. The FDA regulates Lubiprostone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lubiprostone 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 Lubiprostone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lubiprostone supplier is an individual or a company that provides Lubiprostone active pharmaceutical ingredient (API) or Lubiprostone finished formulations upon request. The Lubiprostone suppliers may include Lubiprostone API manufacturers, exporters, distributors and traders.
click here to find a list of Lubiprostone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lubiprostone DMF (Drug Master File) is a document detailing the whole manufacturing process of Lubiprostone active pharmaceutical ingredient (API) in detail. Different forms of Lubiprostone DMFs exist exist since differing nations have different regulations, such as Lubiprostone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lubiprostone DMF submitted to regulatory agencies in the US is known as a USDMF. Lubiprostone USDMF includes data on Lubiprostone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lubiprostone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lubiprostone 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 Lubiprostone Drug Master File in Japan (Lubiprostone JDMF) empowers Lubiprostone 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 Lubiprostone JDMF during the approval evaluation for pharmaceutical products. At the time of Lubiprostone 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 Lubiprostone suppliers with JDMF on PharmaCompass.
A Lubiprostone written confirmation (Lubiprostone WC) is an official document issued by a regulatory agency to a Lubiprostone manufacturer, verifying that the manufacturing facility of a Lubiprostone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lubiprostone APIs or Lubiprostone finished pharmaceutical products to another nation, regulatory agencies frequently require a Lubiprostone WC (written confirmation) as part of the regulatory process.
click here to find a list of Lubiprostone 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 Lubiprostone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lubiprostone 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 Lubiprostone 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 Lubiprostone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lubiprostone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lubiprostone suppliers with NDC on PharmaCompass.
Lubiprostone 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 Lubiprostone 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 Lubiprostone GMP manufacturer or Lubiprostone GMP API supplier for your needs.
A Lubiprostone CoA (Certificate of Analysis) is a formal document that attests to Lubiprostone's compliance with Lubiprostone specifications and serves as a tool for batch-level quality control.
Lubiprostone CoA mostly includes findings from lab analyses of a specific batch. For each Lubiprostone 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.
Lubiprostone may be tested according to a variety of international standards, such as European Pharmacopoeia (Lubiprostone EP), Lubiprostone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lubiprostone USP).
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