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PharmaCompass offers a list of Lubiprostone 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 Lubiprostone manufacturer or Lubiprostone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lubiprostone manufacturer or Lubiprostone supplier.
PharmaCompass also assists you with knowing the Lubiprostone API Price utilized in the formulation of products. Lubiprostone API Price is not always fixed or binding as the Lubiprostone Price is obtained through a variety of data sources. The Lubiprostone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Amitiza manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amitiza, including repackagers and relabelers. The FDA regulates Amitiza manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amitiza 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 Amitiza manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amitiza supplier is an individual or a company that provides Amitiza active pharmaceutical ingredient (API) or Amitiza finished formulations upon request. The Amitiza suppliers may include Amitiza API manufacturers, exporters, distributors and traders.
click here to find a list of Amitiza suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amitiza DMF (Drug Master File) is a document detailing the whole manufacturing process of Amitiza active pharmaceutical ingredient (API) in detail. Different forms of Amitiza DMFs exist exist since differing nations have different regulations, such as Amitiza USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amitiza DMF submitted to regulatory agencies in the US is known as a USDMF. Amitiza USDMF includes data on Amitiza's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amitiza USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amitiza 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 Amitiza Drug Master File in Japan (Amitiza JDMF) empowers Amitiza 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 Amitiza JDMF during the approval evaluation for pharmaceutical products. At the time of Amitiza 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 Amitiza suppliers with JDMF 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 Amitiza Drug Master File in Korea (Amitiza KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Amitiza. The MFDS reviews the Amitiza KDMF as part of the drug registration process and uses the information provided in the Amitiza KDMF to evaluate the safety and efficacy of the drug.
After submitting a Amitiza 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 Amitiza API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Amitiza suppliers with KDMF on PharmaCompass.
A Amitiza written confirmation (Amitiza WC) is an official document issued by a regulatory agency to a Amitiza manufacturer, verifying that the manufacturing facility of a Amitiza active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Amitiza APIs or Amitiza finished pharmaceutical products to another nation, regulatory agencies frequently require a Amitiza WC (written confirmation) as part of the regulatory process.
click here to find a list of Amitiza 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 Amitiza as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Amitiza 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 Amitiza 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 Amitiza and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Amitiza NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Amitiza suppliers with NDC on PharmaCompass.
Amitiza 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 Amitiza 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 Amitiza GMP manufacturer or Amitiza GMP API supplier for your needs.
A Amitiza CoA (Certificate of Analysis) is a formal document that attests to Amitiza's compliance with Amitiza specifications and serves as a tool for batch-level quality control.
Amitiza CoA mostly includes findings from lab analyses of a specific batch. For each Amitiza 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.
Amitiza may be tested according to a variety of international standards, such as European Pharmacopoeia (Amitiza EP), Amitiza JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Amitiza USP).