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PharmaCompass offers a list of Lansoprazole 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 Lansoprazole manufacturer or Lansoprazole supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lansoprazole manufacturer or Lansoprazole supplier.
PharmaCompass also assists you with knowing the Lansoprazole API Price utilized in the formulation of products. Lansoprazole API Price is not always fixed or binding as the Lansoprazole Price is obtained through a variety of data sources. The Lansoprazole Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A PREVACID 24 HR manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PREVACID 24 HR, including repackagers and relabelers. The FDA regulates PREVACID 24 HR manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PREVACID 24 HR 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 PREVACID 24 HR manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A PREVACID 24 HR supplier is an individual or a company that provides PREVACID 24 HR active pharmaceutical ingredient (API) or PREVACID 24 HR finished formulations upon request. The PREVACID 24 HR suppliers may include PREVACID 24 HR API manufacturers, exporters, distributors and traders.
click here to find a list of PREVACID 24 HR suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A PREVACID 24 HR DMF (Drug Master File) is a document detailing the whole manufacturing process of PREVACID 24 HR active pharmaceutical ingredient (API) in detail. Different forms of PREVACID 24 HR DMFs exist exist since differing nations have different regulations, such as PREVACID 24 HR USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PREVACID 24 HR DMF submitted to regulatory agencies in the US is known as a USDMF. PREVACID 24 HR USDMF includes data on PREVACID 24 HR's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PREVACID 24 HR USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of PREVACID 24 HR 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 PREVACID 24 HR Drug Master File in Japan (PREVACID 24 HR JDMF) empowers PREVACID 24 HR 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 PREVACID 24 HR JDMF during the approval evaluation for pharmaceutical products. At the time of PREVACID 24 HR 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 PREVACID 24 HR 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 PREVACID 24 HR Drug Master File in Korea (PREVACID 24 HR KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of PREVACID 24 HR. The MFDS reviews the PREVACID 24 HR KDMF as part of the drug registration process and uses the information provided in the PREVACID 24 HR KDMF to evaluate the safety and efficacy of the drug.
After submitting a PREVACID 24 HR 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 PREVACID 24 HR API can apply through the Korea Drug Master File (KDMF).
click here to find a list of PREVACID 24 HR suppliers with KDMF on PharmaCompass.
A PREVACID 24 HR CEP of the European Pharmacopoeia monograph is often referred to as a PREVACID 24 HR Certificate of Suitability (COS). The purpose of a PREVACID 24 HR CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of PREVACID 24 HR EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of PREVACID 24 HR to their clients by showing that a PREVACID 24 HR CEP has been issued for it. The manufacturer submits a PREVACID 24 HR CEP (COS) as part of the market authorization procedure, and it takes on the role of a PREVACID 24 HR CEP holder for the record. Additionally, the data presented in the PREVACID 24 HR CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the PREVACID 24 HR DMF.
A PREVACID 24 HR CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. PREVACID 24 HR 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 PREVACID 24 HR suppliers with CEP (COS) on PharmaCompass.
A PREVACID 24 HR written confirmation (PREVACID 24 HR WC) is an official document issued by a regulatory agency to a PREVACID 24 HR manufacturer, verifying that the manufacturing facility of a PREVACID 24 HR active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting PREVACID 24 HR APIs or PREVACID 24 HR finished pharmaceutical products to another nation, regulatory agencies frequently require a PREVACID 24 HR WC (written confirmation) as part of the regulatory process.
click here to find a list of PREVACID 24 HR 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 PREVACID 24 HR as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for PREVACID 24 HR 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 PREVACID 24 HR 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 PREVACID 24 HR and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a PREVACID 24 HR NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of PREVACID 24 HR suppliers with NDC on PharmaCompass.
PREVACID 24 HR 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 PREVACID 24 HR 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 PREVACID 24 HR GMP manufacturer or PREVACID 24 HR GMP API supplier for your needs.
A PREVACID 24 HR CoA (Certificate of Analysis) is a formal document that attests to PREVACID 24 HR's compliance with PREVACID 24 HR specifications and serves as a tool for batch-level quality control.
PREVACID 24 HR CoA mostly includes findings from lab analyses of a specific batch. For each PREVACID 24 HR 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.
PREVACID 24 HR may be tested according to a variety of international standards, such as European Pharmacopoeia (PREVACID 24 HR EP), PREVACID 24 HR JP (Japanese Pharmacopeia) and the US Pharmacopoeia (PREVACID 24 HR USP).
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