API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
94
PharmaCompass offers a list of Dexlansoprazole 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 Dexlansoprazole manufacturer or Dexlansoprazole supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dexlansoprazole manufacturer or Dexlansoprazole supplier.
PharmaCompass also assists you with knowing the Dexlansoprazole API Price utilized in the formulation of products. Dexlansoprazole API Price is not always fixed or binding as the Dexlansoprazole Price is obtained through a variety of data sources. The Dexlansoprazole Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dexlansoprazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexlansoprazole, including repackagers and relabelers. The FDA regulates Dexlansoprazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexlansoprazole 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 Dexlansoprazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dexlansoprazole supplier is an individual or a company that provides Dexlansoprazole active pharmaceutical ingredient (API) or Dexlansoprazole finished formulations upon request. The Dexlansoprazole suppliers may include Dexlansoprazole API manufacturers, exporters, distributors and traders.
click here to find a list of Dexlansoprazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dexlansoprazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Dexlansoprazole active pharmaceutical ingredient (API) in detail. Different forms of Dexlansoprazole DMFs exist exist since differing nations have different regulations, such as Dexlansoprazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dexlansoprazole DMF submitted to regulatory agencies in the US is known as a USDMF. Dexlansoprazole USDMF includes data on Dexlansoprazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dexlansoprazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dexlansoprazole 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 Dexlansoprazole Drug Master File in Korea (Dexlansoprazole KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dexlansoprazole. The MFDS reviews the Dexlansoprazole KDMF as part of the drug registration process and uses the information provided in the Dexlansoprazole KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dexlansoprazole 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 Dexlansoprazole API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dexlansoprazole suppliers with KDMF on PharmaCompass.
A Dexlansoprazole written confirmation (Dexlansoprazole WC) is an official document issued by a regulatory agency to a Dexlansoprazole manufacturer, verifying that the manufacturing facility of a Dexlansoprazole active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dexlansoprazole APIs or Dexlansoprazole finished pharmaceutical products to another nation, regulatory agencies frequently require a Dexlansoprazole WC (written confirmation) as part of the regulatory process.
click here to find a list of Dexlansoprazole 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 Dexlansoprazole as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dexlansoprazole 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 Dexlansoprazole 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 Dexlansoprazole and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dexlansoprazole NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dexlansoprazole suppliers with NDC on PharmaCompass.
Dexlansoprazole 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 Dexlansoprazole 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 Dexlansoprazole GMP manufacturer or Dexlansoprazole GMP API supplier for your needs.
A Dexlansoprazole CoA (Certificate of Analysis) is a formal document that attests to Dexlansoprazole's compliance with Dexlansoprazole specifications and serves as a tool for batch-level quality control.
Dexlansoprazole CoA mostly includes findings from lab analyses of a specific batch. For each Dexlansoprazole 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.
Dexlansoprazole may be tested according to a variety of international standards, such as European Pharmacopoeia (Dexlansoprazole EP), Dexlansoprazole JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dexlansoprazole USP).