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JDMF
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Australia
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API SUPPLIERS
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USDMF
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DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 30MG
USFDA APPLICATION NUMBER - 22287
DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 60MG
USFDA APPLICATION NUMBER - 22287
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ABOUT THIS PAGE
26
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 DEXILANT SOLUTAB manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DEXILANT SOLUTAB, including repackagers and relabelers. The FDA regulates DEXILANT SOLUTAB manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DEXILANT SOLUTAB 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 DEXILANT SOLUTAB manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A DEXILANT SOLUTAB supplier is an individual or a company that provides DEXILANT SOLUTAB active pharmaceutical ingredient (API) or DEXILANT SOLUTAB finished formulations upon request. The DEXILANT SOLUTAB suppliers may include DEXILANT SOLUTAB API manufacturers, exporters, distributors and traders.
click here to find a list of DEXILANT SOLUTAB suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DEXILANT SOLUTAB DMF (Drug Master File) is a document detailing the whole manufacturing process of DEXILANT SOLUTAB active pharmaceutical ingredient (API) in detail. Different forms of DEXILANT SOLUTAB DMFs exist exist since differing nations have different regulations, such as DEXILANT SOLUTAB USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DEXILANT SOLUTAB DMF submitted to regulatory agencies in the US is known as a USDMF. DEXILANT SOLUTAB USDMF includes data on DEXILANT SOLUTAB's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DEXILANT SOLUTAB USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DEXILANT SOLUTAB 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 DEXILANT SOLUTAB Drug Master File in Korea (DEXILANT SOLUTAB KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of DEXILANT SOLUTAB. The MFDS reviews the DEXILANT SOLUTAB KDMF as part of the drug registration process and uses the information provided in the DEXILANT SOLUTAB KDMF to evaluate the safety and efficacy of the drug.
After submitting a DEXILANT SOLUTAB 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 DEXILANT SOLUTAB API can apply through the Korea Drug Master File (KDMF).
click here to find a list of DEXILANT SOLUTAB suppliers with KDMF on PharmaCompass.
A DEXILANT SOLUTAB written confirmation (DEXILANT SOLUTAB WC) is an official document issued by a regulatory agency to a DEXILANT SOLUTAB manufacturer, verifying that the manufacturing facility of a DEXILANT SOLUTAB active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting DEXILANT SOLUTAB APIs or DEXILANT SOLUTAB finished pharmaceutical products to another nation, regulatory agencies frequently require a DEXILANT SOLUTAB WC (written confirmation) as part of the regulatory process.
click here to find a list of DEXILANT SOLUTAB 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 DEXILANT SOLUTAB as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for DEXILANT SOLUTAB 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 DEXILANT SOLUTAB 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 DEXILANT SOLUTAB and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DEXILANT SOLUTAB NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of DEXILANT SOLUTAB suppliers with NDC on PharmaCompass.
DEXILANT SOLUTAB 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 DEXILANT SOLUTAB 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 DEXILANT SOLUTAB GMP manufacturer or DEXILANT SOLUTAB GMP API supplier for your needs.
A DEXILANT SOLUTAB CoA (Certificate of Analysis) is a formal document that attests to DEXILANT SOLUTAB's compliance with DEXILANT SOLUTAB specifications and serves as a tool for batch-level quality control.
DEXILANT SOLUTAB CoA mostly includes findings from lab analyses of a specific batch. For each DEXILANT SOLUTAB 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.
DEXILANT SOLUTAB may be tested according to a variety of international standards, such as European Pharmacopoeia (DEXILANT SOLUTAB EP), DEXILANT SOLUTAB JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DEXILANT SOLUTAB USP).
