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CEP/COS
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JDMF
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VMF
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Australia
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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API SUPPLIERS
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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USDMF
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38997
Submission : 2023-12-04
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34971
Submission : 2020-09-29
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43411
Submission : 2025-12-30
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39595
Submission : 2024-04-23
Status :
Type : II
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Date of Issue : 2024-04-03
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm : Unit-IV, Plot No: 34B, 40B & 60B, J.N. Pharma City, Thanam (V), Parawada (M), An...
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
2-Chloromethyl-3-methyl-4-(2,2,2-trifluoroethoxy)p...
CAS Number : 127337-60-4
End Use API : Dexlansoprazole
About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
2-[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridylmet...
CAS Number : 103577-40-8
End Use API : Dexlansoprazole
About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
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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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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
76
PharmaCompass offers a list of Dexlansoprazole API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.
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, and COA 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, and COA 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, 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).
