Synopsis
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API Suppliers
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USDMF
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CEP/COS
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JDMF
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EU WC
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NDC API
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VMF
0
Listed Suppliers
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FDF
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Europe
0
Canada
0
Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS0
US Patents
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US Exclusivities
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Health Canada Patents
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
US Medicaid
NA
Annual Reports
NA
Finished Drug Prices
NA
DRUG PRODUCT COMPOSITIONS
DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 24.6...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 24.65MG
USFDA APPLICATION NUMBER - 202342
DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 49.3...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 49.3MG
USFDA APPLICATION NUMBER - 202342
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Esomeprazole Strontium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Esomeprazole Strontium, including repackagers and relabelers. The FDA regulates Esomeprazole Strontium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Esomeprazole Strontium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Esomeprazole Strontium supplier is an individual or a company that provides Esomeprazole Strontium active pharmaceutical ingredient (API) or Esomeprazole Strontium finished formulations upon request. The Esomeprazole Strontium suppliers may include Esomeprazole Strontium API manufacturers, exporters, distributors and traders.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Esomeprazole Strontium Drug Master File in Korea (Esomeprazole Strontium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Esomeprazole Strontium. The MFDS reviews the Esomeprazole Strontium KDMF as part of the drug registration process and uses the information provided in the Esomeprazole Strontium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Esomeprazole Strontium 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 Esomeprazole Strontium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Esomeprazole Strontium suppliers with KDMF on PharmaCompass.
Esomeprazole Strontium 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 Esomeprazole Strontium 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 Esomeprazole Strontium GMP manufacturer or Esomeprazole Strontium GMP API supplier for your needs.
A Esomeprazole Strontium CoA (Certificate of Analysis) is a formal document that attests to Esomeprazole Strontium's compliance with Esomeprazole Strontium specifications and serves as a tool for batch-level quality control.
Esomeprazole Strontium CoA mostly includes findings from lab analyses of a specific batch. For each Esomeprazole Strontium 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.
Esomeprazole Strontium may be tested according to a variety of international standards, such as European Pharmacopoeia (Esomeprazole Strontium EP), Esomeprazole Strontium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Esomeprazole Strontium USP).
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