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DOSAGE - TABLET;ORAL - EQ 10MG BASE
USFDA APPLICATION NUMBER - 21323
DOSAGE - TABLET;ORAL - EQ 20MG BASE
USFDA APPLICATION NUMBER - 21323
DOSAGE - TABLET;ORAL - EQ 5MG BASE
USFDA APPLICATION NUMBER - 21323
DOSAGE - SOLUTION;ORAL - EQ 5MG BASE/5ML **Fe...DOSAGE - SOLUTION;ORAL - EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21365
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Escitalopram Oxalate 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 Escitalopram Oxalate manufacturer or Escitalopram Oxalate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Escitalopram Oxalate manufacturer or Escitalopram Oxalate supplier.
A Escitalopram manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Escitalopram, including repackagers and relabelers. The FDA regulates Escitalopram manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Escitalopram 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 Escitalopram manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Escitalopram supplier is an individual or a company that provides Escitalopram active pharmaceutical ingredient (API) or Escitalopram finished formulations upon request. The Escitalopram suppliers may include Escitalopram API manufacturers, exporters, distributors and traders.
click here to find a list of Escitalopram suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Escitalopram DMF (Drug Master File) is a document detailing the whole manufacturing process of Escitalopram active pharmaceutical ingredient (API) in detail. Different forms of Escitalopram DMFs exist exist since differing nations have different regulations, such as Escitalopram USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Escitalopram DMF submitted to regulatory agencies in the US is known as a USDMF. Escitalopram USDMF includes data on Escitalopram's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Escitalopram USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Escitalopram 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 Escitalopram Drug Master File in Japan (Escitalopram JDMF) empowers Escitalopram 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 Escitalopram JDMF during the approval evaluation for pharmaceutical products. At the time of Escitalopram 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 Escitalopram 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 Escitalopram Drug Master File in Korea (Escitalopram KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Escitalopram. The MFDS reviews the Escitalopram KDMF as part of the drug registration process and uses the information provided in the Escitalopram KDMF to evaluate the safety and efficacy of the drug.
After submitting a Escitalopram 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 Escitalopram API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Escitalopram suppliers with KDMF on PharmaCompass.
A Escitalopram CEP of the European Pharmacopoeia monograph is often referred to as a Escitalopram Certificate of Suitability (COS). The purpose of a Escitalopram CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Escitalopram EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Escitalopram to their clients by showing that a Escitalopram CEP has been issued for it. The manufacturer submits a Escitalopram CEP (COS) as part of the market authorization procedure, and it takes on the role of a Escitalopram CEP holder for the record. Additionally, the data presented in the Escitalopram CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Escitalopram DMF.
A Escitalopram CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Escitalopram 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 Escitalopram suppliers with CEP (COS) on PharmaCompass.
A Escitalopram written confirmation (Escitalopram WC) is an official document issued by a regulatory agency to a Escitalopram manufacturer, verifying that the manufacturing facility of a Escitalopram active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Escitalopram APIs or Escitalopram finished pharmaceutical products to another nation, regulatory agencies frequently require a Escitalopram WC (written confirmation) as part of the regulatory process.
click here to find a list of Escitalopram 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 Escitalopram as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Escitalopram 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 Escitalopram 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 Escitalopram and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Escitalopram NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Escitalopram suppliers with NDC on PharmaCompass.
Escitalopram 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 Escitalopram GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Escitalopram GMP manufacturer or Escitalopram GMP API supplier for your needs.
A Escitalopram CoA (Certificate of Analysis) is a formal document that attests to Escitalopram's compliance with Escitalopram specifications and serves as a tool for batch-level quality control.
Escitalopram CoA mostly includes findings from lab analyses of a specific batch. For each Escitalopram 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.
Escitalopram may be tested according to a variety of international standards, such as European Pharmacopoeia (Escitalopram EP), Escitalopram JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Escitalopram USP).
