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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, Price,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.
PharmaCompass also assists you with knowing the Escitalopram Oxalate API Price utilized in the formulation of products. Escitalopram Oxalate API Price is not always fixed or binding as the Escitalopram Oxalate Price is obtained through a variety of data sources. The Escitalopram Oxalate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Escitalopram Oxalate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Escitalopram Oxalate, including repackagers and relabelers. The FDA regulates Escitalopram Oxalate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Escitalopram Oxalate 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 Oxalate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Escitalopram Oxalate supplier is an individual or a company that provides Escitalopram Oxalate active pharmaceutical ingredient (API) or Escitalopram Oxalate finished formulations upon request. The Escitalopram Oxalate suppliers may include Escitalopram Oxalate API manufacturers, exporters, distributors and traders.
click here to find a list of Escitalopram Oxalate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Escitalopram Oxalate DMF (Drug Master File) is a document detailing the whole manufacturing process of Escitalopram Oxalate active pharmaceutical ingredient (API) in detail. Different forms of Escitalopram Oxalate DMFs exist exist since differing nations have different regulations, such as Escitalopram Oxalate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Escitalopram Oxalate DMF submitted to regulatory agencies in the US is known as a USDMF. Escitalopram Oxalate USDMF includes data on Escitalopram Oxalate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Escitalopram Oxalate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Escitalopram Oxalate 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 Oxalate Drug Master File in Japan (Escitalopram Oxalate JDMF) empowers Escitalopram Oxalate 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 Oxalate JDMF during the approval evaluation for pharmaceutical products. At the time of Escitalopram Oxalate 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 Oxalate 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 Oxalate Drug Master File in Korea (Escitalopram Oxalate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Escitalopram Oxalate. The MFDS reviews the Escitalopram Oxalate KDMF as part of the drug registration process and uses the information provided in the Escitalopram Oxalate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Escitalopram Oxalate 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 Oxalate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Escitalopram Oxalate suppliers with KDMF on PharmaCompass.
A Escitalopram Oxalate CEP of the European Pharmacopoeia monograph is often referred to as a Escitalopram Oxalate Certificate of Suitability (COS). The purpose of a Escitalopram Oxalate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Escitalopram Oxalate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Escitalopram Oxalate to their clients by showing that a Escitalopram Oxalate CEP has been issued for it. The manufacturer submits a Escitalopram Oxalate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Escitalopram Oxalate CEP holder for the record. Additionally, the data presented in the Escitalopram Oxalate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Escitalopram Oxalate DMF.
A Escitalopram Oxalate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Escitalopram Oxalate 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 Oxalate suppliers with CEP (COS) on PharmaCompass.
A Escitalopram Oxalate written confirmation (Escitalopram Oxalate WC) is an official document issued by a regulatory agency to a Escitalopram Oxalate manufacturer, verifying that the manufacturing facility of a Escitalopram Oxalate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Escitalopram Oxalate APIs or Escitalopram Oxalate finished pharmaceutical products to another nation, regulatory agencies frequently require a Escitalopram Oxalate WC (written confirmation) as part of the regulatory process.
click here to find a list of Escitalopram Oxalate 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 Oxalate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Escitalopram Oxalate 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 Oxalate 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 Oxalate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Escitalopram Oxalate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Escitalopram Oxalate suppliers with NDC on PharmaCompass.
Escitalopram Oxalate 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 Oxalate 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 Escitalopram Oxalate GMP manufacturer or Escitalopram Oxalate GMP API supplier for your needs.
A Escitalopram Oxalate CoA (Certificate of Analysis) is a formal document that attests to Escitalopram Oxalate's compliance with Escitalopram Oxalate specifications and serves as a tool for batch-level quality control.
Escitalopram Oxalate CoA mostly includes findings from lab analyses of a specific batch. For each Escitalopram Oxalate 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 Oxalate may be tested according to a variety of international standards, such as European Pharmacopoeia (Escitalopram Oxalate EP), Escitalopram Oxalate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Escitalopram Oxalate USP).
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