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API SUPPLIERS
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
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NDC
ASMF, BR...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
CEP/COS
EU-WC
NDC
ASMF
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
ASMF
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USDMF
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16737
Submission : 2003-07-31
Status :
Type : II
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36426
Submission : 2021-11-08
Status :
Type : II
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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
Certificate Number : CEP 2017-216 - Rev 02
Status : Valid
Issue Date : 2023-11-08
Type : Chemical
Substance Number : 1742
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Certificate Number : CEP 2018-198 - Rev 01
Status : Valid
Issue Date : 2025-01-31
Type : Chemical
Substance Number : 1742
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Esketamine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Supriya Lifescience Expands Global Footprint with Esketamine Hydrochloride Approval
Details : Esketamine HCl is a non-selective, non-competitive NMDA receptor antagonist, approved for treating mental illness.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
December 09, 2024
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08 Jan 2019
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ABOUT THIS PAGE
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PharmaCompass offers a list of Esketamine Hydrochloride 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 Esketamine Hydrochloride manufacturer or Esketamine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Esketamine Hydrochloride manufacturer or Esketamine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Esketamine Hydrochloride API Price utilized in the formulation of products. Esketamine Hydrochloride API Price is not always fixed or binding as the Esketamine Hydrochloride Price is obtained through a variety of data sources. The Esketamine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A esketamine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of esketamine HCl, including repackagers and relabelers. The FDA regulates esketamine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. esketamine HCl 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 esketamine HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A esketamine HCl supplier is an individual or a company that provides esketamine HCl active pharmaceutical ingredient (API) or esketamine HCl finished formulations upon request. The esketamine HCl suppliers may include esketamine HCl API manufacturers, exporters, distributors and traders.
click here to find a list of esketamine HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A esketamine HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of esketamine HCl active pharmaceutical ingredient (API) in detail. Different forms of esketamine HCl DMFs exist exist since differing nations have different regulations, such as esketamine HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A esketamine HCl DMF submitted to regulatory agencies in the US is known as a USDMF. esketamine HCl USDMF includes data on esketamine HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The esketamine HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of esketamine HCl suppliers with USDMF on PharmaCompass.
A esketamine HCl CEP of the European Pharmacopoeia monograph is often referred to as a esketamine HCl Certificate of Suitability (COS). The purpose of a esketamine HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of esketamine HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of esketamine HCl to their clients by showing that a esketamine HCl CEP has been issued for it. The manufacturer submits a esketamine HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a esketamine HCl CEP holder for the record. Additionally, the data presented in the esketamine HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the esketamine HCl DMF.
A esketamine HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. esketamine HCl 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 esketamine HCl suppliers with CEP (COS) on PharmaCompass.
A esketamine HCl written confirmation (esketamine HCl WC) is an official document issued by a regulatory agency to a esketamine HCl manufacturer, verifying that the manufacturing facility of a esketamine HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting esketamine HCl APIs or esketamine HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a esketamine HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of esketamine HCl 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 esketamine HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for esketamine HCl 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 esketamine HCl 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 esketamine HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a esketamine HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of esketamine HCl suppliers with NDC on PharmaCompass.
esketamine HCl 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 esketamine HCl 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 esketamine HCl GMP manufacturer or esketamine HCl GMP API supplier for your needs.
A esketamine HCl CoA (Certificate of Analysis) is a formal document that attests to esketamine HCl's compliance with esketamine HCl specifications and serves as a tool for batch-level quality control.
esketamine HCl CoA mostly includes findings from lab analyses of a specific batch. For each esketamine HCl 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.
esketamine HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (esketamine HCl EP), esketamine HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (esketamine HCl USP).
Comment (8)
