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API SUPPLIERS
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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 : Complete
Rev. Date : 2019-11-05
Pay. Date : 2019-10-28
DMF Number : 7686
Submission : 1988-09-22
Status :
Type : II
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : Complete
Rev. Date : 2022-12-22
Pay. Date : 2022-12-20
DMF Number : 27921
Submission : 2014-01-15
Status :
Type : II
Maithri Drugs: Dedicated to your API needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37014
Submission : 2022-03-29
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 2005-281 - Rev 02
Status : Valid
Issue Date : 2024-03-11
Type : Chemical
Substance Number : 1020
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Certificate Number : CEP 2016-194 - Rev 01
Status : Valid
Issue Date : 2024-05-07
Type : Chemical
Substance Number : 1020
Maithri Drugs: Dedicated to your API needs.
Certificate Number : CEP 2022-157 - Rev 00
Status : Valid
Issue Date : 2024-03-04
Type : Chemical
Substance Number : 1020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
Registration Number : 218MF10980
Registrant's Address : Raiffeisenstrasse 4, D-77933 Lahr Germany
Initial Date of Registration : 2006-12-01
Latest Date of Registration : 2021-12-09
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
Lead Product(s) : Ketamine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Assessment of Abuse Potential of Rapastinel in Humans
Details : Ketamine is a Controlled Substance drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Substance-Related Disorders.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
January 10, 2019
Lead Product(s) : Ketamine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
R-107 Depression Study Results Published in Nature Medicine
Details : R-107 (ketamine) is an oral NMDA receptor negative allosteric modulator, small molecule drug candidate, which is being evaluated for the treatment of treatment-resistant depression.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
June 25, 2024
Lead Product(s) : Ketamine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Douglas Pharmaceuticals Announces Formation of Clinical Advisory Board for Lead Program R-107
Details : R-107, an oral extended-release dose of racemic ketamine being developed as add-on or monotherapy for treatment resistant depression (TRD). It has demonstrated a significant antidepressant effect with maintenance of response at 3 months, high compliance ...
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
January 26, 2023
Lead Product(s) : Ketamine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Trial Data Suggests Major Breakthrough in Treatment Resistant Depression
Details : R-107 (extended-release oral dose of ketamine) act as a blocks the NMDA receptor and it is investigated for the treatment of treatment resistant depression.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
June 15, 2021
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DOSAGE - INJECTABLE;INJECTION - EQ 100MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 100MG BASE/ML
USFDA APPLICATION NUMBER - 16812
DOSAGE - INJECTABLE;INJECTION - EQ 10MG BASE/...DOSAGE - INJECTABLE;INJECTION - EQ 10MG BASE/ML
USFDA APPLICATION NUMBER - 16812
DOSAGE - INJECTABLE;INJECTION - EQ 50MG BASE/...DOSAGE - INJECTABLE;INJECTION - EQ 50MG BASE/ML
USFDA APPLICATION NUMBER - 16812
Related Excipient Companies
Nanjing Well Pharmaceutical
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ABOUT THIS PAGE
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PharmaCompass offers a list of Ketamine 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 Ketamine Hydrochloride manufacturer or Ketamine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ketamine Hydrochloride manufacturer or Ketamine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Ketamine Hydrochloride API Price utilized in the formulation of products. Ketamine Hydrochloride API Price is not always fixed or binding as the Ketamine Hydrochloride Price is obtained through a variety of data sources. The Ketamine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ketanest manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ketanest, including repackagers and relabelers. The FDA regulates Ketanest manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ketanest 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 Ketanest manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ketanest supplier is an individual or a company that provides Ketanest active pharmaceutical ingredient (API) or Ketanest finished formulations upon request. The Ketanest suppliers may include Ketanest API manufacturers, exporters, distributors and traders.
click here to find a list of Ketanest suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ketanest DMF (Drug Master File) is a document detailing the whole manufacturing process of Ketanest active pharmaceutical ingredient (API) in detail. Different forms of Ketanest DMFs exist exist since differing nations have different regulations, such as Ketanest USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ketanest DMF submitted to regulatory agencies in the US is known as a USDMF. Ketanest USDMF includes data on Ketanest's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ketanest USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ketanest 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 Ketanest Drug Master File in Japan (Ketanest JDMF) empowers Ketanest 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 Ketanest JDMF during the approval evaluation for pharmaceutical products. At the time of Ketanest 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 Ketanest suppliers with JDMF on PharmaCompass.
A Ketanest CEP of the European Pharmacopoeia monograph is often referred to as a Ketanest Certificate of Suitability (COS). The purpose of a Ketanest CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ketanest EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ketanest to their clients by showing that a Ketanest CEP has been issued for it. The manufacturer submits a Ketanest CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ketanest CEP holder for the record. Additionally, the data presented in the Ketanest CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ketanest DMF.
A Ketanest CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ketanest 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 Ketanest suppliers with CEP (COS) on PharmaCompass.
A Ketanest written confirmation (Ketanest WC) is an official document issued by a regulatory agency to a Ketanest manufacturer, verifying that the manufacturing facility of a Ketanest active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ketanest APIs or Ketanest finished pharmaceutical products to another nation, regulatory agencies frequently require a Ketanest WC (written confirmation) as part of the regulatory process.
click here to find a list of Ketanest 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 Ketanest as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ketanest 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 Ketanest 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 Ketanest and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ketanest NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ketanest suppliers with NDC on PharmaCompass.
Ketanest 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 Ketanest 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 Ketanest GMP manufacturer or Ketanest GMP API supplier for your needs.
A Ketanest CoA (Certificate of Analysis) is a formal document that attests to Ketanest's compliance with Ketanest specifications and serves as a tool for batch-level quality control.
Ketanest CoA mostly includes findings from lab analyses of a specific batch. For each Ketanest 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.
Ketanest may be tested according to a variety of international standards, such as European Pharmacopoeia (Ketanest EP), Ketanest JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ketanest USP).
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