Synopsis
0
KDMF
0
Australia
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Ketamine Hydrochloride BP/EP/USP
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0218n
Address of the Firm : A-5/2, Late Parshuram Industrial Area, MIDC, Tal-Khed, Dist. Ratnagiri-415 722, ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
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
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
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 : R-107
Product Type : Controlled Substance
Upfront Cash : Inapplicable
June 25, 2024
Lead Product(s) : Ketamine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
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 : R-107
Product Type : Controlled Substance
Upfront Cash : Inapplicable
January 26, 2023
Lead Product(s) : Ketamine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
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 : R-107
Product Type : Controlled Substance
Upfront Cash : Inapplicable
June 15, 2021
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Parenteral
Solubilizers
Topical
Emulsifying Agents
Film Formers & Plasticizers
Controlled & Modified Release
Thickeners and Stabilizers
Coating Systems & Additives
Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
86
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 Ketamine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ketamine HCl, including repackagers and relabelers. The FDA regulates Ketamine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ketamine 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 Ketamine HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ketamine HCl supplier is an individual or a company that provides Ketamine HCl active pharmaceutical ingredient (API) or Ketamine HCl finished formulations upon request. The Ketamine HCl suppliers may include Ketamine HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Ketamine HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ketamine HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Ketamine HCl active pharmaceutical ingredient (API) in detail. Different forms of Ketamine HCl DMFs exist exist since differing nations have different regulations, such as Ketamine HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ketamine HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Ketamine HCl USDMF includes data on Ketamine HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ketamine HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ketamine HCl 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 Ketamine HCl Drug Master File in Japan (Ketamine HCl JDMF) empowers Ketamine HCl 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 Ketamine HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Ketamine HCl 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 Ketamine HCl suppliers with JDMF on PharmaCompass.
A Ketamine HCl CEP of the European Pharmacopoeia monograph is often referred to as a Ketamine HCl Certificate of Suitability (COS). The purpose of a Ketamine HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ketamine HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ketamine HCl to their clients by showing that a Ketamine HCl CEP has been issued for it. The manufacturer submits a Ketamine HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ketamine HCl CEP holder for the record. Additionally, the data presented in the Ketamine HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ketamine HCl DMF.
A Ketamine HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ketamine 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 Ketamine HCl suppliers with CEP (COS) on PharmaCompass.
A Ketamine HCl written confirmation (Ketamine HCl WC) is an official document issued by a regulatory agency to a Ketamine HCl manufacturer, verifying that the manufacturing facility of a Ketamine HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ketamine HCl APIs or Ketamine HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Ketamine HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Ketamine 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 Ketamine HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ketamine 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 Ketamine 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 Ketamine HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ketamine HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ketamine HCl suppliers with NDC on PharmaCompass.
Ketamine 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 Ketamine 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 Ketamine HCl GMP manufacturer or Ketamine HCl GMP API supplier for your needs.
A Ketamine HCl CoA (Certificate of Analysis) is a formal document that attests to Ketamine HCl's compliance with Ketamine HCl specifications and serves as a tool for batch-level quality control.
Ketamine HCl CoA mostly includes findings from lab analyses of a specific batch. For each Ketamine 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.
Ketamine HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Ketamine HCl EP), Ketamine HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ketamine HCl USP).
