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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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
About the Company : Founded in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. The company supports customers in the development, scale-up, and man...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
With Virupaksha, you get a quality product with on-time delivery.
About the Company : Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylaram produce high-qual...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
About the Company : Supriya Lifescience Limited, established in 1987 and headquartered in Mumbai, is a globally recognized, technology-driven manufacturer of APIs, CDMO, and formulations. Its faciliti...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
Maithri Drugs: Dedicated to your API needs.
About the Company : Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, ant...
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,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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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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
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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 Ketalar manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ketalar, including repackagers and relabelers. The FDA regulates Ketalar manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ketalar 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 Ketalar manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ketalar supplier is an individual or a company that provides Ketalar active pharmaceutical ingredient (API) or Ketalar finished formulations upon request. The Ketalar suppliers may include Ketalar API manufacturers, exporters, distributors and traders.
click here to find a list of Ketalar suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ketalar DMF (Drug Master File) is a document detailing the whole manufacturing process of Ketalar active pharmaceutical ingredient (API) in detail. Different forms of Ketalar DMFs exist exist since differing nations have different regulations, such as Ketalar USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ketalar DMF submitted to regulatory agencies in the US is known as a USDMF. Ketalar USDMF includes data on Ketalar's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ketalar USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ketalar 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 Ketalar Drug Master File in Japan (Ketalar JDMF) empowers Ketalar 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 Ketalar JDMF during the approval evaluation for pharmaceutical products. At the time of Ketalar 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 Ketalar suppliers with JDMF on PharmaCompass.
A Ketalar CEP of the European Pharmacopoeia monograph is often referred to as a Ketalar Certificate of Suitability (COS). The purpose of a Ketalar CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ketalar EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ketalar to their clients by showing that a Ketalar CEP has been issued for it. The manufacturer submits a Ketalar CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ketalar CEP holder for the record. Additionally, the data presented in the Ketalar CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ketalar DMF.
A Ketalar CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ketalar 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 Ketalar suppliers with CEP (COS) on PharmaCompass.
A Ketalar written confirmation (Ketalar WC) is an official document issued by a regulatory agency to a Ketalar manufacturer, verifying that the manufacturing facility of a Ketalar active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ketalar APIs or Ketalar finished pharmaceutical products to another nation, regulatory agencies frequently require a Ketalar WC (written confirmation) as part of the regulatory process.
click here to find a list of Ketalar 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 Ketalar as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ketalar 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 Ketalar 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 Ketalar and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ketalar NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ketalar suppliers with NDC on PharmaCompass.
Ketalar 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 Ketalar 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 Ketalar GMP manufacturer or Ketalar GMP API supplier for your needs.
A Ketalar CoA (Certificate of Analysis) is a formal document that attests to Ketalar's compliance with Ketalar specifications and serves as a tool for batch-level quality control.
Ketalar CoA mostly includes findings from lab analyses of a specific batch. For each Ketalar 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.
Ketalar may be tested according to a variety of international standards, such as European Pharmacopoeia (Ketalar EP), Ketalar JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ketalar USP).
