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KDMF
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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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JDMF
NDC
ASMF, CA
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
CEP/COS
EU-WC
NDC
CA, ASMF...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
ASMF, CA
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
ASMF, CA
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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
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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
About the Company : Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists ...
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 the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
About the Company : Supriya Lifescience Ltd. specializes in API manufacturing, focusing on therapeutic segments like antihistamines, anti-allergic drugs, vitamins, anaesthetics and anti-asthmatics. Su...
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...
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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
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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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Topical
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgels
Grade : Parenteral, Oral, Topical
Application : Film Formers & Plasticizers, Parenteral, Thickeners and Stabilizers, Topical
Excipient Details : Propylene glycol is used as a solvent & stabilizer in injections. It is also used in topical semi-solids & as a plasticizer in soft capsules.
Emulsifying Agents
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Controlled & Modified Release
Thickeners and Stabilizers
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NEWS #PharmaBuzz
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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 C13H16ClNO.HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of C13H16ClNO.HCl, including repackagers and relabelers. The FDA regulates C13H16ClNO.HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. C13H16ClNO.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 C13H16ClNO.HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A C13H16ClNO.HCl supplier is an individual or a company that provides C13H16ClNO.HCl active pharmaceutical ingredient (API) or C13H16ClNO.HCl finished formulations upon request. The C13H16ClNO.HCl suppliers may include C13H16ClNO.HCl API manufacturers, exporters, distributors and traders.
click here to find a list of C13H16ClNO.HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A C13H16ClNO.HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of C13H16ClNO.HCl active pharmaceutical ingredient (API) in detail. Different forms of C13H16ClNO.HCl DMFs exist exist since differing nations have different regulations, such as C13H16ClNO.HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A C13H16ClNO.HCl DMF submitted to regulatory agencies in the US is known as a USDMF. C13H16ClNO.HCl USDMF includes data on C13H16ClNO.HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The C13H16ClNO.HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of C13H16ClNO.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 C13H16ClNO.HCl Drug Master File in Japan (C13H16ClNO.HCl JDMF) empowers C13H16ClNO.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 C13H16ClNO.HCl JDMF during the approval evaluation for pharmaceutical products. At the time of C13H16ClNO.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 C13H16ClNO.HCl suppliers with JDMF on PharmaCompass.
A C13H16ClNO.HCl CEP of the European Pharmacopoeia monograph is often referred to as a C13H16ClNO.HCl Certificate of Suitability (COS). The purpose of a C13H16ClNO.HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of C13H16ClNO.HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of C13H16ClNO.HCl to their clients by showing that a C13H16ClNO.HCl CEP has been issued for it. The manufacturer submits a C13H16ClNO.HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a C13H16ClNO.HCl CEP holder for the record. Additionally, the data presented in the C13H16ClNO.HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the C13H16ClNO.HCl DMF.
A C13H16ClNO.HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. C13H16ClNO.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 C13H16ClNO.HCl suppliers with CEP (COS) on PharmaCompass.
A C13H16ClNO.HCl written confirmation (C13H16ClNO.HCl WC) is an official document issued by a regulatory agency to a C13H16ClNO.HCl manufacturer, verifying that the manufacturing facility of a C13H16ClNO.HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting C13H16ClNO.HCl APIs or C13H16ClNO.HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a C13H16ClNO.HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of C13H16ClNO.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 C13H16ClNO.HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for C13H16ClNO.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 C13H16ClNO.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 C13H16ClNO.HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a C13H16ClNO.HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of C13H16ClNO.HCl suppliers with NDC on PharmaCompass.
C13H16ClNO.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 C13H16ClNO.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 C13H16ClNO.HCl GMP manufacturer or C13H16ClNO.HCl GMP API supplier for your needs.
A C13H16ClNO.HCl CoA (Certificate of Analysis) is a formal document that attests to C13H16ClNO.HCl's compliance with C13H16ClNO.HCl specifications and serves as a tool for batch-level quality control.
C13H16ClNO.HCl CoA mostly includes findings from lab analyses of a specific batch. For each C13H16ClNO.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.
C13H16ClNO.HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (C13H16ClNO.HCl EP), C13H16ClNO.HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (C13H16ClNO.HCl USP).
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