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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
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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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High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Application : Parenteral
Excipient Details : Used as an osmolarity agent in culture media, tonicity adjuster in ophthalmics and parenterals solutions.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised packaging (from grs to kilograms)
Ingredient(s) : Sodium Chloride Excipient
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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 Ketamine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ketamine Hydrochloride, including repackagers and relabelers. The FDA regulates Ketamine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ketamine Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ketamine Hydrochloride supplier is an individual or a company that provides Ketamine Hydrochloride active pharmaceutical ingredient (API) or Ketamine Hydrochloride finished formulations upon request. The Ketamine Hydrochloride suppliers may include Ketamine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Ketamine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ketamine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Ketamine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Ketamine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Ketamine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ketamine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Ketamine Hydrochloride USDMF includes data on Ketamine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ketamine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ketamine Hydrochloride 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 Hydrochloride Drug Master File in Japan (Ketamine Hydrochloride JDMF) empowers Ketamine Hydrochloride 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 Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Ketamine Hydrochloride 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 Hydrochloride suppliers with JDMF on PharmaCompass.
A Ketamine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Ketamine Hydrochloride Certificate of Suitability (COS). The purpose of a Ketamine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ketamine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ketamine Hydrochloride to their clients by showing that a Ketamine Hydrochloride CEP has been issued for it. The manufacturer submits a Ketamine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ketamine Hydrochloride CEP holder for the record. Additionally, the data presented in the Ketamine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ketamine Hydrochloride DMF.
A Ketamine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ketamine Hydrochloride 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 Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Ketamine Hydrochloride written confirmation (Ketamine Hydrochloride WC) is an official document issued by a regulatory agency to a Ketamine Hydrochloride manufacturer, verifying that the manufacturing facility of a Ketamine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ketamine Hydrochloride APIs or Ketamine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Ketamine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Ketamine Hydrochloride 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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ketamine Hydrochloride 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 Hydrochloride 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 Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ketamine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ketamine Hydrochloride suppliers with NDC on PharmaCompass.
Ketamine Hydrochloride 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 Hydrochloride 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 Hydrochloride GMP manufacturer or Ketamine Hydrochloride GMP API supplier for your needs.
A Ketamine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Ketamine Hydrochloride's compliance with Ketamine Hydrochloride specifications and serves as a tool for batch-level quality control.
Ketamine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Ketamine Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Ketamine Hydrochloride EP), Ketamine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ketamine Hydrochloride USP).
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